[{"title":"Nanolek allocated 8 million rubles to help schools","tag":null,"source":null,"date":"30.08.2024","content":"_In anticipation of the new school year, Nanolek helped to put in order the infrastructure of schools and a kindergarten in Lyovintsy urban-type settlement and Strizhi urban-type settlement in Orichevsky District of Kirov Region. With 8 million rubles allocated by the company, the territory of the secondary school in Lyovintsy was paved and the school heating mains were repaired, the floor was renovated in “Skazka” kindergarten and new windows were installed in the music room; all the internal doors and windows in the corridor were replaced, and new windows were installed in the art school. For the secondary school in Strizhi, the company purchased furniture for the classroom: 30 desks and 30 chairs for students, as well as a table and a chair for the teacher._\n\nNanolek is developing the social infrastructure of Orichevsky District within the framework of the roadmap signed by the company and the Government of Kirov Region at the end of the last year. The agreement became a logical continuation of Nanolek's policy in the social sphere. The company has previously actively helped the local school and kindergarten. Thus, in 2021-2022, with co-financing from Nanolek, window blocks were replaced and three large classrooms were renovated in the secondary school of Lyovintsy urban-type settlement: chemistry, physics, and biology studies, which were then used to house the natural science center \"Growth Point\". In addition, the gym and the roof of the building were renovated, and work was carried out to prepare documentation and submit an application for participation in the capital repairs program. In “Skazka” kindergarten, Nanolek helped to repair the entry elements and to replace the windows, as well as to purchase kitchen equipment.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_zdanie_d8484229a4.png","link":"/en/news/companynews/Nanolek-allocated-8-million-rubles-to-help-schools/","strapi":true,"compare_date":"2024-08-29T21:00:00.000Z"},{"title":"Vaccines Save Millions of Children from Polio","tag":null,"source":null,"date":"26.08.2024","content":"_August 26 marks the 118th birthday of Albert Sabin, the creator of the polio vaccine. According to a recent survey by the Russian Public Opinion Research Center, polio remains one of the most significant threats to children's health in the eyes of parents. WHO estimates that Sabin, a Russian-born American virologist who made the discovery in the early 1960s, has prevented approximately 500,000 deaths and saved 5 million people from disability. Soviet virologist Mikhail Chumakov later used Sabin's weakened strains of the virus to create a live oral vaccine that played a crucial role in halting the spread of polio in our country and other parts of the world, including the successful elimination of major outbreaks in Eastern Europe and Japan._\n\nPoliomyelitis is incurable and can only be prevented through vaccination. Several doses of the vaccine can help build lifelong immunity in a child, protecting them from the potentially fatal consequences of the disease. According to UNICEF, more than 20 million people around the world are able to walk today thanks to vaccination. Due to high childhood vaccination rates, Russia has been polio-free since 2002. However, with globalization, the risk of infection remains as long as polio-endemic countries exist. Currently, these countries are Pakistan and Afghanistan.\n\nThe threat of polio and its consequences is recognized not only by health professionals but also by parents. In a survey on attitudes toward child vaccination conducted by the Russian Public Opinion Center in May this year, Russian parents ranked polio as the second most dangerous infectious disease after meningitis.\nAs the largest vaccine company in the Russian Federation and a socially responsible manufacturer, Nanolek is committed to ensuring that polio vaccinations are accessible to Russian children. In 2017, Nanolek became the first company to localize the production of inactivated polio vaccine in Russia, using Salk strains.\n\nToday, in collaboration with the Federal Scientific Center for Research and Development of Immunobiological Drugs named after M. P. Chumakov of the Russian Academy of Sciences, Nanolek produces a vaccine based on Sabin strains. Additionally, our biomedical complex manufactures a combined vaccine that protects against five dangerous infections, including inactivated poliovirus types 1, 2, and 3. Polio prevention vaccines are provided to Russian children free of charge as part of the national preventive vaccination schedule.\n\nNanolek closely monitors global trends in healthcare and vaccine prevention. Arina Privalova, the company’s Director of Strategic Development, discussed current trends in polio vaccine prophylaxis:\n\n“There are two types of vaccines used worldwide for polio prevention: oral vaccines in the form of drops and inactivated vaccines administered by injection. Vaccines based on Sabin strains are considered the safest, with the fewest side effects. Depending on the epidemiological situation in a country and the level of vaccination coverage, WHO recommends different vaccination schedules. The basic recommended schedule is three doses of oral vaccine followed by two doses of inactivated vaccine. In countries with a favorable polio epidemiologic situation, vaccination can start with two doses of inactivated vaccine, followed by at least two doses of oral vaccine. This approach has been shown to provide a high level of protection against infection and to significantly reduce the risk of vaccine-associated paralytic poliomyelitis. Polio-free countries, like Russia, and those with a low risk of importation can opt for a schedule that involves administering only the inactivated vaccine. All types of polio vaccines are available in the Russian Federation, including both inactivated and oral vaccines, containing either wild or Sabin strains, particularly Nanolek’s vaccines, which include inactivated poliovirus types 1, 2, and 3.”\n\n**For reference:**\n\nPoliomyelitis is a dangerous viral disease. The virus is primarily transmitted from person to person through the fecal-oral route and multiplies in the intestines. Children under the age of 5 are at high risk. According to WHO, polio affects the nervous system and can cause complete paralysis in a short period of time. Approximately one in 200 infected individuals develops irreversible paralysis. In 5-10% of cases, the disease leads to death due to paralysis of the respiratory muscles.\nIn the Russian Federation, vaccination against poliomyelitis is conducted according to the national preventive vaccination schedule as follows: inactivated polio vaccine is administered at 3 months, 4.5 months, and 6 months. Revaccination is performed at 18 months with the inactivated vaccine, and at 20 months and 6 years with the oral polio vaccine.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_5e5c059582.jpg","link":"/en/news/companynews/Vaccines-Save-Millions-of-Children-from-Polio/","strapi":true,"compare_date":"2024-08-25T21:00:00.000Z"},{"title":"Nanolek is set to introduce an innovative treatment for Hunter syndrome in Russia","tag":null,"source":null,"date":"21.08.2024","content":"_**Nanolek** continues to expand its orphan drug portfolio. As part of its ongoing collaboration with the South Korean biopharmaceutical company **GC Biopharma**, Nanolek is set to expand its portfolio to include an innovative treatment for Hunter syndrome (mucopolysaccharidosis type II), known as **Hunterase Neuro**. The initial shipment of this drug, aimed at treating the first patients, is scheduled for November of this year._\n\nIn June, the Nanolek delegation, including Artyom An, Deputy General Director for Strategic Development, and Dmitry Dvinin, Product Manager, visited Okayama Medical Hospital in Japan. Dr. Furuojo, Chief Physician, Pediatrics Department, conducted a master class on administering the Hunterase Neuro injection. During the visit, doctors shared clinical data demonstrating the safety and efficacy of the drug.\n\nNanolek representatives participated in the Hunterase L.I.N.K. Day, organized by GC Biopharma. This event brought together doctors from Russia, Japan, and Colombia to share their experiences in treating Hunter syndrome. They discussed data from the Hunterase Neuro clinical trial, the drug usage experiences, and the implantation procedure for the Ommaya reservoir. This reservoir, which is used to deliver a small volume but highly concentrated enzyme directly into the patient’s brain can be used for a long-term period due to its low invasiveness. In addition, microbiological infections due to the use of drug was not observed, which attributed to the short duration of the injections.\n\nThe collaboration between Nanolek and GC Biopharma began in 2015 and led to the introduction of the drug Hunterase in Russia in 2018. Developed by South Korean biotechnologists, Hunterase is used for intravenous administration as part of enzyme replacement therapy for Hunter syndrome. The innovative drug Hunterase Neuro is administered intraventricularly—directly into the brain's ventricles—using an Ommaya reservoir. Scientists believe this method increases the effectiveness of the therapy.\n\n**For reference:**\nHunter syndrome, also known as mucopolysaccharidosis type II, is a rare genetic disorder caused by a deficiency of the enzyme iduronate-2-sulfatase. This deficiency leads to an accumulation of glycosaminoglycans in the body, resulting in damage to various organs and tissues.","image":"https://content-nanolek.ru/uploads/Shapka_na_sajt_23e52becf4.jpg","link":"/en/news/companynews/Nanolek-is-set-to-introduce-an-innovative-treatment-for-Hunter-syndrome-in-Russia/","strapi":true,"compare_date":"2024-08-20T21:00:00.000Z"},{"title":"Nanolek has implemented several initiatives to ensure its technological sovereignty","tag":null,"source":null,"date":"18.07.2024","content":"_**Nanolek** has transitioned to cooperation with Russian suppliers and local machine tool companies._\n\n\"The Russian government has set a challenging goal of import substitution across various sectors, including pharmaceuticals. Nanolek is committed to this initiative, steadily increasing the use of domestically produced products and components,\" said **Vladimir Nesterenko, CEO of Nanolek**.\n\nBetween 2022 and 2023, the **Nanolek** facility in Kirov successfully introduced more than ten alternative sources of raw materials, primarily from India and China. Significant efforts are also being made to adopt Russian software solutions.\n\nTo replace foreign technology equipment parts and maintenance spares, Nanolek's engineering team creates detailed specifications for the required components. Local firms, such as Stalnaya Marka, Detali Mashin, and IE Rukavishnikov, then manufacture these parts. In the past year and the first quarter of this year, Nanolek ordered 6,500 units from local suppliers for a total of more than 10.5 million rubles.\n\n**The Ministry of Industry, Entrepreneurship, and Trade of the Kirov region** has actively assisted in locating the necessary manufacturing facilities. To date, with the help of this department, **Nanolek** has partnered with seven enterprises. Additionally, the regional Industrial Development Fund is supporting Nanolek's proposal to establish a research and production center for pharmaceutical development in the Orichevsky district, including a production facility for a human papillomavirus vaccine under the Development Projects program.\n\nCooperation with Kirov machine-tool companies has brought more than just financial benefits. For certain equipment components, Kirov engineers have made enhancements and modernizations, such as material replacements, which extend the equipment's lifespan.\n\nFurthermore, Nanolek’s syringe filling and capping line has been upgraded with blocks of equipment elements to improve productivity and maintain sterility. \n\nThis year, the company also fully transitioned to Russian printing firms for the production of labels, medical usage instructions, and consumer packaging, using locally sourced materials.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_a274872767.jpg","link":"/en/news/companynews/Nanolek-has-implemented-several-initiatives-to-ensure-its-technological-sovereignty/","strapi":true,"compare_date":"2024-07-17T21:00:00.000Z"},{"title":"Vaccination: A Cornerstone of Family Care","tag":null,"source":null,"date":"08.07.2024","content":"_On July 8th, we celebrate **the Day of Family, Love, and Fidelity** across our nation—a perfect opportunity to reflect on how the greatest expression of love for our families and loved ones is taking care of their health._\n\nIt's widely recognized that prevention is better than cure. At **Nanolek**, we embody this principle by developing high-quality, modern vaccines to prevent viral and bacterial infections. We firmly believe that vaccination is the most effective form of protection. Today, vaccines are available to prevent over 20 life-threatening diseases, helping people live longer, healthier lives.\n\nOne of Nanolek's primary goals is to ensure that every child in our country has access to modern vaccines. Each year, over 3 million children in Russia are vaccinated with our products, building immunity against dangerous diseases such as polio, meningitis, whooping cough, tetanus, diphtheria, and pneumococcal infections. Our scientists are also advancing research into new vaccines for the human papillomavirus (HPV) and shingles.\n\nTaking responsibility for the health of our families and loved ones is a collective duty. Don’t gamble with your most valuable assets. Register your children for vaccination and make sure you are vaccinated as well. Many vaccines are available free of charge in our country. Visit your local clinic, consult with a doctor, and find out which vaccines are available to you through the national and regional vaccination schedules.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_5e5c059582.jpg","link":"/en/news/companynews/Vaccination-A-Cornerstone-of-Family-Care/","strapi":true,"compare_date":"2024-07-07T21:00:00.000Z"},{"title":"Nanolek's New R&D Center to Develop Cutting-Edge Domestic Vaccines","tag":null,"source":null,"date":"02.07.2024","content":"_**Nanolek** is set to establish a new **research and development (R&D) center** focused on transferring and advancing the technology for the production of domestic vaccines, including those against the human papillomavirus (HPV), shingles, and other infections. **Nanolek** aims to handle the full cycle of drug creation — from the active pharmaceutical ingredients to the final dosage forms. The center will be created within the company’s biotechnological complex in the Kirov region._\n\n**Nanolek** will open a research and development center for pharmaceutical development as part of its investment program, aimed at creating new capacities for the production of biotechnological substances and full-cycle vaccines to combat socially significant diseases, including those against human papillomavirus and shingles. The new R&D center will build on the legacy of the company’s Early Development Center, which was previously located in the Pushchino science town near Moscow.\nOne of the primary objectives of the Center's team will be to develop vaccines starting from the active ingredient stage through to preclinical and clinical trials, and then scaling up to production. The proximity of the R&D Center to Nanolek’s biomedical complex is crucial for facilitating the transfer of production technologies to an industrial scale.\n\nIt's worth noting that **Nanolek** plans to invest 5 billion rubles to expand production capacities and add new lines at the plant for producing the HPV vaccine and other pharmaceuticals. Close cooperation between the scientists at the **R&D center** and the production team will be mutually beneficial. Biotechnologists will gain insight into the capacities needed to scale up drug production from the earliest stages of development, while production specialists will be able to take the scientists' input into account when creating and upgrading production lines.\n\n**Nanolek** has tasked the biotechnologists of the **R&D center** with transferring the first domestic HPV vaccine to the production facilities of the biotechnological complex. It is important to note that this vaccine is currently undergoing Phase III clinical trials in children and adolescents. In addition, Nanolek scientists are actively working on the genetic design, cultivation processes, isolation, and purification of antigens for a shingles prevention vaccine. The start of preclinical studies for this vaccine is scheduled for early 2025.\n\nThe scientific and practical center will occupy an area of 300 square meters and will be equipped with all necessary equipment for the development and production of vaccine batches for preclinical and clinical studies, including advanced laboratory facilities. Immediate plans include obtaining a license for activities involving the use of infectious agents from the III-IV groups of pathogenicity. This will allow to work with attenuated strains of pathogens, which are incapable of causing infection, as well as with model platforms such as E. coli or yeast cells for the development of recombinant antigens. The safety of the production facility and its personnel will be ensured. The vaccines produced will comply with domestic and international standards for efficacy and safety. Although the recombinant vaccines developed at the center cannot cause infection, they will enable the human immune system to develop antibodies, establish a memory of the antigen, and effectively protect the body from disease when confronted with a real infection.\n\nWith the establishment of the Center for Pharmaceutical Development in the Kirov region, Nanolek is strengthening its cooperation with another key regional institution, **Vyatka State University**. Vyatka State University has one of the country’s largest educational and scientific-applied bases, equipped with modern analytical laboratories. This infrastructure not only trains high-level specialists but also supports all necessary research activities. Traditionally, **the Nanolek biomedical complex** has served as a practical training and internship site for university students. Now, these future scientists will have the opportunity to acquire specialized skills at the Research and Development Center and potentially pursue careers there. As a result, Vyatka State University will play a direct role in the development of domestic vaccines.\n\n**Vladimir Nesterenko, CEO of Nanolek, states:**\n\"Developing our own technology for producing active pharmaceutical ingredients is a strategic priority for us. Achieving this goal will enable us to manufacture vaccines in Russia on a full-cycle basis. Establishing our own research and development center is an important step in this direction. **Nanolek** has the necessary expertise in this area. The new division will draw on the experience of our early development center in Pushchino, but it will focus not only on scientific but also on practical applications. This is why we are locating the center close to our production site. It will be integrated into the plant's pharmaceutical safety system, and its employees will have the opportunity to scale up technologies developed on-site. We are planning to allocate about half a billion rubles to equip the center. Our current focus is on HPV and shingles vaccines. By 2030, we aim to develop five additional vaccines. All our efforts are aimed at enhancing vaccine accessibility for the people of our country and ultimately protecting public health, which aligns with Nanolek's mission.\"","image":"https://content-nanolek.ru/uploads/5_e7e5cc83d6.jpg","link":"/en/news/companynews/Nanolek's-New-R_D-Center-to-Develop-Cutting-Edge-Domestic-Vaccines/","strapi":true,"compare_date":"2024-07-01T21:00:00.000Z"},{"title":"Nanolek Takes Part in the Second Russian-Chinese Pharmaceutical Forum","tag":null,"source":null,"date":"27.06.2024","content":"_Nanolek's delegation, led by **CEO Vladimir Nesterenko**, participated in the Second Russian-Chinese Pharmaceutical Forum held in Shanghai, China, as part of the CPHI China International Pharmaceutical Exhibition. The team also successfully engaged in numerous discussions with local companies._\n\nThe Forum featured a diverse lineup of speakers who addressed a wide range of topics related to collaboration between Russian and Chinese companies in areas such as research and development, clinical trials, registration, quality control, localization, and the import and export of pharmaceutical products.\n\nDuring the general panel discussion at the Forum, **Nanolek** was represented by **Arina Privalova, Director of Strategic Development**. In a Nanolek's separate private meeting with Chinese companies, she emphasized the following:\n\n\"Although Russia has a much smaller population compared to China, the monetary value of our pharmaceutical market is only four times smaller than that of China, making it quite comparable to other major markets like India. This presents a valuable opportunity for Chinese companies looking to expand internationally. There is great interest from these companies in entering the Russian market, both in terms of new products launch and joint technology development and transfers. During the private meeting, we outlined the regulatory framework of the Russian market and discussed the most effective strategies for market entry with representatives of Chinese companies. The feedback was overwhelmingly positive and confirmed the strong interest of our Chinese colleagues in the Russian pharmaceutical sector.\"\n\nIn addition to participation from Russian and Chinese companies, the Forum also saw attendance from representatives of government regulatory agencies, including the Ministry of Health and the Ministry of Industry and Trade of the Russian Federation, as well as the Chinese Association of Pharmaceutical Manufacturers and the Chinese Chamber of Commerce for Import and Export of Medicines and Healthcare Products.\n\nDuring the Forum, government priorities for pharmaceutical cooperation with China were made public. **Ekaterina Prieszheva, Deputy Minister of Industry and Trade of the Russian Federation**, emphasized Russia's greatest interest in the technology transfer and localization of full-cycle production for biotech drugs, treatments for rare diseases, and drugs not yet registered in the country. These priorities are closely aligned with Nanolek's strategic development goals.\n\n**Nanolek** is actively expanding its collaboration with biotechnology companies in China. During a recent working visit, Nanolek representatives successfully conducted negotiations with twelve Chinese pharmaceutical companies and visited two production facilities that manufacture innovative vaccines. These discussions are expected to soon lead to several partnership agreements.\n\n**Nanolek** has established itself as a reliable and trustworthy partner in the Chinese pharmaceutical market. It is worth mentioning that this year **Nanolek**, through its cooperation with the international oncology company **BeiGene**, will resume the supplies of **Brukinsa**, an anticancer medicine, to Russia.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_2_caf2c6c8c7.jpg","link":"/en/news/companynews/Nanolek-Takes-Part-in-the-Second-Russian-Chinese-Pharmaceutical-Forum/","strapi":true,"compare_date":"2024-06-26T21:00:00.000Z"},{"title":"Sber Pro: Alexey Pavlov, Director of BMC Nanolek, Discusses Biotechnology Development in Russia","tag":null,"source":null,"date":"11.06.2024","content":"**Alexey Pavlov, Director of the Nanolek Biomedical Complex**, shared insights with Sber Pro on the biotechnology development and the company’s strategic direction:\n\n\"Nanolek is focused both on creating new vaccines and significantly expanding its production capabilities. Last year, our quadrivalent recombinant human papillomavirus (HPV) vaccine, **Tsegardex**, successfully completed its preclinical studies and Phase III clinical trials in adults. In 2024, **Nanolek** obtained approval from the Ministry of Health to begin Phase III trials of the HPV vaccine in children and adolescents aged 9 to 17.\"\n\n**Nanolek** specializes in the development of innovative biotechnological products. By 2032, the company plans to invest an additional 5 billion rubles in production expansion. These funds will support the development and manufacturing of biotechnological substances, which are raw materials for drug production, and a vaccine against human papillomavirus, including formulations for children.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_2_69199e00f4.jpg","link":"/en/news/companynews/Sber-Pro-Alexey-Pavlov,-Director-of-BMC-Nanolek,-Discusses-Biotechnology-Development-in-Russia/","strapi":true,"compare_date":"2024-06-10T21:00:00.000Z"},{"title":"Brukinsa Anticipated to Join the List of Vital and Essential Drugs","tag":null,"source":null,"date":"10.06.2024","content":"_**Nanolek** has submitted an application to include the anticancer drug **Brukinsa** in the list of Vital and Essential Drugs (VED). In 2021, the Ministry of Health of the Russian Federation approved **Brukinsa** for the treatment of adult patients with mantle cell lymphoma._\n\nDeveloped by scientists at the international oncology company **BeiGene**, **Brukinsa** is globally recognized in clinical programs for the treatment of B-cell malignancies. Under the terms of the strategic partnership formed with **BeiGene** in 2020, **Nanolek** has obtained exclusive rights for the distribution, promotion, pharmacovigilance, and secondary packaging and quality control of **Brukinsa** in Russia and the countries of the Eurasian Economic Union. Discussions are underway to localize drug production within Russia.\n\nAfter a brief interruption in March 2022, **Brukinsa** supplies to Russia have now resumed under the continued partnership between **Nanolek** and **BeiGene**.\n\nAdding **Brukinsa** to the VED list will improve access for patients struggling with relapsed or refractory mantle cell lymphoma, a particularly rare and aggressive type of non-Hodgkin’s lymphoma that predominantly affects the elderly and is often diagnosed at an advanced stage. Each year, more than a thousand new cases are diagnosed in Russia.\n\nThe VED list includes more than 800 international generics and more than 5,000 trade names, the prices of which are regulated by the government. A special commission of the Ministry of Health of the Russian Federation is responsible for the compilation of the VED list, which is subsequently approved by the Government.","image":"https://content-nanolek.ru/uploads/zavod_na_sajt_1ff4d61f7c.jpg","link":"/en/news/companynews/Brukinsa-Anticipated-to-Join-the-List-of-Vital-and-Essential-Drugs/","strapi":true,"compare_date":"2024-06-09T21:00:00.000Z"},{"title":"Kommersant: Vladimir Nesterenko, CEO of Nanolek, Discusses Vaccine Localization","tag":null,"source":null,"date":"03.06.2024","content":"_**Vladimir Nesterenko, CEO of Nanolek**, told Kommersant why the company, which has traditionally relied on cooperation with international partners, is now focusing on **a complete in-house production cycle and technology transfers**._\n\n**— This year, there has been a significant increase in the number of unsuccessful state tenders for medical purchases. How critical is this for medical institutions, and what do you think is causing it?**\n\n— When setting initial prices for auctions, the costs from previous tenders are considered. However, some companies deal with excess products and offer small drug quantities to regions at very low prices. This practice influences the pricing at major federal auctions, which these smaller companies do not participate in. As a result, large market players find it unsustainable to supply drugs in large quantities at such reduced prices.\n\n**— How do you think can we reverse this trend?**\n\n— I believe we need a different approach to pricing that takes into account production capacity, market demand, and the actual costs involved in drug manufacturing. Pricing should also be more flexible to accommodate various factors, such as changes in the ruble exchange rate. For instance, it could be beneficial to allow price adjustments during the term of a government contract.\n\n**—The deadline for including new vaccines in the National Vaccination Schedule (NVS) for 2023 has been postponed. How has this affected your company's plans to develop new products?**\n\n— My perspective on this may differ from that of officials who believe that manufacturers should first produce a domestic vaccine before it is considered for inclusion in the schedule. I think the government should assign manufacturers specific tasks—be it for polio, chickenpox, or meningitis—regardless of the terminology. The companies should then fulfill these tasks, whether by first importing vaccines into Russia and later localizing production or by developing new drugs domestically from the start.\nIn reality, pharmaceutical companies often decide to start producing certain vaccines based on the expansion plans of the NVS, taking on considerable risk. For Nanolek, this approach applies to our development of vaccines for meningococcal disease and varicella, as well as the herpes vaccine we are currently developing.\n\n**— Why did you choose to develop this particular vaccine?**\n\n— This vaccine has significant potential. Globally, it is increasingly being administered to older adults and the elderly to prevent infections to which they are more susceptible due to weakened immune systems.\n\n**— Are there many companies producing this vaccine worldwide?**\n\n— No, the market is quite limited with only two or three manufacturers.\n\n**— Until April 2023, Nanolek was a part of Vladimir Khristenko's structures and his partners. Then, the business transitioned to Management-Aktiv CEIF, managed by K2 Group (main co-owners are Sergey Ostashevich's Interno Invest and Vasily Kulkov's DD Kalita (son of Egor Kulkov, co-founder of Pharmstandard). You then took over the company. What objectives were you tasked with when you took over?**\n\n— When I joined, Nanolek was well performing business with a robust portfolio of drugs, substantial orders, and strong financials. The primary objective in such a scenario is to maintain the existing success. I believe we have achieved this. Rather than being given specific tasks, the challenges are more self-imposed.\n\nWe recognize that to thrive, especially in the current challenging climate where many companies have left the Russian market, development and innovation are crucial. \nOne of our key goals is to achieve technological sovereignty and pharmaceutical independence for the country. We need to establish our own vaccine production through a full-cycle process, which includes the creation of a cell bank, which is our current focus.\n\n**— Does the goal of full-cycle production apply to specific products?**\n\n— It's an integral part of our overall strategy. Even the transfer of technology to prepare the final dosage form is extremely challenging. Not only is it costly, but the process of technology transfer also requires extensive expertise, production readiness, and several years of dedicated effort.\nWe recognize that even after obtaining a Russian manufacturing certificate, we will still be dependent on our international partners who have the necessary know-how. \nAs a result, it is imperative that we develop our own products that are produced entirely in-house, from the creation of the cell bank and the active pharmaceutical ingredients to the final product.\n\n**— You have a long-standing partnership with Sanofi. Do you plan to manufacture own products at the same time?**\n\n— We collaborate with Sanofi on two products—the Menactra meningococcal vaccine and the Pentaxim pentavalent vaccine. Sanofi is a strategic partner for us, and we plan to further develop our relationship. We also have agreements to deepen our production processes.\n\n**— You have a full production cycle for Pentaxim, haven’t you? How profitable is the production, especially since your company has faced challenges trying to increase the vaccine's marginal price?**\n\n— Currently, we are only involved in the aseptic filling stage, not in the production of the substance itself. Pentaxim is a complex drug with a 36-month production cycle and is marketed in both France and Russia. For several years, the margins from Pentaxim have been sufficient for us to operate profitably and invest in our production capabilities, including plans to deepen localization in cooperation with Sanofi. However, fluctuations in the ruble exchange rate in 2022 pushed the product to the brink of profitability. By the end of 2023, losses from the Pentaxim project exceeded 300 million rubles.\nIn 2023, we approached the Ministry of Health to explore the possibility of raising the marginal price. We were advised to utilize Government Decree No. 1771, which allows for the revision of marginal prices for drugs deemed economically inefficient, and we acted on this advice. This resulted in the re-registration of the maximum price per package of the drug to 1.36 thousand rubles, up from 1.079 thousand rubles.\nDespite these adjustments, the profitability of the project is now only 6%, which is half of our target rate of return. This experience has shown that although Government Decree No. 1771 is an effective policy, the process of implementing price changes is lengthy.\n\n**— What other factors affect the pricing of pharmaceutical products?**\n\n— The cost of pharmaceuticals is affected by a number of factors including rising prices for energy, raw materials, supplies, software updates, and equipment replacement. Another significant issue is that pharmaceutical manufacturers often artificially limit their profitability, which hinders development and leads to stagnation. Profits of manufacturers are vital for developing production capacities, acquiring and creating new technologies, generating employment, and eventually contributing back to the state in the form of taxes.\n\n**— Nanolek supplies the National Vaccination Schedule with the pneumococcal vaccine Pnemotexbased on raw materials from South Korean SK Biosciences. However, in the summer of 2023, the Seoul Central District Court ruled that your partner had infringed on a Pfizer patent. Are you still able to source these raw materials?**\n\n— We transferred the technology and started to produce Pnemotex using SK Biosciences’ raw materials. However, we faced a situation when the South Korean side indicated that they could no longer supply us due to patent restrictions, halting our production of the vaccine from these materials.\nNevertheless, we are actively working on localizing production and are looking for new partners. We are also in discussions with SK Biosciences about transferring the cultivation stage of the active pharmaceutical ingredient to our facility, as it is not covered by patent restrictions. In addition, we plan to acquire a cell bank to establish a full-cycle production. These negotiations are complex but ongoing.\nAdditionally, Pfizer’s vaccine is expected to lose patent protection by 2026, which may ease some restrictions quite soon. Meanwhile, SK Biosciences is appealing the court ruling to a higher court. With new pneumococcal vaccines containing up to 16, 20, and 21 serotypes emerging globally or under development, we are also exploring these opportunities.\n\n**— In Russia, Poliovaxin is currently the only inactivated monovaccine against poliomyelitis, produced by the joint venture between Nanolek and the Chumakov Center. Is the production volume sufficient to meet the demand within Russia?**\n\n— Pricing also plays a role in this scenario. We started production of Poliovaxin in collaboration with the Chumakov Center using leftover consumables from our production of CoviVac, another vaccine developed by the Center. The initial registered price was 390.46 rubles per dose. However, after depleting the initial supplies, the costs—and consequently the marginal price—were recalculated. We initially filed for a price re-registration to 1.1 thousand rubles per dose under Decree No. 1771. Following further analysis by the Chumakov Center, which considered supplier departures and economic changes, the cost per dose was adjusted to 1.8 thousand rubles. According to the Center, it’s now impossible to produce the vaccine at the previous price under the new economic conditions.\nWe are in constant dialogue with the Chumakov Center as this is our joint product. We've proposed to transfer the technology to our facilities. With our existing vaccine portfolio, we may be able to optimize the production process and reduce the costs of producing Poliovaxin, although this could take up to two years.\n\n**— Is Nanolek currently producing the vaccine?**\n\n— We are one of the facilities involved in the filling phase of vaccine production.\n\n**— Would you consider restarting production of another polio vaccine, Polimilex, using raw materials from the Dutch company Bilthoven Biologicals?**\n\n— We have resumed discussions with Bilthoven Biologicals to transfer the technology to our facility. However, these negotiations are challenging. Bilthoven is understandably concerned about the possibility of losing access to the Russian market again.\n\n**— What is the current status of the human papilloma vaccine developed by Nanolek?**\n\n— We have started the third phase of clinical trials, which now includes children. We hope to complete these trials by the end of 2025, which will allow us to proceed with registration for expanded indications. In addition, we are building a production facility at our site specifically for this vaccine. Our goal is to fully meet the domestic demand for the vaccine in Russia, with plans to begin exporting it thereafter.\n\n**— Do you currently export any of your products?**\n\n— Not at the moment. However, we have identified two vaccines, including those for polio and human papillomavirus (HPV), that have the potential for export in the future.\n\n**— Nanolek has announced plans to invest 5 billion rubles to expand its facilities in Kirov. What products do you plan to produce there?**\n\n— We are allocating at least two sites for the production of the varicella vaccine and the human papillomavirus (HPV) vaccine. We are in talks with a South Korean partner to produce a live varicella vaccine, a product not yet domestically available in Russia. We aim for full-cycle localization in the future, but this will require significant investment. Firstly, the construction of a facility equipped to handle live vaccines requires specific conditions, and secondly, the cost of the technology itself is quite substantial. Initially, the vaccine will be imported in a frozen state.\nWe're also exploring the production of a pneumococcal vaccine, starting with the development of a cell bank and the cultivation of the active pharmaceutical ingredient, if we can secure the necessary technology. If negotiations on polio are successful, this site could also become a new center for polio vaccine production.\n\n**— Are you preparing any other products for the commercial market?**\n\n— Yes, for instance, the herpes zoster vaccine is aimed at this segment. We are also looking into producing quadrivalent and nonavalent HPV vaccines.\n\n**— Nanolek has registered two drugs based on monoclonal antibodies, Bevacizumab and Rituximab. Are there plans to introduce more biologic drugs to the market?**\n\n— Rituximab has been available for a year, and we are launching Bevacizumab this year. However, these are currently the only monoclonal antibody products for Nanolek. We have determined that competing with major players in the market to produce a wide range of monoclonal and polyclonal antibodies is not our ambition. We aim to excel in our areas of expertise, and we welcome others to try to replicate our success. This same philosophy guided our decision to opt out of producing antiretroviral drugs.\n\n**— Are there any plans to manufacture in Russia the oncology drug Brookinza, based on Zanubrutinib from BeiGene? According to Roszdravnadzor, only one batch was released in Russia in 2021.**\n\n— We've made significant progress in this area. We have been negotiating and consulting with BeiGene for almost a year and a half. Brookinza has demonstrated excellent clinical results and has the potential for broader use than currently approved. The methods of control were also being revised, which temporarily halted its supply.\nBeiGene has recently confirmed that the first 108 packs of Brookinza will be delivered to us by the end of May. We expect to evaluate the demand from our medical institutions by the end of this year and assess our production capabilities. By 2025, we aim to begin systematic deliveries of this product to the Russian Federation in the required quantities. In addition, we have submitted an application to include this drug in the list of vital medications.\n\n**— Do you plan to expand your partnership with BeiGene?**\n\n— Yes, we are discussing another product with BeiGene. Given their strong focus on oncology, BeiGene has significant potential in this field, partly due to their collaborative efforts with partners.\n\n**— Have Chinese pharmaceutical companies shown increased interest in the Russian market recently?**\n\n— Absolutely, and our interest in Chinese companies has grown as well. \nWhile our focus was previously on Europe, China has been advancing significantly. \nWe are looking to introduce a new product to the Russian market that is currently undergoing clinical trials, not only in China. This gene therapy drug could be revolutionary for ophthalmology.\n\n**— Is Nanolek considering importing these drugs or localizing their production in Russia?**\n\n— We'll start with secondary packaging for Brookinza, and then we'll explore further options. Nanolek is not content with partial localization. However, localization of gene therapy in Russia seems unlikely at this stage. Chinese developers have previously declined to transfer technology to one of the big pharma companies they had an agreement with, opting instead to centralize production in China.","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_1_821699eaa5.jpg","link":"/en/news/companynews/Kommersant-Vladimir-Nesterenko,-CEO-of-Nanolek,-Discusses-Vaccine-Localization/","strapi":true,"compare_date":"2024-06-02T21:00:00.000Z"},{"title":"Nanolek Celebrates Anniversary by Supporting a Local Kindergarten","tag":null,"source":null,"date":"27.04.2024","content":"_**April 27, 2024, Kirov** — To celebrate its upcoming anniversary on April 27, 2024, the biotechnology company **Nanolek** organized in advance of a festive occasion a clean-up day, planting of greenery, and a celebration at the \"Skazka\" kindergarten in the village of Lyovintsy. Additionally, in partnership with the Kirov region, **Nanolek** reaffirmed its commitment to developing transportation infrastructure and continuing support for key socially critical projects in education. Plans for this year include major repairs to the \"Skazka\" kindergarten and the paving of the secondary school grounds in Lyovintsy, Orichevsky district, which will be fully funded by **Nanolek** with an investment of 6 million rubles. These initiatives are part of a broader roadmap for the development of social infrastructure in Lyovintsy, Orichevsky district, signed between Nanolek and the Kirov Region at the end of 2023._\n\nIn addition to supporting the kindergarten and school, Nanolek has also made significant contributions to the transportation sector. To improve accessibility for Lyovintsy residents and Nanolek employees, the company built a public transport stop that has been in operation since March 1, 2024. The Lyovintsy-Kirov shuttle bus (No. 155) now adjusts its route to stop at the new location “Nanolek biomedical complex” three times a day.\n\nNanolek's agreement focuses heavily on construction and landscaping aimed at creating a comfortable environment in the Orichevsky district. In 2023 alone, the company allocated over 4 million rubles for social developments, including the replacement of windows and repairs to a room at the Orichevsky House of Creativity, repairs to the roof of the House of Culture in Pustoshi village, the improvement of street lighting in Tupitsyny and Shevniny villages, the construction of a children’s playground in Usovy village, and a courtyard of apartment buildings on Kirov Street in Orichi urban-type settlement.\n\nThis agreement is a logical continuation of Nanolek's long-standing commitment to local social initiatives. Previously, the company has already co-funded significant upgrades to the local school and kindergarten, including the replacement of window blocks and the renovation of three large classrooms — Chemistry, Physics, and Biology, which then accommodated the \"Point of Growth\" science center in 2021-2022, at the secondary school in Lyovintsy. Nanolek also supported the renovation of the gym and building roof, and assisted with the paperwork and submission of application for a capital improvement program. The company also contributed to the renovation of the entrance unit of the \"Skazka\" kindergarten, replacement of windows, and provided new kitchen equipment.\n\n**Vladimir Nesterenko**, CEO of Nanolek, said: \"Supporting the local school and kindergarten is a priority for us. Our efforts are centered around Lyovintsy and the entire Orichevsky district, benefiting our current and future employees. Our company continues to grow and is focused on increasing production. Every year, over three million children across the country receive vaccines produced by us, and it's a point of pride for local residents that such essential, high-tech medications are manufactured here in Kirov. We are committed to making a long-term impact in this region.\"","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_da723213d5.jpg","link":"/en/news/companynews/Nanolek-Celebrates-Anniversary-by-Supporting-a-Local-Kindergarten/","strapi":true,"compare_date":"2024-04-26T21:00:00.000Z"},{"title":"Nanolek’s Vaccines Recognized as Some of the Top Products of the Year in the Platinum Ounce Competition","tag":null,"source":null,"date":"18.04.2024","content":"_On April 18, the jury of the 24th **Platinum Ounce** competition, a gathering of pharmaceutical industry professionals, announced the best* drugs and companies of the year. **Nanolek** secured second place in the **\"Dynamics of the Year\"** category for its supply of drugs to the public sector. Additionally, the company's **Pnemotex** and **PoliovacSin** vaccines were awarded third and fourth place, respectively, in the **\"Launch of the Year\"** category. Notably, this year marks the first time that vaccines have been listed among the competition's top products in its over 20-year history._\n\nThe awards reflect Nanolek’s significant contributions to immunoprophylaxis. The company currently leads the domestic market for pediatric vaccines, with a portfolio that includes modern immunization agents against diseases listed in the National and Regional Preventive Vaccination Schedules (NPVS and RPVS). The vaccines **Pnemotex**, which prevents pneumococcal infections, and **PoliovacSin**, which protects against three types of the poliomyelitis virus, both awarded in the **\"Launch of the Year\"** category, are available under the NPVS. PoliovacSin is produced through a joint venture between Nanolek and Invac, a federal scientific center for immunobiological drug research and development named after M.P. Chumakov of the Russian Academy of Sciences.\n\n\"Both vaccines are rapidly growing and in high demand in our portfolio. By 2030, we plan to produce an average of 3.3 million doses of **Pnemotex** and 1 million doses of **PoliovacSin** annually. Notably, PoliovacSin is the first domestic polio vaccine manufactured entirely within the Russian Federation,\" stated **Elena Stukun**, Deputy General Director for Commercial Activities at Nanolek.\n\nLooking forward, **Nanolek** aims to significantly expand its product portfolio, focusing on the development of vaccines against human papillomavirus, pneumococcus, chickenpox, and shingles. An investment of 5 billion rubles is planned for the construction of new facilities for biotechnological substances and pharmaceuticals at the Nanolek site in the Kirov region. The company also plans to expand its portfolio of original drugs for cancer and rare diseases.\n\n\"The importance of vaccine prophylaxis in supporting national healthcare policies is growing increasingly critical. With the active development of import substitution, our strategy is focused on the expansion of our product portfolio, including the development of new domestic vaccines and the enhancing of our full-cycle production capabilities,\" said **Vladimir Nesterenko**, General Director of Nanolek.\n\nThe **Platinum Ounce**, All-Russian open competition for pharmaceutical professionals, was established in 1999 and held its inaugural ceremony in 2000. Often referred to as the \"Russian Pharmaceutical Oscar,\" the competition's expert council consists of over 500 members, including top executives from leading pharmaceutical companies, health authorities, and respected public organizations and media covering the pharmaceutical sector. It is worth noting that top managers on the expert council are prohibited from voting for their own companies, drugs, or projects.\n\n*https://vk.com/video-37484482_456239669","image":"https://content-nanolek.ru/uploads/Makety_dlya_sajta_shablon_1_c93793b275.jpg","link":"/en/news/companynews/Nanolek’s-Vaccines-Recognized-as-Some-of-the-Top-Products-of-the-Year-in-the-Platinum-Ounce-Competition/","strapi":true,"compare_date":"2024-04-17T21:00:00.000Z"},{"title":"Russian Domestic HPV Vaccine Nears Final Phase of Clinical Trial","tag":null,"source":null,"date":"04.03.2024","content":"_**March 4, 2024** - The Russian Ministry of Health has granted Nanolek approval to conduct a Phase III clinical trial of its human papillomavirus (HPV) vaccine in children and adolescents aged 9 to 17. This is a pivotal phase before the vaccine becomes available on the Russian market._ \n\nThe vaccine offers protection against the four most common HPV strains (6, 11, 16, and 18) responsible for cervical cancer, other HPV-related cancers, and benign conditions such as anogenital warts. This will be the first domestically produced HPV vaccine in Russia. Currently, only international HPV vaccines are licensed and used in the country. The vaccine will be produced in the Kirov region at the Nanolek facility under Good Manufacturing Practice (GMP) standards.\n\nResearch on the Russian vaccine will be conducted at three federal research centers in Moscow, including the Sechenov First Moscow State Medical University, the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, and the Petrovsky National Research Center of Surgery, in addition to the Perm State Medical University named after Academician Wagner, the Children's City Clinical Hospital No. 11 in Yekaterinburg, and Medical Technologies LLC in St. Petersburg.\n\nThe study aims to evaluate the efficacy and safety of the new quadrivalent vaccine in the target age group, compared to an American vaccine with a similar antigen composition.\n\nThe trial is scheduled to run from March 2024 to October 2025 and will enroll 402 volunteers.\n\nIn 2023, a Phase III clinical trial, involving adult volunteers aged 18 to 45, demonstrated the safety and efficacy of the Nanolek vaccine. Most participants developed antibodies against the four most common oncogenic HPV types targeted. The vaccine's good tolerability, safety profile, and potential efficacy have been confirmed by both preclinical and clinical research. These encouraging results have justified its trial in younger demographics.\nCervical cancer, a major concern associated with HPV, is the leading cause of death among women of reproductive age in Russia and the second most common cancer among women under 45.\n\nThe World Health Organization (WHO) advocates for HPV vaccination as the most effective prevention strategy and specifically recommends it for adolescents aged 9-14 years before they become sexually active. Currently, HPV vaccination is part of the national immunization programs in 137 countries worldwide.\n\nRussia plans to include HPV vaccination in its national immunization calendar by 2026. HPV vaccination programs are already underway in 58 Russian regions, according to Rospotrebnadzor.\n\n**Vladimir Nesterenko, CEO of Nanolek**, highlighted the importance of introducing a new domestic HPV vaccine in Russia: \"Our project stands out because it aims to expand the production capabilities of our Kirov plant, enabling us to produce the vaccine in a full cycle, including the active ingredient. This is a pioneering project for the country in the field of HPV vaccination.\"\n\nSechenov University will serve as one of the key clinical trial sites. As a leading clinical and research center, the Sechenov Moscow State Medical University plans to enroll at least 30 children, marking an important step in evaluating the effectiveness of the new domestic vaccine.\n\n\"The clinical trial of Russia's first domestic HPV vaccine for children and adolescents will take place at the Children's Clinic of the Sechenov Center for Maternity and Childhood,\" said **Ekaterina Alexeeva, principal investigator of the trial, and director of the Filatov Clinical Institute of Child Health**. She is also a corresponding member of the Russian Academy of Sciences, a professor, and holds a doctorate in medical sciences. \"We are currently selecting participants aged 9 to 17 who are in good health. All children will undergo a comprehensive medical evaluation in accordance with the study protocol to minimize post-vaccination reactions before the trial begins.\"\n\nAlexeeva further clarified that only those children whose health fully meets the study's inclusion criteria will receive the vaccine. The vaccinations will be performed on an outpatient basis, with the injection administered intramuscularly. The vaccination schedule will be adjusted based on the child's age.\n\n\"Vaccination against human papillomavirus is critical for all children and adolescents because it prevents HPV-related diseases, especially cervical cancer and other cancerous conditions,\" Alexeeva concluded.","image":"https://content-nanolek.ru/uploads/3_e15463fd8f.jpg","link":"/en/news/companynews/Russian-Domestic-HPV-Vaccine-Nears-Final-Phase-of-Clinical-Trial/","strapi":true,"compare_date":"2024-03-03T21:00:00.000Z"},{"title":"February 29 – World Rare Disease Day","tag":null,"source":null,"date":"29.02.2024","content":"Observed annually at the end of February, World Rare (Orphan) Disease Day celebrates the global effort to raise awareness for rare diseases since its inception in 2008 by the European Organization for Rare Diseases.\n\nThe choice of February 29, a date known for its rarity, symbolizes the uncommon nature of these diseases, which are also known as orphan diseases. In non-leap years, the global community observes this day on February 28.\n\nIn our country, a disease is considered rare if it affects fewer than 10 people per 100,000 population. To date, there are approximately 8,000 known rare diseases.\n\nNanolek, a socially responsible pharmaceutical company, focuses on rare diseases. Its product portfolio includes an advanced treatment for Hunter syndrome, a rare disease.\n\nHunter syndrome, or mucopolysaccharidosis type II, is a hereditary, progressive disease that affects the skeletal, cardiovascular, and central nervous systems, as well as causing vision and ENT (ear, nose, and throat) problems.\n\nNanolek's drug is part of enzyme replacement therapy. At a recent roundtable discussion on mucopolysaccharidosis, ahead of World Rare Disease Day, healthcare professionals, advocates, and parents of affected children shared their experiences with the treatment. Currently, a new method for administering the drug is being introduced.\n\nHealthcare experts emphasize the need not only to treat Hunter syndrome in children but also to monitor disease progression. Nanolek is committed to improving the lives of patients through innovative therapies.","image":"https://content-nanolek.ru/uploads/shapka_na_sajt_44153f7509.jpg","link":"/en/news/companynews/February-29-–-World-Rare-Disease-Day/","strapi":true,"compare_date":"2024-02-28T21:00:00.000Z"},{"title":"Russian HPV Vaccine Successfully Passes Phase III Clinical Trials","tag":null,"source":null,"date":"17.11.2023","content":"_17.11.2023. The biopharmaceutical company Nanolek has announced the successful completion of Phase III clinical trials on the safety and efficacy of a vaccine against human papillomavirus (HPV), which causes cervical cancer. As part of the study, Nanolek's in-house vaccine demonstrated comparability to that of a vaccine produced by the American firm MSD in terms of efficacy, safety, and the formation of immunity to four types of HPV. The study was conducted and based on five clinical centers with the participation of 440 healthy adults ranging in age from 18 to 45. _\n\nThe Russian vaccine showed comparable immunogenicity, as most of the study's participants developed antibodies to all four of the most common oncogenic types of HPV (6, 11, 16, and 18), all of which the Nanolek vaccine protects against.\n\nCervical cancer ranks among the leaders in terms of mortality among women of reproductive age in Russia, that is, among the most active and able-bodied individuals (up to the age of 44). It is second in terms of prevalence among oncological diseases in women aged 14-45.\n\nIn 2020 Nanolek announced the launch of a project to develop and market an HPV vaccine. This virus causes HPV-associated diseases, including cervical cancer, anogenital warts, etc. Only foreign HPV vaccines are currently registered and used in Russia. Nanolek's vaccine will be the first domestic HPV vaccine. The Russian vaccine is planned to enter the market in 2025.\n\nNanolek announced plans at the end of October 2023 to produce a full-cycle HPV vaccine, including the substance, at its plant in the Kirov Region. The company is investing 5 billion rubles in the creation of new capacities for the production of the HPV vaccine as well as a number of other vaccines, all taking into account world standards of production and quality assurance, that is, Good Manufacturing Practices.\n\nThe new domestic vaccine will be registered in Russia under the trade name Tsegardex.\n\"According to Government Decree No. 774-r dated March 29, 2021, inclusion of the HPV vaccination into the National Immunization Schedule is planned for 2026. Thanks to this, the Russian vaccine will be available for vaccination of adolescents and will help ensure their protection from the most oncogenic types of the virus,\" commented Nanolek CEO Vladimir Nesterenko.\n\n**About the research into the Russian HPV vaccine**\n\nIn 2021 the Russian HPV vaccine successfully passed Phase I clinical trials, demonstrating at this early stage, the safety and immunogenicity indicators of the new Tsegardex vaccine as being comparable to those of a similar American drug manufactured by MSD (U.S.A.) registered in the Russian Federation.\n\nTsegardex was also compared with the American-made vaccine as part of Phase III clinical trials in 2023. The study was conducted on healthy and previously unvaccinated adults aged 18 to 45. \n\nBoth vaccines demonstrated a high tolerance and safety profile in the study, with the reactions observed mainly represented by local reactions at the site of vaccine administration. The Tsegardex and MSD vaccines are comparable in terms of safety and immunogenicity.\n\nThe multicenter study was conducted at several clinical hubs: the Kirov State Medical University, the Eco-Safety Research Center in St. Petersburg, the E.A. Wagner Perm State Medical University, as well as Medical and Hygiene Unit No. 163 of the Federal Medical and Biological Agency. \n\nPhase III clinical trials on adolescents aged 9-17 are planned in 2024. \n\nThe new vaccine, Tsegardex, is expected to enter the Russian market in 2025.","image":"https://content-nanolek.ru/uploads/Rituksimab_5696cf8306.jpg","link":"/en/news/companynews/Russian-HPV-Vaccine-Successfully-Passes-Phase-III-Clinical-Trials/","strapi":true,"compare_date":"2023-11-16T21:00:00.000Z"},{"title":"Nanolek Invests RUB 5 billion in the Production of Russian Vaccines","tag":null,"source":null,"date":"31.10.2023","content":"**On October 31, 2023,** Kirov Oblast Governor Alexander Sokolov paid a working visit to Nanolek's biotechnology facilities in the Oritchevsky district of Kirov Oblast.\nDuring the working visit, the Kirov Oblast Governor Alexander Sokolov and Nanolek CEO Vladimir Nesterenko signed a number of landmark cooperation agreements, including an agreement of intent to carry out a RUB 5 billion investment project for the production of biotech drugs and state-of-the-art vaccines at Nanolek biomedical complex and a roadmap for the development of social infrastructure in the Orichevsk district of Kirov Oblast.\n\nThe event was also attended by Mikhail Sandalov, Deputy Chairman of the Government of Kirov Oblast, and Alexander Darensky, Acting Minister of Industry, Entrepreneurship and Trade of Kirov Oblast.\n\nNanolek and the authorities of Kirov Oblast are working together to improve the investment climate and develop priority areas for the region, including the biotech industry, special economic zone, transportation infrastructure, education, social welfare and employment.\n\n**Agreement of intent to carry out the investment project**\n\n\"Nanolek plans to carry out an investment project under which it will build new facilities for the production of biotech drugs and vaccines to prevent major diseases. More specifically, under the investment project Nanolek plans to manufacture its vaccine against human papillomavirus, the varicella vaccine, the meningococcal vaccine and other vaccines that prevent major diseases.\nThe project will be carried out at the Nanolek biotechnological complex in Lyovintsy, Orichevsk district, Kirov Oblast.\n\nThe company plans to carry out the investment project over a period of 7 years, from 2025 to 2032. Nanolek will produce an additional 14 million packs of drugs per year and create 280 new jobs.\n\nRUB 5 billion will be invested in the project. Tax payments over ten years of drug production at the new facilities will total about RUB 4 billion. \n\nIn 2011-2023, Nanolek's investments in its biomedical complex in Kirov Oblast totalled more than RUB 12 billion, with tax payments amounting to RUB 2 billion.\n\n**Roadmap for the development of social infrastructure in the Orichevsk district of Kirov Oblast**\n\nUnder the roadmap signed by the parties for the joint development of social infrastructure in Lyovintsy, the Orichevsk district, Kirov Oblast, where the Nanolek plant is located, joint work is planned to support a kindergarten and school under the Kirov Oblast state program \"Development of education\", as well as Nanolek’s involvement in work to enhance the urban environment in the Orichevsk district and improve public transport infrastructure by extending bus routes and creating an additional bus stop.\n\n\"Nanolek has been supporting the Orichevsky district in various ways since 2011, when the construction of the company's plant began.\n\n\"In any collaboration, be it public or private, it's a win-win situation. First of all, the people who work at the company live in Kirov, the Orichevsk district or Lyovintsy, and we have signed a dual agreement about exactly that – about the people. Under the agreement we will jointly create social infrastructure, including in relation to education, culture, and housing. We see that the plant is growing fast, production volumes are increasing, and they have occupied a unique niche. Attracting human resources is the number one problem now in Russia. Our colleagues from Nanolek are well aware of this and are searching for solutions. Together we are developing a project to build infrastructure for the people who live here and attract quality human resources via favorable economic conditions,\" said **Alexander Sokolov, Governor of Kirov Oblast.**\n\nThe CEO of Nanolek Vladimir Nesterenko said, \"The partnership between Nanolek and Kirov Oblast began when plans for the construction of the plant were confirmed in 2010, and we have continued to work together to this day. By contributing to the development of the region, we achieve synergy and foster mutual development in various fields. Let me give you an example. Despite the fluid situation regarding the import of foreign parts, Nanolek has sourced partners in the small business segment of Kirov Oblast. In the first 9 months of 2023, the company saved around RUB 50 million by working with local engineering companies and manufacturers of spare parts. I would like to note that parts from Kirov manufacturers have been approved by global quality assurance organizations for use in the production of drugs of Nanolek's partners – international pharmaceutical companies – at our plant in Kirov Oblast. This is testament to the quality of the engineering industry in the region.\n\nSpeaking about human resources, I would like to note that the company not only undertakes infrastructure projects in surrounding areas, but also collaborates with Vyatka State University, the region’s main university in the region with great scientific and educational potential.\n\nSuch multilateral cooperation in various fields helps Nanolek find solutions to HR problems, manufacture new drugs and grow as a company, and this has contributed to the development of the biotech industry in Kirov Oblast\".\n\n**About Nanolek:**\nNanolek is a modern biopharmaceutical company founded in 2011. It specializes in the production of import-substituting and innovative drugs. It is a leader in the production of pediatric vaccines in the Russian Federation. In addition to vaccines, the company's portfolio includes drugs for the treatment of oncological diseases.","image":"https://content-nanolek.ru/uploads/news20231109_a741b1a512.jpg","link":"/en/news/companynews/Nanolek-Invests-RUB-5-billion-in-the-Production-of-Russian-Vaccines/","strapi":true,"compare_date":"2023-10-30T21:00:00.000Z"},{"title":"Nanolek Top Manager Enters Top 1000 Russian Managers Rating","tag":null,"source":null,"date":"27.09.2023","content":"**September 27, 2023, Moscow.** _Deputy General Director for Operational Issues and Interaction with Nanolek Partners Denis Dugin has entered the prestigious ranks of the Top 1000 Russian Managers list. The results of the rating were published in \"Kommersant\" on September 27._\n \nThe ranking has been carried out by the publisher \"Kommersant\" with the Russian Managers Association since 2001. At the end of every year, the rating identifies the best managers in various sectors of the economy, focusing on the experts themselves, that is, the representatives of assorted industries and areas of activity.\n\nDenis Dugin, Deputy General Director for Operational Issues and Interaction with Nanolek Partners, made it into the category Top 25 best logistics and supply chain directors, occupying first place among directors for logistics and supply chains in the pharmaceutical industry for 2022. \n\nDenis ensured performance over and above the target for the annual production and sales plan, overseeing the absence of production downtime due to raw material and item shortages by effectively aligning key sales and planning divisions within the company.\n\nCooperation and work with Nanolek's partners have been rebuilt via contract production to improve efficiency thanks to Denis. The OTIF (on time in full) service metric increased from 87% in 2021 to 99% in 2022 as a result.\n\n_\"Nanolek executives are included in the Top 1000 Russian Managers rating every year. The success of a business and its ability to develop under changing economic conditions are directly dependent upon the skills of its management team. Over the past year, the pharmaceutical industry has faced both logistical and procurement hurdles. Nanolek is able to cope with these changes due to the work by Denis Dugin and his team. What is valuable is that the professionalism of the Nanolek team is being highlighted by industry experts,\"_ Nanolek CEO Vladimir Nesterenko commented on the results of the rating.\n\n","image":"https://content-nanolek.ru/uploads/news_27_09_2023_3c52025000.jpg","link":"/en/news/companynews/Nanolek-Top-Manager-Enters-Top-1000-Russian-Managers-Rating/","strapi":true,"compare_date":"2023-09-26T21:00:00.000Z"},{"title":"Vademecum: \"Nanolek Already Achieved Sustainable Development Under Khristenko.\" Where's the Vaccine Manufacturer Headed After Founder's Departure?","tag":null,"source":null,"date":"14.06.2023","content":"_By Dmitry Kryazhev_\n\nLast year Vladimir Khristenko vacated the post of president and gave up his equity stake in Nanolek. The company decided on a new direction in May of this year, when legendary pharmaceutical industry manager Vladimir Nesterenko took up the mantle of CEO of the company. He spoke about his vision of the past and future of the immunobiological market as well as Nanolek's plans in an interview with Dmitry Kryazhev, publisher of Vademecum.\n\n**– There have been many interesting cases in your career. You've managed retail, distribution, and manufacturing companies, and were even a civil servant. And you were particularly involved in the creation of Microgen 20 years ago. That is to say, you were part of the very foundation of the immunobiological market that grew out of that reform. What kind of industry developments were seen back then?**\n\n– The early 2000s was a time when the state was able to turn its attention back to restoring the country's immunobiological security system. At that time there were 13 businesses with corresponding portfolios scattered around Russia, all operating independent of one another. And while they were all state-owned, there was very little order in their activities. Most of the sites were old, some I'd say, were even ancient factories. Production facilities and equipment were on their last legs. At the time, both the government and the Russian Health Ministry believed that the only way to solve the issue of reviving domestic immunobiology was by combining all these assets into a single state-owned company. This process, however, wasn't exactly linear due to the extraordinary times we were living in. The enterprises were, as they used to say, managed by \"red\" directors who had grown into them and thought of these enterprises as their personal property rather than being owned by the state. Each one of these bosses needed to be negotiated with individually. Some immediately snapped a salute and backed the idea, while others caused chaos and disturbance among their work teams, spreading rumors about the privatization or closure of the plants, etc. But finally, despite all of the difficulties we encountered, we were able to bring this plan to fruition.\n\n**– As far as I recall, the creation of Microgen was overseen by then Deputy Health Minister Anton Katlinsky.**\n\n– Yes, Anton Vikentievich. He won the competition to head Microgen soon after the arrival of the new government and new leadership coming to power in the Ministry of Health. He held the post for five years. It was actually during this period that the industry configuration we are witnessing now was formed. A single state-owned enterprise, a transparent system for unified state procurements for immunobiological products was formed, and a National Immunization Calendar (NIC) was created.\n\n**– For most of the early 2000s the vaccine market itself (mainly the NIC) was conservative, if not to say uneventful, especially against the backdrop of the launch of the Supplemental Drug Coverage (SDC) program. The latter rapidly reprogrammed the entire state order in pharma and greatly influenced the development of the healthcare system in Russia.**\n\n– There are several explanations for that as well. First off, the SDC itself took over a significant portion of the healthcare budget. Second, the peculiarities of the legislation regarding unitary state enterprises, meant that the development of Microgen, wouldn't be rapid. The profitability of the assortment back then was rather low. It was nearly impossible for a state-owned enterprise to get money from a bank for re-equipment purposes and organizing developments. Looking in from the outside, the situation had already changed for the better in the next decade, when Microgen entered into the fringes of Nacimbio. Third, the very idea of immunobiological safety is something that doesn’t need any commotion. It's also important to note that private companies, both Russian and foreign, have quietly developed and are developing on the market. A commercial vaccine market has formed alongside that of the state market, and believe me, it's very far from being saturated. The first private domestic company, Petrovax, has seen decent growth. And later that very same Anton V. Katlinsky built a modern vaccine production plant called Fort near Ryazan, then there was the appearance and development of Nanolek. And the COVID-19 pandemic has since become a trigger for domestic pharmaceutical companies to direct efforts towards vaccines.\n\n**– That's all true. But improving the NIC, that is, the creation of new market is a tricky topic in itself. Let's recall Pfizer's breakthrough with a pneumococcal vaccine in the calendar. Very soon it will be ten years since this event occurred. It generated enormous interest in the market, particularly by Big Pharma companies. Over the years their lobbyists have argued vociferously, yet such prevention items as human papillomavirus (HPV), rotavirus, and meningococcal infections are still on the waiting list.**\n\n– There are several factors involved here. The NIC isn't only a guaranteed market for sales, but the most massive in terms of state procurements. Each and every vaccine campaign means the release of hundreds of thousands, even millions of doses of vaccines. It's evident that the state, as both a customer and guarantor of the nation's welfare, needs certain guarantees from the manufacturer, wants to see comprehensive localization of the product. And a total technology transfer, especially in such a sensitive area as immunobiology, is a very challenging task. The global vaccine manufacturers didn't take a stab at building full-cycle plants, and the number of Russian partners capable of localization can be counted on the fingers of one hand, as mentioned above. Nanolek's experience in localizing Pentaxim speaks volumes about what a complex, long, and time-consuming this process is. How much due diligence the company has had to go through! Our partners are scrupulous in their study of compliance with the tech cycle, transportation, and storage conditions. That's why it's important to note that the NIC is not a closed market, but it will always be a reasonably conservative one, and will impose a host of conditions on applicants for inclusion in the calendar, no matter whether we're talking about a domestic or foreign manufacturer.\n\n**– By the way, how are relations with foreign partners developing at present?**\n\n- All of the projects that have been started are still ongoing. In particular, the localization of the release of a meningococcal vaccine is in full swing. We hope that all the conditions for it to be included in the NIC will be met by 2025. And it's clear to us that the calendar will develop and the market will grow, again, simply due to the shift in healthcare focus from treatment to disease prevention. And the more developed and competent local producers are, the more flexible the system for access of their products to the guaranteed and mass market will become. We can once again turn to Nanolek, where an HPV vaccine is also on its way to being registered. This time it is part of our collaborative effort with Combiotech, a research and production company. When making an investment in Combiotech, the company doesn't look back and wonder if there will be a \"empty spot\" for it in the calendar. There is a global trend and we're part of it. This development, moreover, opens up export opportunities for Nanolek as well. There aren't many manufacturers on the HPV market. Several countries in Southeast Asia and the Commonwealth of Independent States have already taken an interest in our product. I think our suggested price will be more competitive than that of global manufacturers.\n \n**– And what areas do you plan to develop for the domestic market?**\n\n– We want to become an active player on the adult vaccine market. We're now actively studying this area, trying to grasp which products will be in demand.\n\n**– But this isn't the NIC. You're talking about the purely commercial market now where there are different laws of demand.**\n\n– Of course. That's why we're taking a careful look at it. We're balancing our capabilities against the needs of healthcare.\n\n**– Veterinary medicine is also a very receptive and interesting market.**\n\n– Absolutely. The vaccine market in animal husbandry alone is 30 billion rubles annually. But entry into this market will require large-scale investments and the construction of a separate new enterprise next to the existing one. First and foremost, it's important to understand who we can work with as partners to enter this high-capacity niche, whose expertise we can rely on.\n\n**– Let's jump back to the present. You've been working at Nanolek for less than a month, but you've probably got on the ball already. What's your overall impression?**\n\n– Well, you know about my diverse managerial experience. And with this in mind, I can say that I was surprised to learn what a nice and first-rate company founders Vladimir Khristenko and Mikhail Nekrasov were capable to build. Mr. Khristenko was responsible for development, strategy, and partnerships, while Mr. Nekrasov was in charge of production. Competent management, an excellent plant in Kirov, whose creation laid the foundation for further development of capacities, and a professional, motivated staff at the enterprise. In fact, Nanolek already achieved sustainable growth under Khristenko. The days of the company's formation are long gone.\n\n**– If I remember correctly, Nanolek reached its planned profit by the end of 2021. And around the same time there was information that Khristenko wanted to quit as one of the founders and was considering buyers to take over his shares.**\n\n– The reasoning behind it was purely business-related and Khristenko's decision to sell his stake in the firm had nothing to do with the risk of sanctions. When I joined Nanolek, I familiarized myself with the company's paperwork. The company left the investment phase in 2019, which is quite quick for this niche market. This cycle usually takes 8 to 10 years for vaccine manufacturers. The consistent growth of revenue and profit has begun. Vladimir began negotiating the sale of his stake in 2021, and in 2022 he sold it to both partners and management. He then handed over his workload to vacate the post of president by the end of last year.\n\n**– So you haven't crossed paths with him yet?**\n\n— No. He has nothing to do with either Nanolek or the Russian pharmaceutical business as a whole now.\n\n**– As we've already touched upon, you've had several interesting cases in your career. The most memorable for me personally was the relaunch of the wholesaler GDP as part of the 36.6 Group as a distributor on the state procurement market. It turned out to be an interesting story. Is it possible to create something similar with Nanolek?**\n\n– We work as a distributor for a number of high-tech products, mainly those whose secondary packaging we localize at the Kirov plant. This brings the company a nice sum in terms of additional revenue. Obviously, there's more to be done in this direction, we could strengthen it. But this isn't of paramount importance. The production of vaccines will remain our primary focus. There will be a lot of work to expand our portfolio.\n\nSource: [Vademecum](https://vademec.ru/article/pri_khristenko_-nanolek-_uzhe_prishel_k_ustoychivomu_razvitiyu/)\n\n","image":"https://content-nanolek.ru/uploads/zavod_na_sajt_1ff4d61f7c.jpg","link":"/en/news/companynews/Vademecum-Nanolek-Already-Achieved-Sustainable-Development-Under-Khristenko.-Where's-the-Vaccine-Manufacturer-Headed-After-Founder's-Departure/","strapi":true,"compare_date":"2023-06-13T21:00:00.000Z"},{"title":"Russian Vaccine Manufacturer Nanolek changes its jurisdiction from Cyprus to Russia","tag":null,"source":null,"date":"06.06.2023","content":"**BFM.ru, 06.06.23**\n\n_The deal was closed at the end of May. Nanolek's previous owner was the Cyprus-based Nanolek Holding Limited, and since April 28 it has been the investment fund Management-Aktiv managed by the K2 Group._\n\nK2 Group Management Company owned by Anton Pak, chairman of the board of the pharmaceutical manufacturer, is a new owner of Nanolek Vaccine Manufacturer. Earlier Nanolek was owned by the Cyprus-based Nanolek Holding Limited, according to [\"Vedomosti\"](https://nanolek.ru/en/news/companynews/Owners-of-Vaccine-Manufacturer-Nanolek-Change-Cyprus-Registration-to-Russia/).\n\nThe change of jurisdiction occurs in the background of new regulatory requirements in place for Russian business. Last year, Vladimir Khristenko, the son of former Deputy Prime Minister Viktor Khristenko, ex-President of Nanolek, left the co-ownership; however in February 2023 he was be slapped with Canadian sanctions anyway.\n\nCyprus imposed a number of restrictions against Russia, so the transition to Russian jurisdiction over the past year has become a trend for pharmaceutical companies. Russia has created special economic zones with comparable conditions, according to **Nikolay Bespalov, Development Director of RNC Pharma analyst company**:\n— Nanolek is quite a large manufacturer; now they have a serious interest in developing the vaccine-related portfolio. They also develop their own vaccine portfolio, as well as cooperate with foreign partners, for whom they provide the service of contract manufacturing of these drugs in Russia; there are rather large partners among them. So this is a very significant player in the Russian market with very big ambitions.\n\n**— What were the most notable changes in the Russian pharmaceutical market over the past year or year and a half?**\n— First, we had to tackle problems related to logistics. Many Russian companies were forced to look for new partners in terms of supply of raw materials and some auxiliary products needed for production, as well as in terms of equipment. It was a huge job that has been done last year. Second, priorities of foreign companies in the market have changed dramatically, partly due to sanctions restrictions and partly due to economic processes. A lot of foreign companies have suspended supplies of their products to Russia due to the fact that the sale of certain foreign-made drugs in Russia has become unprofitable. Most often this is due to increased competition from domestic manufacturers. Therefore, the companies have cleaned up their product portfolios in a very active way. All these processes, on the one hand, were the challenges for Russian manufacturers, on the other hand, provided some unique opportunities as they gave impetus to the development of their own competencies, opened up new competitive niches and enabled them to occupy these niches. Probably these are the most important things that actually happened last year.\n\nIn the context of growing prices for pharmaceutical raw materials, exchange rate fluctuations and cost-intensive logistics, supplies of these drugs from the list of vital and essential medicines to the market have become unprofitable for domestic drug-producing companies, says Sergey Kolesnikov, President of the Association of Pharmaceutical and Medical Product Manufacturers, Member of the Russian Academy of Sciences:\n\n**Sergey Kolesnikov, President of the Association of Pharmaceutical and Medical Product Manufacturers, Member of the Russian Academy of Sciences**, “The growth of prices for vital and essential drugs has not been stopped, and the growth of prices for foreign drugs is not controlled, so the prices have increased two or three times. And the prices for vital and essential drugs have gone up even more, which causes them to leave the market. Who benefits from this? No one. The Government says that it protects patients. No, it protects foreign Big Pharma companies that come in and replace our medicines. So we have to wonder whether our market will develop after such measures or not. Agriculture and production of medicines ensure a gain in industrial output and, consequently, in gross domestic product. All other sectors, except defense, are down”.\n\nLater Business FM editorial office received a comment from the Company, “In 2022, co-founder, president and ideologist of the Company Vladimir Khristenko sold his share in Nanolek to partners and management and resigned as president. In parallel, work has been underway to significantly simplify the management structure with a new set of shareholders. And these changes were reflected in the register in May 2023. Previously, the founder of Nanolek LLC was Nanolek Holding Limited incorporated in Cyprus. According to new regulatory requirements applicable for Russian business, the old management structure was no longer relevant, and this was the reason behind the changes that took place. This change will have not have any influence on the logistics of drugs and raw materials supply. The prices will not be affected as well, they are determined by the state, and we are dealing with government procurement contracts. The tax burden will also not change. We work as usual, all our partners stand by their commitments; the logistics tasks have undoubtedly become more difficult, but we understand our responsibility and continue to work. These are the challenges, which we successfully cope with.”\n\nIn addition to vaccines, Nanolek produces cancer drugs, antivirals, ARVs, and other groups. Last year the Company’s revenue was 19 billion rubles, net profit amounted to 2.5 billion rubles.\n\n[Source](https://nanolek.ru/news/companynews/Business-FM-Rossiiskii-proizvoditel-vaktsin-Nanolek-smenil-yurisdiktsiyu-s-Kipra-na-RF/).\n","image":"https://content-nanolek.ru/uploads/4_vot_etot_fajl_13428ef315.jpg","link":"/en/news/companynews/Russian-Vaccine-Manufacturer-Nanolek-changes-its-jurisdiction-from-Cyprus-to-Russia/","strapi":true,"compare_date":"2023-06-05T21:00:00.000Z"},{"title":"New Shareholder Structure Enters Into Force at Nanolek ","tag":null,"source":null,"date":"05.06.2023","content":"June 5, 2023, Moscow. Today, in a comment to \"Vedomosti\", Nanolek publicly [confirmed](https://www.vedomosti.ru/business/articles/2023/06/05/978584-vladeltsi-proizvoditelya-nanolek-pereregistrirovali-kompaniyu-s-kipra-v-rossiyu) that one of its co-founders, Vladimir Khristenko, sold his shares in the company to partners and management as far back as last year. In parallel, work has been underway on a new management structure for the company aimed at ridding it of its Cypriot \"registration\". \n\nNanolek was founded in 2011 by Mikhail Nekrasov, a doctor, scientist, and entrepreneur in the field of biotechnology. Vladimir Khristenko [joined](https://www.rbc.ru/economics/22/02/2013/570403ec9a7947fcbd445fd0) him as a shareholder and manager in 2013. The company produces pediatric vaccines, cancer drugs, and medicines for orphan (rare) diseases at its plant in the Kirov Region. \n\nIn December 2022, Vladimir Khristenko [vacated](https://www.forbes.ru/biznes/483310-soosnovatel-proizvoditela-vakciny-kovivak-usel-s-posta-prezidenta-kompanii) the post of company president, and today, on 5 June, Nanolek's press service first confirmed to \"Vedomosti\" that last year he also gave up being a shareholder, selling his shares to partners and management. \n\nOn May 16, 2023 Vladimir Nesterenko was appointed as the new CEO, replacing company co-founder Mikhail Nekrasov. Meanwhile, on May 24 a deal was struck making K2 Group (owned by Anton Pak who has headed the company's board of directors for several years) the new owner of Nanolek. Nanolek's previous owner was the Cyprus-based Nanolek Holding Limited, and since April 28 it has been the investment fund Management Asset (also managed by K2 Group). \n\n\"In 2022, Vladimir Khristenko ceased being a Nanolek shareholder and also vacated the post of president. In parallel with this, work was also done to substantially simplify the management structure, with a new composition of shareholders,\" Nanolek's press service explains. \"And these changes were reflected in the register in May 2023. The founder of Nanolek LLC was previously Nanolek Holding Limited incorporated in Cyprus. We'd like to recall that Nanolek was originally an entirely Russian company, but like many other participants on the Russian market, were based in Cyprus to facilitate cooperation with international partners (Cyprus is under the jurisdiction of British law). According to new regulatory requirements in place for Russian businesses, the old management structure was no longer relevant, and this was the reason behind the changes that took place\". \n \nAbout Nanolek:\nNanolek is a modern biopharmaceutical company, one of the leaders in the production of pediatric vaccines in Russia. It was founded in 2011. The Nanolek plant in the Kirov Region specializes in the production of import-substituting and innovative drugs, both of its own design and developed with the involvement of international partners. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases. \n","image":"https://content-nanolek.ru/uploads/zavod_na_sajt_1ff4d61f7c.jpg","link":"/en/news/companynews/New-Shareholder-Structure-Enters-Into-Force-at-Nanolek--/","strapi":true,"compare_date":"2023-06-04T21:00:00.000Z"},{"title":"Owners of Vaccine Manufacturer Nanolek Change Cyprus Registration to Russia","tag":null,"source":null,"date":"04.06.2023","content":"_The previous ownership structure is no longer relevant after the sanctions._\n\n**By Anastasiya Kovaleva, Vedomosti, 04.06.23**\n\nK2 Group Management Company owned by Anton Pak, chairman of the board of the pharmaceutical manufacturer, became the new owner of Nanolek. According to SPARK-Interfax, the deal was closed on May 24. Previously, Nanolek was owned by the Cyprus-based Nanolek Holding Limited, and since April 28 it has been the investment fund Management-Aktiv (also managed by the K2 Group Management Company).\n\n“The late changes were connected with new regulatory requirements in place for Russian business,” says Nanolek’s representative. According to him, the old ownership structure is no longer relevant in current conditions. He did not give other details.\n\nNanolek was founded in 2011 by Vladimir Khristenko, the son of former Deputy Prime Minister Viktor Khristenko, and Mikhail Nekrasov, a former deputy of the Kirov Oblast Legislative Assembly. The Nanolek plant in the Kirov Region produces vaccines, cancer drugs, drugs for orphan diseases, etc. Nanolek Holding Limited is believed to have been controlled by Mr. Khristenko, Mr. Nekrasov, and their partners Evgeny Weinstein and Andrey Reus since 2019. In 2022, Vladimir Khristenko ceased being a Company shareholder and later also vacated the post of president. He transferred his share to partners and management, as “Vedomosti” was told by the Company. And in February 2023, Mr. Khristenko, along with his father Victor and his wife, Deputy Prime Minister Tatyana Golikova, were included in the Canada’s sanctions list.\n\nCurrently, Cyprus is a country that has taken unfriendly actions against Russia, which is why there are a number of restrictions for local companies: they can not fully participate in the activities of legal entities in our country as shareholders, they are limited in obtaining profits, explained Ekaterina Orlova, head of the legal firm Grace Consulting Ltd. This view is also shared by Natalia Abtseshko, head of the International Project Team at Vegas Lex, saying that Russian business, which is partially owned by foreign shareholders, is now experiencing a number of difficulties, e.g. as far as the cooperation between the parent company and subsidiary in the supply of goods and services is concerned.\n\nAccording to Mrs. Abtseshko, difficulties also arise when solving corporate issues, for example, there are restrictions from the perspective of EU legislation on the provision of certain services to Russian businesses, as well as bans prohibiting Europeans to hold certain positions in some Russian companies and preventing Russians to hold offices in European firms. As a result, corporate structures which were previously widespread lose their relevance, especially for companies with originally Russian beneficiaries, the expert summarizes.\n\nThe General Director of DSM Group Sergei Shulyak also notes that lately sale of companies to management has become more common. This is a standard practice for businesses to circumvent the risk of sanctions. For example, in mid-May, Murat Aliyev’s Bonum Investments (ex-CEO of Suleiman Kerimov’s Nafta Moscow financial-industrial group) assigned 49% of shares in Pascal Medical (which produces disposable medical syringes) to Maxim Sarmanov, the Company’s General Director. In late 2022, the U.S. Treasury Department imposed sanctions on Aliyev, Bonum Capital and related entities.\n\n[Source](https://www.vedomosti.ru/business/articles/2023/06/05/978584-vladeltsi-proizvoditelya-nanolek-pereregistrirovali-kompaniyu-s-kipra-v-rossiyu).\n","image":"https://content-nanolek.ru/uploads/4_vot_etot_fajl_5f9d05eab6.jpg","link":"/en/news/companynews/Owners-of-Vaccine-Manufacturer-Nanolek-Change-Cyprus-Registration-to-Russia/","strapi":true,"compare_date":"2023-06-03T21:00:00.000Z"},{"title":"Vladimir Nesterenko to Head Nanolek","tag":null,"source":null,"date":"16.05.2023","content":"May 16, 2022 Vladimir Nesterenko, a well-known manager in the pharmaceutical industry, is to become the new CEO of Nanolek. Co-founder and former head Mikhail Nekrasov has decided to leave his position to focus on scientific activities.\n \n_\"The company Nanolek that I have been entrusted to manage, isn't only a well-formed portfolio of medications to treat socially significant diseases, thereby ensuring sustainable growth for the firm, but also one of the best teams on the Russian pharmaceutical market. I'm confident that the infrastructure built over the years the company has been in operation will allow us to implement a successful development strategy that takes into account new regulatory trends and changing market realities,\" Vladimir Nesterenko said about his appointment._\n \nVladimir Nesterenko possesses a wealth of managerial experience in the pharmaceutical industry. He began his professional career as a critical care doctor (anesthesiologist) and has a PhD in medicine. He has held senior positions in manufacturing and distribution companies, as well as in retail pharmacy. From 2018 to 2020 he was the CEO of the pharmacy chain 36.6 PJSC, and put in place a new anti-crisis strategy for the company's development during this period. Since 2020 he has been CEO and then owner of 36.6's distribution division, GGP, which in just three years entered the top 10 suppliers in terms of the industry's budget sector. At Nanolek Vladimir Nesterenko plans to maintain and strengthen its system of partnerships with both international and Russian companies, moving towards the goal of becoming a market leader for pediatric vaccines.\n \n_\"I have long had a dream to develop a drug to treat cancer that involves AI. This is in the area of fundamental science, while at Nanolek we were involved in applied projects with a significantly shorter time to market. There is absolutely no time for scientific activity within a real business setting. I also want to change my pace of work to something calmer to spend more time with my family and pay attention to my own needs,\" said Mikhail Nekrasov, one of the pioneers of the new Russian pharma, a doctor by profession and CEO of Nanolek from 2011 to 2023 about his resignation. \"I'm leaving the company in safe hands and in stable condition.\"_\n \nIn 2022 the Nanolek team indeed managed to stay at the level of the previous year and practically maintain turnover, fulfill all of its contracts on time and launch all planned products, despite the break in supply chains and supply difficulties. Nanolek's clear focus on strategic projects, pediatric vaccines, helped maintain stability in the business.\n \n Reference:\nNanolek is a modern biopharmaceutical company founded in 2011. It specializes in the production of import-substituting and innovative medicines. The firm is one of the leading producers of pediatric vaccines in Russia. In addition to vaccines, its portfolio includes medications to treat oncological and orphan (rare) diseases.\n","image":"https://content-nanolek.ru/uploads/4_vot_etot_fajl_52ec26e8ed.jpg","link":"/en/news/companynews/Vladimir-Nesterenko-to-Head-Nanolek/","strapi":true,"compare_date":"2023-05-15T21:00:00.000Z"},{"title":"Nanolek Presents New Domestic 13-Valent Pneumococcal Vaccine ","tag":null,"source":null,"date":"21.02.2023","content":"_Moscow, March 21, 2023. The Russian biopharmaceutical company Nanolek has presented the results of clinical trials for a domestic vaccine to prevent pneumococcal infections. Full-cycle production of it is planned at a plant in the Kirov Region. [Clinical studies](https://www.epidemvac.ru/jour/article/view/1676/0) have shown that the vaccine possesses a favorable safety profile and have proven its immunogenicity._\n\nPneumococcal infections caused by Streptococcus pneumoniae bacteria are a significant problem for healthcare because of the pathogen's high pathogenicity and the potential for a severe course of the disease with complications leading to disability and death in young children. According to the World Health Organization and the Russian Ministry of Health, pneumococcus more often than other infections leads to pneumonia and bacterial otitis media in children under the age of 5, and infants most often die from diseases caused by this infection. Pneumococcus is additionally considered one of the causes of sinusitis and bacterial meningitis, and can also lead to sepsis.\n\nSeveral years ago Nanolek took up the development of a vaccine against pneumococcal infections alongside a Korean company specializing in the production of vaccines. The production of a new domestic pneumococcal polysaccharide conjugate vaccine (thirteen-valent, adsorbed) has been launched at a Nanolek plant in the Kirov Region. Production is carried out according to GMP (Good Manufacturing Practice) and ISO (International Organization for Standardization) standards. \n\nThe new 13-valent pneumococcal conjugate vaccine has been registered in the Russian Federation under the commercial name PNEMOTEX® and can be used in adults and children from 2 months of age and older (registration certificate number LP-007205). Based upon compliance with the rules determining the interchangeability of medicinal products for medical use, approved by decree N 1360 of the Government of the Russian Federation dated September 5, 2020, the status of interchangeable reference medicinal products for the vaccine PNEMOTEX® and the vaccine Prevenar® 13, Pfizer Inc., ([registration number LP-000798](https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=4cd022c3-76e4-4ad0-acd0-4f5c7a3fd231)) was obtained. Information concerning the former was entered on the website of the State Register of Medicines (GRLS) in the updated list of interchangeable drugs dated November 7, 2022, Appendix No. 1. \n\nPhase 3 clinical trials have been completed on the drug, with their results discussed by leading experts in the field of vaccines at a scientific conference organized by Nanolek. The event was moderated by **Leyla Namazova-Baranova**, MD, professor, member of the Russian Academy of Sciences, chief freelance children's specialist in preventive medicine at the Russian Ministry of Health, and president of the Union of Pediatricians of Russia. \n\n**Nikolai Briko**, honored scientist of the Russian Federation, member of the Russian Academy of Sciences, MD, professor, director of the F.F. Erisman Institute of Public Health, and head of the Department of Epidemiology and Evidence-Based Medicine, spoke about topical issues regarding pneumococcal infections. Particularly about insufficient detection, the issue of antibiotic resistance, parents' refusal to vaccinate or failure to comply with recommended immunization regimens. Nikolai Ivanovich noted that in a number of regions there is insufficient vaccination coverage of children to form population immunity and control over diseases associated with Streptococcus pneumoniae. It is necessary to adhere to the start of immunization of children against pneumococcal infections and the recommended 2 + 1 vaccination schedule in a timely manner.\n\n**Susanna Harit **(head of the Department for the Prevention of Infectious Diseases, FSBI \"Children's Scientific and Clinical Center for Infectious Diseases\" at the Federal Medical-Biological Agency of Russia, MD, and professor) in her speech focused on Phase 3 clinical trials of a new vaccine for adults and children conducted in Korea. PCV13 has been shown to be no less effective than PPV23 in adults, with comparable rates of adverse events between groups. PCV13 proved to be no less effective than the reference vaccine in terms of results in a Phase 3 study in children, with comparable immunogenicity and activity concerning the formation of functional antibodies. The safety parameters of the vaccines were also similar.\n\n**Irina Feldblum** (MD, professor, head of the Department of Epidemiology at Academician E.A. Wagner Perm State Medical University of the Russian Ministry of Health) spoke about the results obtained in Phase 3 clinical studies involving adults in Russia. Volunteers aged 18 to 65 who had not previously received a pneumococcal vaccine were selected for a prospective comparative randomized double-blind study. The study proved no less immunological efficacy for PCV13 when compared to the reference vaccine in terms of the primary criterion - the proportion of participants with a concentration of lgG ≥ 0.35 μg/ml for each serotype, as well as the secondary criteria, immunogenicity. Safety in both groups was comparable.\n\n**Olga Rychkova** (MD, professor, head of the Department of Infectious Diseases, Allergology, and Immunology at Tyumen State Medical University of the Russian Ministry of Health, chief allergist-immunologist at the Tyumen Region Health Department) spoke about the results of a Phase 3 clinical study among children. Olga Rychkova reported that the study in children consisted of two stages: primary double vaccination of children ages 2 and 4.5 months and revaccination at 15 months of age. The results of the study showed that the immunization of children with pneumococcal vaccines per the 2 + 1 schedule regulated by the Russian National Immunization Calendar allows the necessary immune response to be achieved. The pneumococcal polysaccharide conjugate vaccine (thirteen-valent, adsorbed) demonstrated no less immunogenicity for all 13 serotypes when compared to the reference vaccine according to both the primary and secondary criteria for assessing immunogenicity. As per the results of the Phase 3 study in children, the new PCV13 has a high safety profile versus the comparison drug. This study proved the immunological efficacy and safety of the new PCV13 for the prevention of pneumococcal diseases in children ages 2 months and older. \n\n_\"Nanolek is ready to supply the vaccine to the National Immunization Calendar, it will be available to citizens of the Russian Federation free of charge. The vaccine's availability will ensure the stability of supplies and the state's confidence that the people of Russia will be provided with the drug,\" said Nanolek First Deputy General Director** Maxim Stetsyuk**. _\n\nVaccination against pneumococcal infections has been part of the National Immunization Calendar (NIC) in Russia since 2014. Children ages 2, 4.5, and 15 months are vaccinated with it. Vaccination against pneumococcal infections is also included in the Calendar of Preventive Immunization according to epidemic indications for children 2 to 5 years of age and at-risk adults. Today, vaccination against pneumococcal infections is part of the national immunization programs of [168 countries around the world](https://view-hub.org/vaccine/pcv?set=current-vaccine-intro-status&group=vaccine-introduction&category=pcv). An Italian study conducted among 6,680 people [shows](https://pubmed.ncbi.nlm.nih.gov/32842505/) the percentage of cases of COVID-19 is significantly lower among individuals of different ages vaccinated against pneumococcal infections and influenza.\n\nReference: \n\nNanolek is a modern biopharmaceutical company founded in 2011. It specializes in the production of import-substituting and innovative medicines. The firm is one of the leading producers of pediatric vaccines in Russia. In addition to vaccines, its portfolio includes medications to treat HIV, oncological and orphan (rare) diseases. \n\nBecause of the localization of the vaccines PENTAXIM® and MENACTRA®, Nanolek is the only Russian company that possesses vaccines in its portfolio of medications to prevent bacterial meningitis, most often caused by three main infections: Haemophilus influenzae type b (as part of the vaccine PENTAXIM®), meningococcal infection (as part of the tetravalent conjugate vaccine for serogroups A, C, Y, and W MENACTRA®), and pneumococcal infections (as part of a 13-valent vaccine for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14 , 18C, 19A, 19F, and 23F PNEMOTEX®).\n","image":"https://content-nanolek.ru/uploads/zavod_na_sajt_1ff4d61f7c.jpg","link":"/en/news/companynews/Nanolek-Presents-New-Domestic-13-Valent-Pneumococcal-Vaccine-/","strapi":true,"compare_date":"2023-02-20T21:00:00.000Z"},{"title":"Vladimir Khristenko resigns as President of Nanolek ","tag":null,"source":null,"date":"29.12.2022","content":"_December 29, 2022. Co-founder of Nanolek Vladimir Khristenko announced his intention to step down as President, the post he has been holding since 2015. Mr. Khristenko transferred the corporate governance of the pharmaceutical company, supplier of 25% of vaccines for the National vaccination schedule of Russia, completely to his partner Mikhail Nekrasov, General Director of Nanolek. The shareholding structure of the company will remain unchanged._\n\n\"I believe my mission has been accomplished: our company has gone a long way from a pure startup business to one of the backbone Russian biopharmaceutical companies\", said Mr. Vladimir Khristenko. „On average, 12 years is a long period of time for any Russian business, however for a pharma industry this is a very small time span. We have developed ahead of schedule, at a record pace\". And quotes the figures: the company's revenue grew from RUB 300 million in 2015 to almost RUB 20 billion 2021. In 2020, the company saw a revenue growth of 70% compared to 2019, and in 2021 — a revenue increase of + 57% versus 2020. \n\n\"Now it's time for Nanolek to switch to the next level that requires a different management approach, not the one I pursue\", emphasized Vladimir Khristenko. “I'm clearly a startup guy. I love to create something from scratch, something exposed to maximum risks, however with maximum thrill, and this is exactly my element. In recent years, I have tried to invest in a targeted way in other people's endeavours and undertakings. This is also rather interesting, but I'm perfectly aware that this is not enough for me. So, I will take a breath, reflect on what has been done and achieved so far and will in any case invent something new\".\n\nAs one of the co-founder of Nanolek, Mr. Mikhail Nekrasov will remain General Director of the company. Mr. Nekrasov, one of the pioneers of the new Russian pharma industry, a physician by his degree and a successful businessman in the field of biotechnologies, will continue the company's path of business development: now we are witnessing a lot of new growth opportunities that arise within the context of vigorous import substitution measures to be implemented at present time. During the time of its work, Nanolek has gathered a highly competitive expertise to cope with this task, while cooperating with the leading global experts in localization projects. \n\n\"Our main task for the next few years is to develop strategic partnerships with large players in the Russian market\", emphasized Mikhail Nekrasov. “Our nation sets ambitious goals to be met by the entire pharma industry: make sure that people in Russia have access to all necessary medicines and drugs used for disease prevention, and in this respect, import substitution is nowadays a top priority. However, there are also no less important things to do: we need to drive forward promising endeavours in order to create our own innovative drugs. Nonetheless, none of this could be possible without a close cooperation between the leading pharmaceutical companies: we need to go side by side and should learn to pool resources wisely\". \n \nAbout Nanolek: \nNanolek is a modern biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov, specializing in the production of import-substituting and innovative drugs. It is one of the leaders in the production of paediatric vaccines in Russia. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases.\n","image":"https://content-nanolek.ru/uploads/VV_dfc0e49c60.jpg","link":"/en/news/companynews/Vladimir-Khristenko-resigns-as-President-of-Nanolek-/","strapi":true,"compare_date":"2022-12-28T21:00:00.000Z"},{"tag":"COMPANY NEWS","title":"The Ministry of Education of the Kirov Region, Vyatka State University and Nanolek Sign a Cooperation Agreement","date":"22.03.2022","desc":"","link":"/en/news/companynews/the-ministry-of-education-of-the-kirov-region-vyatka-state-university-and-nanolek-sign-a-cooperation/","inner_date":"22.03.2022","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t 22.03.22, Kirov. The Ministry of Education of the Kirov Region, Vyatka State University and the Russian innovative biopharmaceutical company Nanolek signed a 3-party educational agreement. The parties aim to create favourable conditions for the development of school education in biopharmaceuticals in the Kirov Region.\n</p>\n<p>\n\t The issues of interaction will relate to increasing the migration attractiveness of the region and retaining talents in the Kirov Region, developing the human resources potential of biopharmaceutical industries, organizing school education and developing higher education with a specialization in pharmaceutical biotechnology, early career guidance for schoolchildren, taking into account the needs of the biotechnology industry, which is a current priority for the Kirov Region.\n</p>\n<p>\n\t The agreement was signed by the Minister of Education of the Kirov Region - Olga Nikolaevna Ryseva, the Rector of the Vyatka State University - Valentin Nikolayevich Pugach and General Director of Nanolek - Mikhail Sergeevich Nekrasov.\n</p>\n<blockquote>\n\t<p>\n\t\t The Minister of Education of the Kirov Region Olga Nikolaevna Ryseva noted that the signing of the agreement would contribute to the implementation of regional programs and events of particular social importance for the people of the Kirov Region. \"Biotechnology, innovative and promising industry is one of the key areas for the development of our region; therefore, it is strategically important to start with the training of personnel, which means to ensure the continuity of \"school - university - enterprise\" in advance. And it is necessary to start with early professional orientation of students of general educational institutions, taking into account the needs of the industry of the Kirov Region. In the secondary school of Levintsy village, we have already equipped three classrooms in the subjects of \"chemistry\", \"biology\" and \"physics\" for the organization of specialized, teaching students in grades 10-11 to study these subjects at an in-depth level,” the minister commented.\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Valentin Nikolayevich Pugach, the Rector of Vyatka State University: “With great pleasure, we organize various open events for schoolchildren so that they understand that there is a future in the region. And this is a brilliant future that is being laid today, now. At our university, we form competencies that will be in demand in decades. And for this, it is necessary not only to work with young people, but also to implement additional professional education programs for teachers in the following areas: biotechnology, biochemistry, biology, microbiology, and genetic technologies”.\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Mikhail Nekrasov, General Director of Nanolek: “In our company, 35% of our employees are specialists in biotechnology. Today, we employ more than 170 VyatSU alumni and these are young specialists with high professional training. We actively participate in the life of VyatSU students, organizing excursions to the enterprise; willingly accepting students for internships, and participating as members of the state attestation commission. It is important that the younger generation understands that they will be in demand here, in the Kirov Region, where all conditions have been created for obtaining a diploma at a prestigious university and further professional development at an innovative enterprise.”\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/40e/kkkkkkkkkkkk.jpg"},{"tag":"COMPANY NEWS","title":"Nanolek teams up with Sanofi to produce the first batch of meningococcal vaccines at the plant in the Kirov region","date":"10.03.2022","desc":"","link":"/en/news/companynews/nanolek-teams-up-with-sanofi-to-produce-the-first-batch-of-meningococcal-vaccines-at-the-plant-in-th/","inner_date":"10.03.2022","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Moscow, March 10, 2022. The first series of vaccines – 53,000 doses - has been produced at the plant of the Russian biopharmaceutical company \"Nanolek\" in the Kirov region. As part of Sanofi vaccine production localization efforts, there are plans to produce up to 3.5 million doses annually.\n</p>\n<p>\n\t An agreement on setting up a domestic production of vaccines for the prevention of meningococcal infection between Nanolek and Sanofi was signed at the Biotechmed forum in Gelendzhik in 2021. At the beginning of 2022, the first stage of technology transfer was completed and Nanolek was registered as a secondary packaging company with release control. The next stage will be the transition to aseptic bottling and other steps necessary to ensure the launch of production of finished dosage forms.\n</p>\n<p>\n\t It is planned that 2.2-3.5 million doses will be produced per year — this quantity will be enough to entirely meet the need of Russian healthcare for a vaccine for children of the first years of life for the prevention of meningococcal infection caused by pathogens of four of the most common serogroups of meningocci (A, C, W, Y).\n</p>\n<p>\n\t This step corresponds to the Global Roadmap to achieve the meningitis targets launched by the World Health Organization on September 28, 2021. The authors of the project found out that the creation of new vaccines and support for vaccine prevention worldwide will help eliminate the epidemic of bacterial meningitis by 2030. Vaccination against meningitis will protect adults and children from the infection that annually affects five million people and kills about 290 thousand lives worldwide. At the same time, a third of the recovered still have severe complications such as hearing loss, memory problems, and mental impairment.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn1\"><sup><sup>[1]</sup></sup></a>\n</p>\n<blockquote>\n\t<p>\n\t\t Frederick Jumel, General Manager of Vaccines Eurasia Unit at Sanofi:\n\t</p>\n\t<p>\n\t\t \"I am glad that we have joined efforts with our partner Nanolek to actively develop local vaccine production. I hope that this way all Russian children will be protected from meningococcal infection. The meningococcal infection has a high fatality and high disability rate after the disease. Today, we have taken an important step towards achieving our goal - to save lives and protect children from infectious diseases.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Vladimir Khristenko, president of Nanolek:\n\t</p>\n\t<p>\n\t\t \"At this challenging time, we need to focus on providing as much support to our citizens as possible, and taking care of their health is one of its most important components. We are glad that we are able to make our contribution by protecting Russian children from a deadly disease. We would like to thank our partner Sanof for joint work\".\n\t</p>\n</blockquote>\n<h3>\nAbout Menactra® vaccine</h3>\n<p>\n\t Menactra® is a polysaccharide conjugate vaccine for the prevention of meningococcal infections of four serogroups (A, C, Y, W) in children (from nine months), adolescents and adults that has been registered and used in Russia since 2014 (market authorization LP-002636 of September 22, 2014).<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn2\"><sup><sup>[2]</sup></sup></a>\n</p>\n<p>\n\t Over 7 years of using the vaccine in Russia, a lot of experience has been accumulated and local data have been collected on its high immunogenicity and favourable safety profile in children, adolescents and adults.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn3\"><sup><sup>[3]</sup></sup></a>\n\tAccording to the Headway Company report (2015–2021), Menactra® is supplied to 85 regions of the country for the immunization of children and adults; since 2014, more than 1.5 million doses have been used in various territories.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn4\"><sup><sup>[4]</sup></sup></a>\n\tThe vaccine has been used worldwide for more than 15 years<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn5\"><sup><sup>[5]</sup></sup></a>, and is registered in more than 70 countries.\n</p>\n<h3>\nAbout meningococcal infection</h3>\n<p>\n\t Children, adolescents and young adults are most often affected by meningococcal infection: these patient groups account for up to 70% of all cases. The danger of infection is that it can lead to severe generalized forms (SGFI), high mortality (10-20% of cases of SGFI) and disability after the disease (20-30% of patients who survived SGFI)<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn6\"><sup><sup>[6]</sup></sup></a>.\n</p>\n<p>\n\t The highest morbidity and mortality from SGFI is observed in children under the age of one, the incidence rates of MI in children from 0 to 4 years old exceed those in adults by about 25 times, even with timely diagnosis and the use of intensive comprehensive treatment<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn7\"><sup><sup>[7]</sup></sup></a>.\n</p>\n<p>\n\t Given the unpredictability of changes in the epidemiology of meningococcal infection in the Russian Federation, it is considered expedient to use modern conjugated meningococcal vaccines with the widest coverage of the pathogen serogroups for vaccination.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn8\"><sup><sup>[8]</sup></sup></a> Such multicomponent conjugate vaccines are highly effective and have a good safety profile, and therefore are widely used in many countries of the world<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftn9\"><sup><sup>[9]</sup></sup></a>.\n</p>\n<h3>\nBackground information:</h3>\n<p>\n\t Nanolek: a modern biopharmaceutical company, founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. The company focuses on the production of import-substituting and innovative medicines, both proprietary and those co-developed with international partners. It is one of the leaders in the production of paediatric vaccines in Russia. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases.\n</p>\n<p>\n\t Sanofi: is an innovative global company working in the field of healthcare, driven by one purpose: to chase the miracles of science to improve people’s lives. Sanofi's team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. Sanofi develops innovating treatment options and life-saving vaccine for the protection of millions of people globally, while putting sustainability and social responsibility at the center of its ambitions.\n</p>\n<p>\n\t Sanofi vaccines business unit is a world leader in the production and development of vaccines for humans. A wide variety of vaccines on the global market includes drugs for the prevention of more than fifteen viral and bacterial diseases. Every year, Sanofi produces more than one billion doses of vaccines to immunize over 500 million people worldwide. For more than 100 years of history, the mission of Sanofi's vaccines business unit has remained unchanged and is aimed at protecting life and defending human health from infectious diseases. Mono- and combined vaccines are registered in Russia to prevent dangerous childhood and adult infections:\n</p>\n<p>\n\t ● diphtheria,\n</p>\n<p>\n\t ● tetanus,\n</p>\n<p>\n\t ● pertussis,\n</p>\n<p>\n\t ● poliomyelitis,\n</p>\n<p>\n\t ● haemophilic infection type b \"Pentaxime®\", \"Adacel®\"),\n</p>\n<p>\n\t ● influenza (\"VaxigripTetra®\"),\n</p>\n<p>\n\t ● meningococcal infection (\"Menactra®\").\n</p>\n<p>\n\t Since 2017, \"Pentaxime®\" vaccine has been supplied for vaccination of children of the first years of life as part of the National preventive vaccination schedule.\n</p>\n<hr align=\"left\" size=\"1\" width=\"33%\">\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref1\"><sup><sup>[1]</sup></sup></a> Defeating meningitis by 2030: global road map\n</p>\n<p>\n <a href=\"http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pdf\">http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pdf</a> (Date of application: 31.01.2022)\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref2\"><sup><sup>[2]</sup></sup></a> Guidelines for medical use of Menactra® (market authorization LP-002636. Date of state registration: 22.09.2014.\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref3\"><sup><sup>[3]</sup></sup></a> Perminova O. A., Romanenko V. V., Rodnikova V. Yu. and others. Epidemiology and preventive vaccination. 2020; 19(2): 70-78\n</p>\n<p>\n\t Izvekova I. Ya., Namazova-Baranova L. S., Gogolev A., V. and others Epidemiology and preventive vaccination. 2018;17(6):19-34\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref4\"><sup><sup>[4]</sup></sup></a> Headway Company report (2015-2021)<a href=\"https://www.hwcompany.ru/presscenter\">https://www.hwcompany.ru/presscenter</a> (as of February 1, 2022).\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref5\"><sup><sup>[5]</sup></sup></a> Food and drug administration (FDA). Vaccines Licensed for Use in the United States\n</p>\n<p>\n <a href=\"https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states\">https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states</a> (as of January 1, 2022)\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref6\"><sup><sup>[6]</sup></sup></a>\n\tSadarangani M, Pollard AJ. Clin Microbiol Infect 2016; 11:S103-S112\n</p>\n<p>\n\t Pace D, Pollard AJ. Vaccine 2012; 30(Suppl. 2):B3-B9\n</p>\n<p>\n\t Sadarangani M, Pollard AJ. Neisseria meningitidis (meningococcus). In: Kliegman RM, editor. Nelson textbook of pediatrics. 20th ed. Philadelphia: Elsevier; 2016. p. 1356-1365\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref7\"><sup><sup>[7]</sup></sup></a> On the state of sanitary and epidemiological well-being of the population in the Russian Federation in 2020: State report. М.: Federal Service for Supervision of Consumer Rights Protection and Human Welfare, 2021. 256 p.\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref8\"><sup><sup>[8]</sup></sup></a> SanPiN 3.3686-21 \"Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases\"\n</p>\n <br>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA%20%D0%B8%20%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%B2%D1%8B%D0%BF%D1%83%D1%81%D1%82%D0%B8%D0%BB%D0%B8%20%D0%BF%D0%B5%D1%80%D0%B2%D1%83%D1%8E%20%D0%BF%D0%B0%D1%80%D1%82%D0%B8%D1%8E%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_eng.docx#_ftnref9\"><sup><sup>[9]</sup></sup></a> Vaccines, 7th ed. / [edited by] Stanley A. Plotkin, Walter A. Orenstein, Paul A. Offit. Philadelphia, PA: Elsevier, 2018\n</p>\n <br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/270/uuuuuuuuuu.jpg"},{"tag":"COMPANY NEWS","title":"Official message of Nanolek to colleagues and partners","date":"02.03.2022","desc":"","link":"/en/news/companynews/official-message-of-nanolek-to-colleagues-and-partners/","inner_date":"02.03.2022","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On behalf of Nanolek we would like to address all our friends, colleagues and partners.\n</p>\n<p>\n\t Our company produces pharmaceutical products for the prevention and treatment of socially significant diseases. Our mission is to protect the lives and health of people, making the world's best technologies available to everyone. To everyone who needs them, regardless of their beliefs.\n</p>\n<p>\n\t Two years ago, we faced a challenge as the COVID-19 pandemic hit the whole world. And we have proven to our partners and patients, and to ourselves, that the company's values are not just mere words alone, that they are confirmed by real deeds and a friendly team.\n</p>\n<p>\n</p>\n<p>\n\t Today, we are witnessing a challenging time once again. We are seeing now a lot of noise, false reports, and even experts fail to verify the facts, however time will put everything in its place.\n</p>\n<p>\n</p>\n<p>\n\t We want you to know that we are not going to halt production, interrupt deliveries or stop the development process as we have obligations towards our partners and patients who are in vital need of medicines that we produce. That is why we need to continue doing our job. Our experts simply have no right to wallow in sadness and panic. Nowadays, everyone of us needs to organize their thoughts in order to focus on work and at the same time spend more time with their families and loved ones.\n</p>\n<p>\n\t Currently, despite a dramatic decline in the ruble exchange rate, our company maintains a stable position. Top managers of Nanolek keep track of events, are in close negotiations with suppliers, partners and customers, and seek to take measures to maintain the solvency of the company.\n</p>\n<p>\n\t People need our services. We continue to work.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/1ec/Obrashchenie-sayt.jpg"},{"tag":"COMPANY NEWS","title":"The Kirov region launches the production of CoviVac vaccines. By year-end, 250 thousand doses are expected to be produced","date":"17.12.2021","desc":"","link":"/en/news/companynews/the-kirov-region-launches-the-production-of-covivac-vaccines-by-year-end-250-thousand-doses-are-expe/","inner_date":"17.12.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t December 17, 2021, Kirov. Nanolek, a biopharmaceutical company, has begun production of the CoviVac vaccine, which was developed by specialists at the Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of the Russian Academy of Sciences. This is the first collaborative project implemented between two future Biopolis special economic zone residents.\n</p>\n<p>\n</p>\n<p>\n\t On December 17, the Nanolek plant in the Kirov region officially began production of CoviVac, a coronavirus vaccine developed by the Chumakov Center. The event was attended by Igor Vasiliev, Governor of the Kirov region, Aidar Ishmukhametov, CEO of the Chumakov Center, and Vladimir Khristenko, President of Nanolek. Previously, CoviVac was manufactured at one location only: the Chumakov Center in Moscow. Since it was modernized in the fall of 2021, the Center has been able to increase production volumes by 2-2.5 times and achieve a monthly capacity utilization of one million doses.\n</p>\n<p>\n</p>\n<p>\n\t Nanolek and the Chumakov Center began their collaboration back in 2019 with the establishment of a joint venture. Nanolek is the only manufacturer in Russia to produce an inactivated polio vaccine in a ready-to-use formulation, while the Chumakov Center developed oral polio vaccines and pioneered the development of one of the world's first inactivated polio vaccines using Sabin strains. The decision to team up made sense. In 2021, the partnership continued with the project to establish a second CoviVac production site in the Russian Federation: a line for the production of inactivated vaccine was already in place at the plant in the Kirov region. Additional equipment and a technology transfer were required for the production of CoviVac vaccines.\n</p>\n<p>\n</p>\n<p>\n\t Nanolek became a project partner in the spring of 2021. The Nanolek plant began transferring technology in the summer and although a production transfer of this size takes normally at least a year, the company completed it in just four months.\n</p>\n<p>\n</p>\n<p>\n\t In 2021, Nanolek invested 40 million rubles in the CoviVac project. According to the company, this project is a social venture. Indeed, the specified prices and labor intensity of production do not allow recouping of funds invested. A total of 250 thousand doses will be produced by the end of 2021 and delivered to the Chumakov Center, which is both the vaccine's developer and its customer. Now that the production of CoviVac has started, Nanolek is prepared to produce 10 million doses per year. Thus, if there is a need for additional bottling capacity in Russia or if export production of this vaccine becomes feasible, the company can promptly render necessary assistance.\n</p>\n<p>\n</p>\n<p>\n\t The launch of CoviVac vaccine production at the Kirov region plant is the first collaborative effort between the Chumakov Center and Nanolek, two future residents of the Biopolis special economic development zone. In November 2021, Governor of the Kirov Region Igor Vasiliev announced details of the Biopolis development roadmap.\n</p>\n<p>\n</p>\n<p>\n\t Biopolis is a large-scale federal project that is part of Russia's efforts to build a sanitary shield. It is anticipated that within ten years schools with a biotechnological focus and a scientific and educational center will be built in the village of Levintsy (Kirov region), the nearest settlement to the Nanolek plant. It is also planned to \"set up\" in Levintsy 10+ resident companies with a focus on biotechnology and ESG. For example, the construction of a branch of the Chumakov Center specializing in the development of vaccines is scheduled to be launched in 2024.\n</p>\n<p>\n</p>\n<p>\n\t An official agreement was signed on December 17, 2021 between Nanolek, Biopolis' anchor resident, and Kirov region Governor Igor Vasiliev. During the signing ceremony, Nanolek President Vladimir Khristenko stated that the company had already begun developing the project's marketing concept in collaboration with a team of Marketing and Brand Management students fr om the British Higher School of Art & Design (Moscow).\n</p>\n<p>\n</p>\n<p>\n <b>Quotes:</b>\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t Igor Vasiliev, Governor of the Kirov region:\n\t</p>\n\t<p>\n\t\t \"This is a landmark event for the region and our residents. The production of vaccines everybody is in need of and the maintenance of a healthy population are essential for the well-being, stability, and future development of the region. This is not the first time the Chumakov Center and the Kirov region have worked closely together: last year, we collaborated on a successful study of the first coronavirus vaccine. This progression is also linked to \"disruptive projects\" being unrolled in the region. One of these projects is the creation of a special economic zone, wh ere Nanolek will be the anchor investor.\n\t</p>\n\t<p>\n\t\t Following in the footsteps of Tatarstan Innopolis, it is planned to build a Biopolis city in Levintsy complete with all social and educational infrastructure, including schools and kindergartens, polyclinics, employee housing, and possibly a university campus. Funds will be raised from private investors as well as federal and regional budgets to bring the project to fruition. The application to establish a special economic zone is scheduled for submission early next year.\"\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t Vladimir Khristenko, President of Nanolek Biopharmaceutical Company:\n\t</p>\n\t<p>\n\t\t \"It is easy to see from the numbers that Nanolek's production of CoviVac is primarily a social project. We put our money in it without having an approved return on investment plan in place. We did so because pharmaceutical companies must respond quickly and do their best to preserve people's lives and health during the pandemic. Joint projects with the Chumakov Center, as a future resident of the Biopolis special economic development zone, are particularly important to our company. Nanolek will become the backbone company of Biopolis, a city of scientists based on the village of Levintsy, which is the closest settlement to our plant in the Kirov region. Strong, like-minded partners are especially appealing to us. Indeed, you can’t create a sanitary shield for the country and build an entirely new city alone, without support.\"\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t Aidar Ishmukhametov, General Director of the Chumakov Center:\n\t</p>\n\t<p>\n\t\t \"Launch of production of a safe and effective CoviVac vaccines in the Kirov region with our partners is truly important to us. We produced 6 million doses of CoviVac vaccines in 2021, and expect to release and distribute 20 million doses across the domestic market in 2022. All these doses will be in high demand in Russia.\"\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t Andrey Purtov, Head of the Marketing and Brand Management course of the British Higher School of Art & Design:\n\t</p>\n\t<p>\n\t\t \"The development of a marketing strategy for the world-class Biopolis special economic zone is the name of the project that one of the teams of the Marketing and Brand Management course is currently working on. Regional projects have a diverse range of target audiences: local residents, tourists, businesses, investors, the academic community, and government officials – each of whom requires a unique value proposition and a distinct territorial brand. This is the reason why they are among the most challenging projects. We already have experience working with a variety of Russian territories through the Marketing and Brand Management course — Kazan, Krasnodar, Murmansk region, Zvenigorod, Yakutia, Kamchatka, Penza, and Altai. However, we will work for the first time on a special economic zone project that is destined to become a small city. I would like to point out that this project is non-for-profit for Nanolek because it was chosen and integrated into the educational process of the British Higher School of Art & Design's Marketing and Brand Management course.\"\n\t</p>\n</blockquote>\n<p>\n <b>Reference information:</b>\n</p>\n<p>\n <b>Nanolek:</b> a modern biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. The company focuses on the production of import-substituting and innovative medicines, both proprietary and those co-developed with international partners. One of the market leaders in the production of pediatric vaccines in Russia. In addition to vaccines, the company's product portfolio includes medicines for the treatment of HIV, cancer, and orphan diseases.\n</p>\n<p>\n</p>\n<p>\n <b>Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of the Russian Academy of Sciences: </b>established on the premises of the Institute of Polio and Viral Encephalitis of the Academy of Medical Sciences of the USSR. The founder and the first director of the Institute was Academician of the USSR Academy of Medical Sciences Mikhail Chumakov. The Chumakov Center is one of the world's leading scientific institutions in medical virology, including in the study of polio and other enterovirus infections, tick-borne encephalitis, coronavirus and viral hepatitises. The Center has its own biotechnological vaccine manufacturing facility for the immunization schedule.\n</p>\n<p>\n\t British Higher School of Design: a non-governmental educational private institution offering higher education in art, design, business and marketing, established in 2003. The British Higher School of Art & Design is part of Universal University, an educational institution that shapes the prospects of creative industries, fosters a new expert community and gives people a wide range of opportunities for both personal and professional growth throughout their lives.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e41/4_vot_etot_fayl.jpg"},{"tag":"COMPANY NEWS","title":"Safer and More Well-Tolerated: Comparison of the First Russian HPV Vaccine to Its American Peer","date":"22.11.2021","desc":"","link":"/en/news/companynews/safer-and-more-well-tolerated-comparison-of-the-first-russian-hpv-vaccine-to-its-american-peer-/","inner_date":"22.11.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t November 22, 2021. The Russian biopharmaceutical company Nanolek announces the results of the 1st phase of a clinical trial aimed at comparing a new HPV vaccine developed in-house with a vaccine of the same type produced in the USA. The domestic drug showed a more favourable safety profile and better tolerability.\n</p>\n<p>\n\t Human papillomavirus (HPV) causes cancers and precancerous conditions of the cervix, vagina, external female genitals, penis and anus, and some head and neck cancers in adults. According to findings <a href=\"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02178-4/fulltext\">published</a> in 2021 in the Lancet scientific journal, HPV vaccination lowers by 90% the risk of cervical cancer, a disease that kills more than 300,000 people every year. This vaccine does not relate to a particular age, but WHO recommends vaccinating girls from 9 to 13 years old and people aged 27-45, in particular those living with HIV and smokers in the first place. The vaccine has been included in the National vaccination schedules in 91 countries worldwide. Now it is included in some regional vaccination schedules in Russia, and is expected to be added to the National schedule in 2024. Up to date, only foreign vaccines have been put into the stream of commerce.\n</p>\n<p>\n\t The first phase of a clinical trial of a new domestic HPV vaccine was carried out from July to November 2021 at the research center of Kirov State Medical University. Two quadrivalent recombinant vaccines against human papillomavirus (HPV) were compared — a domestic vaccine developed by Nanolek in partnership with Kombiotech, and the American one, manufactured by Merck Sharp & Dohme (USA). According to the findings, the Russian medication showed a high tolerability and safety profile. The risk of adverse events was 7% lower than that of the reference drug, while all the changes in the subjects' well-being were mild - these were chiefly reactions at the place of injection, e. g. redness, itching, and/or pain on palpation. The Russian vaccine also showed good immunogenicity: most volunteers developed antibodies to all four of the most common oncogenic strains after a single injection.\n</p>\n<p>\n\t “The first phase of the clinical trial confirms the high quality of the HPV vaccine that our company is developing in partnership with Kombiotech. For Nanolek, the development and production of vaccines is a key priority. And we are proud that another socially important medicine will enhance our portfolio to ensure the highest possible protection of Russian women from the common type of cancer,\" says Vladimir Khristenko, president of Nanolek, adding that Nanolek plans to invest about 2 billion roubles in the development and entire production cycle of the Russian vaccine.\n</p>\n<p>\n\t The next phase of trials is a randomized comparative clinical trial involving more than a thousand volunteers. And only then Nanolek will proceed to efforts towards setting up a production facility.\n</p>\n<p>\n\t \"We plan to launch it on the market by 2024. In terms of production volumes, we are going to completely cover the need for this vaccine in Russia and also produce it for export,\" said Maksim Stetsyuk, Head of the vaccine division and First Deputy General Director at Nanolek. \"We hope that the HPV vaccine will be included in the National vaccination schedule later this year, as the government plans. In this case, all Russian girls aged 9 to 13 will be able to receive a vaccine shot free of charge.\"\n</p>\n<p>\n\t Clinical Trials of the First Domestic HPV Vaccine\n</p>\n<p>\n\t Tolerability and Safety. To assess the safety profile in control groups, the number of adverse events (AE) was measured — negative changes in the health condition of the subjects. The risk of adverse events in those who tested the Russian vaccine was 7% lower: AEs were observed in 13% of volunteers, whereas in the group of subjects exposed to reference drug - in 20% of volunteers.\n</p>\n<p>\n\t In group 1 (Russian vaccine), 60% of general disorders and reactions at the place of injection were communicated (pain at the place of injection, pain on palpation, and itching at the vaccination place), 20% of AEs were observed in the blood and lymphatic system (regional lymphadenopathy) and 20% of AEs accrued to the reproductive system (menstrual irregularities). In terms of intensity, 100% of AEs were classified as mild. None of the volunteers was in need of drug therapy to eliminate the AEs. In all cases of AEs (100%), the outcome was \"recovery/comeback without consequences.\"\n</p>\n<p>\n\t Clinically significant deviations of laboratory parameters from the norm were not registered in any of the volunteers.\n</p>\n<p>\n\t Immunogenicity\n</p>\n<p>\n\t For the first trial phase, immunogenicity assessment was not the primary task and was supplementary. All volunteers who received the Russian vaccine became seropositive for all four types of HPV one month after a single vaccination. As many as 100% of the volunteers who received the reference drug became anti-HPV 6, anti-HPV 11, anti-HPV 16 seropositive, and 96.7% of the volunteers became anti-HPV 18 seropositive.\n</p>\n<p>\n\t At the same time, rising antibody titers in group 1 (Russian vaccine) was the case for subtype 6 in 89.7% of volunteers, for subtype 11 - in 100% of volunteers, for subtype 16 - in 82.8%, and for subtype 18 - in 86.2 % of volunteers. In group 2 (foreign drug), rising antibody titers were observed for subtype 6 in 90% of volunteers, for subtype 11 - in 93.3% of volunteers, for subtype 16 - in 100%, and for subtype 18 - in 80% of volunteers.\n</p>\n<p>\n\t The average geometric titer of antibodies on the 28th day after vaccination in both groups was 4–30 times higher, depending on the HPV type, relative to the baseline level.\n</p>\n<p>\n\t Thus, in serum samples taken on the 28th day after a single vaccination with both the Russian vaccine and the reference drug, showed an increase in specific influenza antibodies in the majority of volunteers against all four most common oncogenic strains. The rising antibodies against human papillomaviruses of all types after vaccination with the tested vaccine and the reference drug occurred similarly, which is an indication of the comparability of the intensity of the immune response in the compared drugs.\n</p>\n<p>\n\t About Nanolek: a modern biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov, specializing in the production of import-substituting and innovative drugs, both developed in-house and created with international partners. Nanolek is one of the leaders in the production of pediatric vaccines in the Russian Federation. In addition to vaccines, the Nanolek’s portfolio includes drugs to treat HIV, cancer, and orphan diseases.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/866/Rituksimab.jpg"},{"tag":"COMPANY NEWS","title":"BeiGene and Nanolek Announce Approval in Russia for BRUKINSA® (Zanubrutinib) for Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma","date":"21.10.2021","desc":"","link":"/en/news/companynews/beigene-and-nanolek-announce-approval-in-russia-for-brukinsa-zanubrutinib-for-treatment-of-patients-/","inner_date":"21.10.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n <i>This marks the first regulatory approval for BRUKINSA in Russia </i>\n</p>\n <i> </i>\n<p>\n <i>\n\tBRUKINSA is now approved for the treatment of MCL in ten countries, following the U.S., China, Canada, Australia, and others </i>\n</p>\n <i> </i>\n<p>\n <i>\n\tBeiGene is committed to rapidly advancing the global registration of BRUKINSA on its own and alongside strategic collaborators </i>\n</p>\n <i> </i>\n<p>\n <i>\n\tUnder an exclusive distribution agreement, Nanolek will commercialize BRUKINSA in Russia</i>\n</p>\n<p>\n <b>CAMBRIDGE, Mass., BEIJING and MOSCOW -- October 20, 2021 </b>-- BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Nanolek, a biopharmaceutical company specializing in the production of import-substituting and innovative drugs in Russia, today announced that BRUKINSA<sup>® </sup>(zanubrutinib) has received approval from the Russia Ministry of Health for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene and Nanolek entered into an exclusive distribution agreement for Nanolek to commercialize BRUKINSA in the Russian Federation.\n</p>\n<p>\n\t “The registration of BRUKINSA (zanubrutinib), a next-generation BTK inhibitor that demonstrated improved clinical benefit while reducing the frequency of certain off-target side effects in MCL, will give physicians and patients another treatment option. BRUKINSA has the potential to give those impacted by MCL in Russia an improved prognosis and a more tolerable therapeutic option,” commented Irina Vladimirovna Poddubnaya, Professor, Academician of Russian Academy of Sciences (RAS), and Head of Oncology Department at the Russian Medical Academy of Postgraduate Education. \n</p>\n<p>\n\t “This approval reinforces BRUKINSA’s potential as a best-in-class BTK inhibitor for the treatment of hematological malignancies, and we are pleased to make it available to MCL patients in Russia,” said Jane Huang, M.D., Chief Medical Officer, Hematology, BeiGene. “We are working to improve outcomes for patients living with cancer, wherever they live, and this year have secured 12 regulatory approvals for BRUKINSA in the United States, Canada, Latin America, and the APAC and EMEA regions.”\n</p>\n<p>\n\t “We look forward to collaborating with Nanolek to bring a much needed new treatment option to MCL patients in Russia,” said Vitaly Sokolinsky, Senior Director, New Market Development, Russia, at BeiGene. “Today’s approval in MCL highlights our continued expansion into Russia, greater Europe and beyond as we bring our expertise to new markets around the world.”\n</p>\n<p>\n\t “We’re proud of this significant achievement for patients and look forward to contributing to BRUKINSA’s growing global footprint through our strong collaboration with BeiGene,” added Vladimir Khristenko, President of Nanolek. “Together, we are committed to delivering innovative therapies for the benefit of people impacted by cancer in Russia.”\n</p>\n<p>\n\t Marketing approval for BRUKINSA for the treatment of MCL in Russia is based on results from two single-arm clinical trials. Across both trials, as assessed by independent review committee (IRC) per 2014 Lugano Classification, BRUKINSA achieved an overall response rate (ORR) of 83.7%, defined as the combined rate of complete responses (CRs) and partial responses (PRs).\n</p>\n<p>\n\t Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, serious adverse reactions occurred in 36 patients (31%), with the most frequent being pneumonia (11%) and bleeding (5%). Eight patients (7%) discontinued treatment due to adverse reactions in the trials, with the most frequent being pneumonia (3.4%), and one patient (0.8%) experienced an adverse reaction that led to dose reduction.\n</p>\n<p>\n\t The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.\n</p>\n<h3>\nAbout Mantle Cell Lymphoma (MCL) </h3>\n<p>\n\t MCL is rare form of non-Hodgkin lymphoma (NHL), representing about 5% of all NHL cases.<sup>1</sup> It develops in the outer edge of a lymph node called the mantle zone.<sup>1</sup> Mantle cell lymphoma occurs more often in men than in women.<sup>1</sup> It is usually diagnosed in people in their early 60s.<sup>1</sup> MCL has a poor prognosis, with a median survival of three to four years, and is often diagnosed at a later stage of disease.<sup>2</sup> In Russia, there are more than 1,000 new cases of MCL diagnosed each year.<sup>3</sup>\n</p>\n<h3>\nAbout BRUKINSA </h3>\n<p>\n\t BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.\n</p>\n<p>\n <b>BRUKINSA is approved in the following indications and regions:</b>\n</p>\n<ul type=\"disc\">\n\t<li>For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;</li>\n\t<li>For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;</li>\n\t<li>For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;</li>\n\t<li>For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);</li>\n\t<li>For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);</li>\n\t<li>For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**; </li>\n\t<li>For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021);</li>\n\t<li>For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021);</li>\n\t<li>For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021);</li>\n\t<li>For the treatment of adult patients with WM (United States, August 2021); </li>\n\t<li>For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*;</li>\n\t<li>For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021); </li>\n\t<li>For the treatment of MCL in patients who have received at least one prior therapy (Israel, October 2021);</li>\n\t<li>For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021); </li>\n\t<li>For the treatment of adult patients with MCL who have received at least one prior therapy (Australia, October 2021); and</li>\n\t<li>For the treatment of adult patients with MCL who have received at least one previous therapy (Russia, October 2021). </li>\n</ul>\n<p>\n\t To date, more than 30 marketing authorization applications in multiple indications have been submitted in the United States, China, the European Union, and more than 20 other countries or regions.\n</p>\n<p>\n\t * This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.\n</p>\n<p>\n\t ** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.\n</p>\n<p>\n\t IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)\n</p>\n<p>\n\t Warnings and Precautions\n</p>\n<p>\n\t Hemorrhage\n</p>\n<p>\n\t Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.4% of patients treated with BRUKINSA monotherapy. Hemorrhage events of any grade occurred in 35% of patients treated with BRUKINSA monotherapy.\n</p>\n<p>\n\t Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.\n</p>\n<p>\n\t Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.\n</p>\n<p>\n\t Infections\n</p>\n<p>\n\t Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 27% of patients, most commonly pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.\n</p>\n<p>\n\t Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.\n</p>\n<p>\n\t Cytopenias\n</p>\n<p>\n\t Grade 3 or 4 cytopenias, including neutropenia (26%), thrombocytopenia (11%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia occurred in 3.6% of patients.\n</p>\n<p>\n\t Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.\n</p>\n<p>\n\t Second Primary Malignancies\n</p>\n<p>\n\t Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 8% of patients. Other second primary malignancies included malignant solid tumors (4.0%), melanoma (1.7%) and hematologic malignancies (1.2%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.\n</p>\n<p>\n\t Cardiac Arrhythmias\n</p>\n<p>\n\t Atrial fibrillation and atrial flutter were reported in 3.2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 1.1% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.\n</p>\n<p>\n\t Embryo-Fetal Toxicity\n</p>\n<p>\n\t Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose.\n</p>\n<p>\n\t If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.\n</p>\n<p>\n\t Adverse reactions\n</p>\n<p>\n\t The most common adverse reactions, including laboratory abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847) included decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%), hemorrhage (35%), decreased lymphocyte count (31%), rash (31%) and musculoskeletal pain (30%).\n</p>\n<p>\n\t Drug Interactions\n</p>\n<p>\n\t CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.\n</p>\n<p>\n\t CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers.\n</p>\n<p>\n\t Specific Populations\n</p>\n<p>\n\t Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.\n</p>\n<p>\n\t Please see full U.S. Prescribing Information at <a href=\"http://www.beigene.com/PDF/BRUKINSAUSPI.pdf?loc=US\">www.beigene.com/PDF/BRUKINSAUSPI.pdf</a> and Patient Information at <a href=\"https://www.globenewswire.com/Tracker?data=DG6XNmXMYkuTYIrVUjn7k1oxF7wH0nAaKusY1AomV8hSyp0AF8c3w1BpcX3cEbxLvBX4HfKgifmrPsQcxSvBRu_fP8UpQqrrRlGvwK218_qEz86gjlTmdNy9jbQHTY9zP6s-VTKdEJH83DWPaxflFw==&loc=US\" target=\"_blank\">www.beigene.com/PDF/BRUKINSAUSPPI.pdf</a>.\n</p>\n<h3>\nBeiGene Oncology </h3>\n<p>\n\t BeiGene is committed to advancing hematology, immuno-oncology and targeted therapies in order to bring impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy subjects. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries or regions. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, Australia and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China. BeiGene has a high quality, innovative science and medicine organization and is a leader in China with a large oncology focused commercial team.\n</p>\n<p>\n\t BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.\n</p>\n<h3>About BeiGene</h3>\n<p>\n\t BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,000 colleagues across five continents. To learn more about BeiGene, please visit <a href=\"http://www.beigene.com\">www.beigene.com</a> and follow us on Twitter at <a href=\"https://twitter.com/BeiGeneGlobal\">@BeiGeneGlobal</a>.\n</p>\n<h3>About Nanolek</h3>\n<p>\n\t Nanolek is a Russian biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov, specializing in the production of import-substituting and innovative drugs, both developed in-house and created with international partners. It is one of the leaders in the production of pediatric vaccines in Russia. A total of 20 medicines are now in the Nanolek’s portfolio, with 35 more at various stages of preparation for release and will hit the market within the next five years. The company's plant in the Kirov region that opened in 2014 was built with an eye on the best international practices and technologies. The production facility is GMP-certified and besides regularly passes quality audits performed by major international pharmaceutical corporations: Nanolek plant produces drugs in cooperation with such companies as Sanofi, Janssen, Merck.\n</p>\n<p>\n\t Nanolek supports scientific educational initiatives through active collaboration with RSOH (Russian Society of Oncohematologists).The company contributes to the development of a further educational program for hematologists on future clinical indications: CLL, Waldenström’s macroglobulinemia and marginal zone cell lymphoma. <a href=\"http://www.nanolek.ru/\">www.nanolek.ru</a>.\n</p>\n<p>\n <b>Forward-Looking Statements</b>\n</p>\n<p>\n\t This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding plans for development and commercialization of BRUKINSA in Russia and other markets, the potential commercial opportunity for BRUKINSA, plans for making BRUKINSA accessible to patients in Russia, the potential for BRUKINSA to be a best-in-class BTK inhibitor and to provide improved clinical benefits to patients, and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.\n</p>\n<p>\n</p>\n<p>\n</p>\n<p>\n</p>\n<p>\n</p>\n<p>\n <b>BeiGene Contacts</b>\n</p>\n<p>\n\t Investor Contact\n</p>\n<p>\n\t Gabrielle Zhou\n</p>\n<p>\n\t +86 10-5895-8058\n</p>\n<p>\n <a href=\"mailto:ir@beigene.com\">ir@beigene.com</a>\n</p>\n<p>\n\t Media Contact\n</p>\n<p>\n\t Emily Collins\n</p>\n<p>\n\t +1 201-201-4570\n</p>\n<p>\n <a href=\"mailto:media@beigene.com\">media@beigene.com</a>\n</p>\n <br>\n <br>\n<p>\n</p>\n<p>\n <b>Nanolek Contact</b>\n</p>\n<p>\n\t Press Office\n</p>\n<p>\n\t Anna Karabash\n</p>\n<p>\n\t +7 929 602-61-04\n</p>\n<p>\n <a href=\"mailto:prnanolek@gmail.com\">prnanolek@gmail.com</a>\n</p>\n<p>\n <b>References:</b>\n</p>\n<p>\n\t 1 Lymphoma Research Foundation. Understanding Mantle Cell Lymphoma. Available at <a href=\"https://lymphoma.org/wp-content/uploads/2018/10/MantleCellLymphomaFact-Sheet.pdf\">https://lymphoma.org/wp-content/uploads/2018/10/MantleCellLymphomaFact-Sheet.pdf</a> Accessed October 2021.\n</p>\n<p>\n\t 2 Philip J. Bierman, James O. Armitage, in Goldman's Cecil Medicine (Twenty Fourth Edition), 2012.\n</p>\n 3 <a href=\"https://glavonco.ru/cancer_register/%D0%9F%D0%BE%D0%BC%D0%BE%D1%89%D1%8C%202019.pdf\">https://glavonco.ru/cancer_register/%D0%9F%D0%BE%D0%BC%D0%BE%D1%89%D1%8C%202019.pdf</a>.\nAccessed October 2021. \t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/092/x-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk Takes Part in the Forbes Conference \"Sustainable Healthcare, Investments, Technologies, and Management\"","date":"08.10.2021","desc":"","link":"/en/news/companynews/maxim-stetsyuk-takes-part-in-the-forbes-conference-sustainable-healthcare-investments-technologies-a/","inner_date":"08.10.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t First Deputy General Director, Director of the Vaccines Division at Nanolek delivered a speech at the session \"Pharmaceuticals of the New Time: Market Trends and Investment Goals.\" The session was moderated by Elena Kalinovskaya, Head of Analytics at Pharmaceutical Bulletin and Medical Bulletin. Anton Lavrentiev, CEO, Primer Capital; Pavel Morozov, Managing Partner of Skolkovo Ventures, and Konstantin Sharlovsky, Head of Pharmaceuticals and Healthcare Practice at Pepeliaev Group were involved in the discussion as well.\n</p>\n<p>\n\t The participants discussed new opportunities and challenges the pandemic has brought to the industry, trends that are now crucial for the pharmaceutical industry, the government's role in the development of the sector, and problems investors are facing today.\n</p>\n<p>\n</p>\n<p>\n\t Maxim Stetsyuk explained why the calls to \"make your products and full-cycle production\" sound beautiful and straightforward, but these efforts are not always practicable.\n</p>\n<blockquote>\n\t<p>\n\t\t \"We need to develop pharmaceuticals and all related industries, to produce equipment for factories. We are moving towards biotech products, and this is a complex production. The pandemic revealed that we are ready to set up production, but there are difficulties with the equipment. Getting a molecule in a test tube is just a part of the trouble; it is vital to scale up production, transfer it to large reactors and build necessary infrastructure,\" said the expert. \n\t</p>\n</blockquote>\n<p>\n\t This being said, the experience of Nanolek proves that it is realistic to produce products domestically and even export them. If you are planning to export your products, you have to comply with foreign regulations, with new requirements emerging on a continuous basis. The main proof is quality control, which takes place in several stages and involves 250 of the 700 factory employees. Besides, Nanolek cooperates with multinational companies and undergoes 12 audits a year. Maxim also noted that Russian companies dealing with bioproducts often face a shortage of personnel. We have only a few scientists in the relevant industries in Russia, and they need to be educated and raised fr om school days. \n</p>\n<blockquote>\n\t<p>\n\t\t \"The period of the pandemic has shown that for the next ten years, we need to partner with institutions, scientific institutions, public and private partnerships, and businesses to work in a coherent team. This is a combination, wh ere each participant is an expert in his particular field, this is how they work in the West, because the Western countries have long abandoned the model when all processes are performed in-house,\" commented M. Stetsyuk. \n\t</p>\n</blockquote>\n<p>\n\t The session participants paid particular attention to the problems of investments in projects of the pharmaceutical industry. Pavel Morozov, the managing partner of Skolkovo Ventures, posed himself a question: why do the \"crossover investors\" not invest in medicine, which is always at the top of priorities, like food and education? The reason is that the market in Russia is well-regulated, in contrast to the United States, where money is of primary importance to the system, not government regulation. The developers of new medical devices in Skolkovo may e.g. not receive investor capital only because investors do not understand at what prices medical devices will be sold and in what quantities will they be purchased by the governmental authorities. \"We need to reconsider the basic approach, we need transparent regulation, and the pricing should be clear,\" Pavel summed up.\n</p>\n<p>\n\t Speaking about investments, Maxim Stetsyuk confirmed that it is a tricky task to attract venture capital into medicine. In his opinion, this is also due to long terms of drug development: at least seven years, while investors want to see results in two or three years. \n</p>\n<blockquote>\n\t<p>\n\t\t \"There are medicines with a long-term forecasting and planning cycle,\" explained M. Stetsyuk. Their production takes 22 months, and there is a time when people have to work 48 hours a day and then there is a period when you need to dismiss all workers for a quarter. It may be the case when one plant should be built for one vaccine, and the need for vaccines is 3 million doses per year, and investors do not express any interest in that. In such circumstances, you should either cooperate with the government or try to tap into foreign markets. This is an approach used by large companies that have access to markets of 100–150 countries.\" \n\t</p>\n</blockquote>\n<p>\n\t In this context, a member of the Nanolek Management Board is confident that investors in the pharmaceutical industry have a wide choice: no matter what they invest in, whether it is development, infrastructure, or IT solutions, the main thing that matters is an expertise in the chosen direction.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/5db/x-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk Takes Part in the Import Substitution Session of the Biotechmed Forum","date":"06.10.2021","desc":"","link":"/en/news/companynews/maxim-stetsyuk-takes-part-in-the-import-substitution-session-of-the-biotechmed-forum/","inner_date":"06.10.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On the second day of the Biotechmed Forum, the First Deputy General Director of Nanolek Maksim Stetsyuk took part in the session called \"Import Substitution. What are we substituting?\" The discussion was moderated by Vasily Osmakov, the First Deputy Minister of Industry and Trade of the Russian Federation.\n</p>\n<p>\n\t The participants discussed various factors in development of domestic production - from production of substances, raw materials, and materials for their production to laboratory and processing equipment development.\n</p>\n<p>\n\t If we wish to develop innovative drugs in Russia, we should encourage the localization of pharmaceutical plants in the country primarily focused on producing the most commonly used medicines in Russia. Although pharmaceutical companies were rather fast in reacting to the pandemic challenges, in some cases there were serious problems due to the disruption of supply chains and delivery of substances and consumables from abroad.\n</p>\n<p>\n\t According to Dmitry Galkin, Head of the Department for Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia, it is planned that domestic drugs will in 10 years account for at least 65% of the total sales of VED (vital and essential drugs) in terms of a complete cycle. Availability of such drugs used for the treatment of socially significant and dangerous diseases will be at least 70%.\n</p>\n<blockquote>\n\t<p>\n\t\t Maxim Stetsyuk expressed his point of view: \"The Ministry of Health is facing a challenge to implement the strategy of import substitution, and to ensure the immunobiological security of the country by making some medicines available. It should be kept in mind that it will take years, if not decades to complete these measures. And we must understand today what will be in demand in 5-10 years from now so that we all - the government, manufacturers, and science - move in the same direction towards a specific goal.\"\n\t</p>\n</blockquote>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/659/x-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Sanofi Pasteur and Nanolek Sign an Agreement on Domestic Production of Meningitis Vaccines to Produce up to 3.5 Million Doses Annually in Russia Starting From 2022","date":"04.10.2021","desc":"","link":"/en/news/companynews/sanofi-pasteur-and-nanolek-sign-an-agreement-on-domestic-production-of-meningitis-vaccines-to-produc/","inner_date":"04.10.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t October 4, 2021. The agreement on domestic production of Menactra<sup>®</sup>\n\tvaccines to prevent meningococcal infection was signed at the Biotechmed forum in the city of Gelendzhik. The ceremony was attended by Denis Manturov, the Minister of Industry and Trade of the Russian Federation, and Mikhail Murashko, the Minister of Health of the Russian Federation.\n</p>\n<p>\n\t The next stage is the transfer of quality control procedures and packaging processes for the Menactra<sup>®</sup> vaccine and the signing of an addendum on the conditions for aseptic filling and other steps to localize the production of vaccines, including the production of finished dosage forms.\n</p>\n<p>\n\t Menactra<sup>®</sup> will be manufactured at the innovative Nanolek plant in the Kirov Region. According to the production plan, the first batches will be released in 2022. The plant is expected to produce 2.2-3.5 million doses per year. This volume would be enough to completely satisfy the needs of Russian healthcare for a vaccine in the prevention of meningococcal infection caused by pathogens of the four most common serogroups at a time: A, C, W, Y.\n</p>\n<p>\n\t These efforts are in line with the <a href=\"https://www.meningitis.org/maw2021\">Global Roadmap</a> to achieve the meningitis targets launched by the World Health Organization in September 28, 2021. The project authors figured out that new vaccines and vaccine prevention support measures worldwide would help eliminate the outbreaks of bacterial meningitis by 2030. Vaccination against meningitis will protect adults and children fr om the infection that annually affects five million people and claims about 290 thousand lives worldwide. At the same time, a third of those who recovered still have severe<a href=\"https://www.mayoclinic.org/diseases-conditions/meningitis/symptoms-causes/syc-20350508\"> complications</a> such as hearing loss, memory problems, and mental impairment<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn1\"><sup><sup>[1]</sup></sup></a>.\n</p>\n<p>\n\t Domestic production of Menactra<sup>®</sup> is a crucial step forward in the collaboration between Sanofi Pasteur and Nanolek. Both companies are united by one common goal - protecting the Russian citizens, especially children, from vaccine-preventable infections. The localization of the five-component vaccine Pentaxim<sup>®</sup> by Sanofi Pasteur at the Nanolek plant in the Kirov Region is set to be completed as early as in 2022. Since 2017, the vaccine has been supplied as part of the National Vaccination Schedule.\n</p>\n<blockquote>\n\t<p>\n\t\t Denis Manturov, Minister of Industry and Trade of the Russian Federation:\n\t</p>\n\t<p>\n\t\t \"Course for localization of advanced unique foreign products that we have set when the Pharma-2020 Strategy was developed, has proven to be effective. We still welcome and support cooperation between Russian and foreign companies in projects to set up production of medicines in Russia. It is important to note that consistent measures to extend localization will ensure the transfer of new competencies, launch of new advanced production facilities and, eventually, will make the vaccine against meningococcal infection more affordable.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Frederic Jumel, General Manager at Sanofi Pasteur Eurasia:\n\t</p>\n\t<p>\n\t\t \"Meningococcal infection is associated with a high mortality rate and in many cases leads to disability and serious consequences. The epidemiological situation with respect to meningococcal infection in Russia is unpredictable; therefore, as many children as possible must be reliably protected against it. Sanofi Pasteur has taken another step towards this goal. We are currently expecting an increase in production, which can mainly be related to the outlook for adding meningococcal infection vaccines to the National Vaccination Schedule\".\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Vladimir Khristenko, President of NANOLEK LLC:\n\t</p>\n\t<p>\n\t\t “We are glad to take such an important step in the development of our partnership with Sanofi Pasteur, which allows us to use the latest vaccine production technologies in Russia. It is a great honour for us to work together in protecting children from dangerous infectious diseases.\"\n\t</p>\n</blockquote>\n<p>\n <b>Background Information </b>\n</p>\n <b> </b>\n<p>\n <b>\n\tAbout Menactra</b><sup><b>®</b></sup><b> vaccine</b>\n</p>\n<p>\n\t Menactra<sup>®</sup> - a polysaccharide conjugate vaccine for the prevention of meningococcal infections of four serogroups (A, C, Y, W) in children (nine months and older), adolescents and adults has been registered and used in Russia since 2014 (Registration Certificate LP-002636 of September 22, 2014)<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn2\"><sup><sup>[2]</sup></sup></a>.\n</p>\n<p>\n\t Over seven years wh ere the vaccine was used in Russia, much experience has been accumulated, and local data have been collected on its high immunogenicity and favourable safety profile in children, adolescents, and adults.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn3\"><sup><sup>[3]</sup></sup></a>\n</p>\n<p>\n\t According to the Headway Company report (2015–2021), Menactra<sup>®</sup> is supplied to 85 regions of the country to immunize children and adults; since 2014, more than 1.5 million doses have been used in various regions.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn4\"><sup><sup>[4]</sup></sup></a> The vaccine has been used worldwide for over 15 years<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn5\"><sup><sup>[5]</sup></sup></a> now, registered in more than 70 countries. More than 100 million doses have been produced so far<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn6\"><sup><sup>[6]</sup></sup></a>.\n</p>\n<p>\n <b>About Meningococcal Infection</b>\n</p>\n<p>\n\t The meningococcal infection is most common in children, adolescents, and young adults, and up to 70% of cases account for these age groups. Besides, the meningococcal infection leads to the severe generalized forms of infection (SGFI), high mortality (10-20% of SGFI cases) and a significant number of cases of disability after the disease (20-30% of those who suffered SGFI)<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn7\"><sup><sup>[7]</sup></sup></a>.\n</p>\n<p>\n\t The highest morbidity and mortality from SGFI is observed in children under the age of one. The incidence of MI in children from 0 to 4 years old exceed those in adults by about 25 times, even with timely diagnosis and the use of intensive, comprehensive treatment.<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn8\"><sup><sup>[8]</sup></sup></a>.\n</p>\n<p>\n\t Given the unpredictability of changes in the epidemiology of meningococcal infection in the Russian Federation, it is advisable to use modern conjugated meningococcal vaccines with the broadest coverage of serogroup pathogen for vaccination<sup>9</sup>. Such multicomponent conjugate vaccines are highly effective and have a good safety profile, therefore are widely used in many countries<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftn9\"><sup><sup>[9]</sup></sup></a>.\n</p>\n<p>\n <b>About Sanofi Pasteur</b>\n</p>\n<p>\n\t Sanofi Pasteur, the division of the Sanofi Group, is a world leader in human vaccine production and development. Sanofi Pasteur offers an extensive range of vaccines in the global market that includes drugs preventing against more than 15 viral and bacterial diseases. Every year, the company produces more than one billion doses of vaccines to immunize over 500 million people worldwide. For more than 100 years of history, the company's mission has remained unchanged and is aimed at protecting life and defending human health from infectious diseases. Every day, Sanofi Pasteur invests more than one million euros in research and development. Mono- and combined vaccines are registered in Russia to prevent dangerous childhood and adult infections: diphtheria, tetanus, pertussis, poliomyelitis, haemophilic infection type b (Pentaxim<sup>®</sup>, Adasel<sup>®</sup>), influenza (Vaxigrip<sup>®</sup>), viral hepatitis A (Avaxim 160<sup>®</sup>, Avaxim 80<sup>®</sup>), meningococcal infections (Menactra<sup>®</sup>).\n</p>\n<p>\n <b>About Nanolek</b>\n</p>\n<p>\n\t Nanolek was founded by Vladimir Khristenko and Mikhail Nekrasov back in 2011. It specializes in the production of import-substituting and innovative medicines, both of its own design and those developed in cooperation with international partners. Nanolek is one of the leaders in the production of paediatric vaccines in the Russian Federation. A total of 20 medicines are now in the Nanolek's portfolio. And 35 more are at various stages of preparation for release and will hit the market in the next five years. The Nanolek plant in the Kirov Region, which was set up in 2014, was built with an eye on the world's best practices and technologies. The production facility holds a GMP certificate and regularly undergoes quality audits performed by large international pharmaceutical corporations: the Nanolek plant produces pharmaceuticals in cooperation with companies such as Sanofi.\n</p>\n<p>\n <b>About Sanofi</b>\n</p>\n<p>\n\t Sanofi is a global biopharmaceutical company whose mission is to provide support to those who face various health problems. With our vaccines, we strive to protect people from diseases, and our drugs help to ease the course of many diseases and improve the quality of life of both patients with rare and common chronic diseases.\n</p>\n<p>\n\t More than 100,000 Sanofi employees in 100 countries work every day to turn scientific innovation into specific healthcare solutions.\n</p>\n<hr align=\"left\" size=\"1\" width=\"33%\">\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref1\"><sup><sup>[1]</sup></sup></a> Defeating meningitis by 2030: a global road map <a href=\"http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pd\">http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pd</a> (Date of the application: 29.09.2021)\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref2\"><sup><sup>[2]</sup></sup></a>Instructions for the medical use of Menactra<sup>®</sup> vaccines (Registration Certificate LP-002636 date of state registration - 22.09.2014, date of amendments to the registration certificate – August 12, 2020\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref3\"><sup><sup>[3]</sup></sup></a> O. A. Perminova, V. V. Romanenko, V. Y. Rodnikova and others. Epidemiology and preventive vaccination. 2020; 19(2): 70-78\n</p>\n<p>\n\t I. Ya. Izvekova, L. S. Namazova-Baranova, А. V. Gogolev and others. Epidemiology and preventive vaccination. 2018; 17(6):19-34\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref4\"><sup><sup>[4]</sup></sup></a> Headway Company report (2015-2021) <a href=\"https://www.hwcompany.ru/presscenter\">https://www.hwcompany.ru/presscenter</a> (as of March 1, 2021)\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref5\"><sup><sup>[5]</sup></sup></a> Food and drug administration (FDA). Vaccines, Blood, and Biologics: January 14, 2005 approval letter. <a href=\"http://wayback.archive-it.org/7993/20170723032519/\">http://wayback.archive-it.org/7993/20170723032519/</a> <a href=\"https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm131181.htm\">https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm131181.htm</a> (as of 01.03.2020)\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref6\"><sup><sup>[6]</sup></sup></a> Sanofi Pasteur. Focus on meningitis 2019. <a href=\"https://www.sanofipasteur.com/en/media-room/focus-on-diseases/meningitis/\">https://www.sanofipasteur.com/en/media-room/focus-on-diseases/meningitis/</a> (as of 01.03.2020)\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref7\"><sup><sup>[7]</sup></sup></a> Sadarangani M, Pollard AJ. Clin Microbiol Infect 2016; 11:S103-S112\n</p>\n<p>\n\t Pace D, Pollard AJ. Vaccine 2012; 30(Suppl. 2): B3-B9\n</p>\n<p>\n\t Sadarangani M, Pollard AJ. Neisseria meningitidis (meningococcus). In: Kliegman RM, editor. Nelson textbook of pediatrics. 20th ed. Philadelphia: Elsevier; 2016. p. 1356-1365\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref8\"><sup><sup>[8]</sup></sup></a>On the state of sanitary and epidemiological well-being of the population in the Russian Federation in 2020: State Report. М.: Federal Service for Supervision on Consumer Rights Protection and Human Well-being, 2021. 256 p.\n</p>\n<p>\n\t 9 SanPiN 3.3686-21 “Sanitary-epidemiological requirements in the prevention of infection diseases“\n</p>\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%A1%D0%B0%D0%BD%D0%BE%D1%84%D0%B8%20%D0%9F%D0%B0%D1%81%D1%82%D0%B5%D1%80%20%D0%B8%20_%D0%9D%D0%B0%D0%BD%D0%BE%D0%BB%D0%B5%D0%BA_%20%D0%BF%D0%BE%D0%B4%D0%BF%D0%B8%D1%81%D0%B0%D0%BB%D0%B8%20%D1%81%D0%BE%D0%B3%D0%BB%D0%B0%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BE%20%D0%BB%D0%BE%D0%BA%D0%B0%D0%BB%D0%B8%D0%B7%D0%B0%D1%86%D0%B8%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%BE%D1%82%20%D0%BC%D0%B5%D0%BD%D0%B8%D0%BD%D0%B3%D0%B8%D1%82%D0%B0_%D0%A4%D0%98%D0%9D%D0%90%D0%9B_en_re.docx#_ftnref9\"><sup><sup>[9]</sup></sup></a> Vaccines, 7<sup>th</sup> ed. / [edited by] Stanley A. Plotkin, Walter A. Orenstein, Paul A. Offit. Philadelphia, PA: Elsevier, 2018\n</p>\n <br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/40a/x_vot_etot_fayl.jpg"},{"tag":"COMPANY NEWS","title":"New Vaccines Are Created Here: The Nanolek R&D Centre Opens Up in Pushchino - a Science City Near Moscow","date":"20.09.2021","desc":"","link":"/en/news/companynews/new-vaccines-are-created-here-the-nanolek-r-d-centre-opens-up-in-pushchino-a-science-city-near-mosco/","inner_date":"20.09.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t September 20, 2021. The young pharmaceutical company Nanolek invested 50 million roubles in efforts to equip its first early development (R&D) centre and plans to invest 2 billion roubles by 2025 in the development of proprietary molecules for pharmaceuticals. In the laboratories of Pushchino Science City, a team of scientists has already begun working on five new molecules, including a combined coronavirus and flu vaccine.\n</p>\n<p>\n\t President of Nanolek Vladimir Khristenko and First Deputy Minister of Industry and Trade Vasily Osmakov cut the ribbon at the solemn ceremony of opening of the Nanolek R&D centre on Friday, September 17. The event was attended by the Minister of Investments, Industry, and Science of the Moscow Region Yekaterina Zinovieva, head of the Pushchino urban district municipality Alexei Vorobyov, Chairman of the Board of the Association of Pharmaceutical Manufacturers Stanislav Naumov, and representatives of the scientific community.\n</p>\n<p>\n\t The investments in laboratories’ equipping amounted to 50 million roubles. In total, Nanolek will allocate two billion roubles in the development of its medicines over the next five years.\n</p>\n<p>\n\t What is early development in pharmaceuticals from a business perspective? The path of medication from an idea to market entry takes up to six years, early development of one molecule takes 1–2 years, it requires investments of 15 to 50 million roubles. At that, only 10 molecule hypotheses on average out of 100 reach the market.\n</p>\n<p>\n\t It was no coincidence to choose this place: Pushchino Science City is Russia's most significant biological centre. Pushchino scientists annually publish more than 600 articles in international scientific journals (peer-reviewed magazines). The Nanolek R&D Centre began working at the premises of the Pushchino Institute of Biological Instrumentation of the Russian Academy of Sciences whose scientists focus on new methods and technologies in physicochemical biology, medicine, and pharmacology. The 2019 laureate of state prize in Science Andrey Ulitin was appointed its scientific director; candidates of biological sciences and senior researchers - experts in cell technology, cell biology, and genetic engineering joined the team as well. Svetlana Zakirova, Ph.D. in biology, Deputy General Director for R&D, will be responsible for management of the R&D centre and its integration into the Nanolek strategy.\n</p>\n<p>\n\t The new laboratory in Pushchino will focus on vaccines and monoclonal antibodies for the treatment of cancer. Both directions correspond to global trends: up to 80% of scientific works worldwide are now dedicated to cancer treatment, and the relevance of vaccines in a pandemic has grown exponentially. That being said, the health of humankind is threatened not only by the coronavirus: scientists know more than 1,000 little-studied infections, and vaccines against each of them can be created.\n</p>\n<p>\n\t Currently, the portfolio of the Nanolek R&D centre includes five types of drugs:\n</p>\n<p>\n\t ● multivalent vaccine against coronavirus and influenza;\n</p>\n<p>\n\t ● shingles vaccine (Herpes Zoster) – the shot is given to 50+ people; in Russia, there is no domestic vaccination of this type yet;\n</p>\n<p>\n\t ● two biosimilar monoclonal antibodies;\n</p>\n<p>\n\t ● one original monoclonal antibody.\n</p>\n<p>\n\t Quotes:\n</p>\n<blockquote>\n\t<p>\n\t\t Vladimir Khristenko, President of NANOLEK\n\t</p>\n\t<p>\n\t\t \"Investing in early development is extremely risky in pharmaceuticals. We decided to create our own R&D centre and develop our own medicines from scratch only after we have accumulated extensive competencies in production and transfer of technologies. In 2020, the company generated a revenue of 12.5 billion roubles and was added to the top five list of vaccine manufacturers for the National Vaccination Schedule. Now, about 20% of vaccines purchased under this program are provided by Nanolek. According to the company's new strategy, we plan to become a leader among vaccine manufacturers in Russia over the next five years, which means adding at least four new vaccines to our portfolio. And we cannot do this without our own early development centre as part of this plan.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Vasily Osmakov, first Deputy Minister of Industry and Trade of the Russian Federation\n\t</p>\n\t<p>\n\t\t \"Creation of entirely domestically produced original medicines is one of the priorities in development of the pharmaceutical industry. The Nanolek’s early development centre at the premises of the Institute of Biological Instrumentation of the Russian Academy of Sciences in Pushchino is an example of cooperation necessary for the pharmaceutical industry to move to a whole new level in terms of quality. The Ministry of Industry and Trade of the Russian Federation plans to continue support and stimulation of applied scientific research in pharmaceuticals as part of the Pharma-2030 strategy.\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Yekaterina Zinovieva, Minister of Investments, Science and Industry of the Moscow Region\n\t</p>\n\t<p>\n\t\t \"The Moscow Region is traditionally the centre of not only industry and investment activity, but also science. As many as 8 out of 13 science cities are located here. The Moscow Region also plays a leading role in terms of industrial volumes, with 59 industrial parks and five special economic zones. As far as pharmaceuticals is concerned, it is one of the fastest-growing industries in the region. Therefore, we welcome the opening of the Nanolek R&D laboratory here. This event is also important for the nation's economy as a whole since the center is expected to produce the substances, vaccines themselves, a «heart» of medicines\".\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Alexey Vorobyov, head of Pushchino urban district municipality\n\t</p>\n\t<p>\n\t\t \"Pushchino is a city known primarily for its scientific potential: our employees carry out unique research in the laboratories of research institutes, but we lack industrial scale production facilities. We have been waiting for a long time for Nanolek to open its centre here: this link to the industry will give a meaningful result both for our country and, of course, for our science city\".\n\t</p>\n</blockquote>\n<p>\n\t Background Information\n</p>\n<p>\n\t Nanolek Biopharmaceutical Company\n</p>\n<p>\n\t It was founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. It specializes in the production of import-substituting and innovative medicines, both of its own design and created with the involvement of international partners. One of the leaders in the production of paediatric vaccines in the Russian Federation. In total, Nanolek's portfolio includes 20 medicines. Another 35 drugs are at various stages of preparation for release and will be commercially available within the next five years. The Nanolek plant in the Kirov Region, which was established in 2014, was built with an eye to the world's best practices and technologies. The production facility holds a GMP certificate and regularly undergoes quality audits performed of large international pharmaceutical corporations: the Nanolek plant produces drugs in cooperation with such companies as Sanofi, Janssen, Merck.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a3b/TSRR.jpg"},{"tag":"COMPANY NEWS","title":"The Federal Antinomopoly Service (fas) approves the maximum sale price for Covidolek","date":"10.09.2021","desc":"","link":"/en/news/companynews/the-federal-antinomopoly-service-fas-approves-the-maximum-sale-price-for-covidolek/","inner_date":"10.09.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Federal Antimonopoly Service (FAS) has approved the maximum sale price for Covidolek at 2,916 rubles.\n</p>\n<p>\n\t RIA News: The Federal Antimonopoly Service (FAS) of the Russian Federation has agreed to fix the maximum sale price of Covidolek used to treat COVID-19, a package of 40 tablets will cost 2,916 rubles, an official from the authority said.\n</p>\n<p>\n\t The Federal Antimonopoly Service has approved the maximum sale price of Covidolek. The message says that a package of 40 tablets 200 mg each will cost 2,916 rubles.\n</p>\n<p>\n\t The agency announced that the drug is included in the list of vital and essential drugs (VED). \"The medication has antiviral effects and is used to treat COVID-19,\" according to the agency.\n</p>\n<p>\n\t In March 2021, the Ministry of Health of the Russian Federation approved the phase III of clinical research of Covidolek (favipiravir). The manufacturer is Nanolek. The clinical research is expended to be completed by December 31, 2022.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/c79/Kovidolek.jpg"},{"tag":"COMPANY NEWS","title":"Nanolek to allocate 10 million rubles for support of a cardiology center in the Kirov region","date":"02.08.2021","desc":"","link":"/en/news/companynews/nanolek-to-allocate-10-million-rubles-for-support-of-a-cardiology-center-in-the-kirov-region-/","inner_date":"02.08.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Nanolek donated a medication for the treatment of cardiovascular diseases to the Kirov Centre for Cardiology and Neurology.\n</p>\n<p>\n\t The Kirov Regional Clinical Center of Cardiology and Neurology, a municipal state-funded public health institution, is expected to receive 84 thousand packs of Nebivolol NANOLEK® 5 mg No. 30 (INN: Nebivolol) worth 10 million rubles. The drug has already arrived at the warehouses of the Kirov Regional State Unitary Enterprise \"Aptechny sklad\" .\n</p>\n<p>\n\t Nebivolol NANOLEK® is a third-generation cardioselective beta-adrenergic antagonist with vasodilator properties. It is used in arterial hypertension, coronary heart disease, angina of effort.\n</p>\n<p>\n\t In Russia, as elsewhere in the world, cardiovascular diseases are still the leading cause of morbidity and mortality, despite medical and preventive measures. According to Rosstat, deaths caused by cardiovascular causes have declined steadily since 2010: in 2017, 862,895, or 587.6 people per 100,000 population died of such diseases vs 1,151,917, or 806.4 people per 100,000 population in 2010. However, cardiovascular diseases (CVDs) are still the leading cause of death in Russia, accounting for almost half (47%) of all deaths.\n</p>\n<p>\n\t Patient health and safety is a priority for Nanolek that takes every effort to offer patients only high-quality medicines. Nanolek's primary mission is to protect lives and health of people by making the world's best technology available to everyone. The Nanolek's biopharmaceutical complex is located in the Kirov region, therefore it helps prevent and protect local inhabitants’ health and meet the current demand for medicines. The company has undertaken the obligation to deliver the medicines. Nanolek's initiatives comply with Article 2 of Federal Law No. 135-FZ of 11 August 1995 \"On charitable activity and volunteering\" and Article 582 of the Civil Code of the Russian Federation.\n</p>\n<p>\n\t The Biopharmaceutical Complex in the Kirov region has been producing Nebivololol-NANOLEK® 5 mg No. 30 since 2015. On average, 80,000 packages are produced per year.\n</p>\n<blockquote>\n\t<p>\n\t\t Dmitry Viktorovich Khrushch, Candidate of Medical Sciences, surgeon, senior medical manager at Nanolek:\n\t</p>\n\t<p>\n\t\t \"Beta-blockers are used in many cardiovascular disease treatment regimens. They have proven to reduce statistically CVD mortality rates, especially in older patients, as they target different links in pathogenetic processes. Beta-blockers are the \"gold standard\" in the treatment of cardiovascular diseases, have proven positive effects on the body and helped to save many lives.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Mikhail Sergeevich Nekrasov, General Director of Nanolek:\n\t</p>\n\t<p>\n\t\t \"Our company's mission is to save people's lives and health; something we do not just say, but work every day. Cardiovascular diseases are world’s No. 1 killer. That is why efficient drugs are the first-choise \"weapon\" in the hands of the Russian doctors who save our fellow citizens every day. By joining our efforts only we would be able to extend life expectancy in the population. We are glad to have the resources to help.\"\n\t</p>\n</blockquote>\n<p>\n\t For your reference:\n</p>\n<p>\n\t Arterial hypertension (AH, arterial hypertension, hypertension) is a long-term medical condition in which the blood pressure (BP) persistently exceeds 130/80 mmHg at physical and emotional rest and without exposure to any external factors.\n</p>\n<p>\n\t The prevalence of hypertension in the adult population is 30-45%. In Russia, prevalence of AH is slightly higher among men aged 25-65 years (up to 47% in some regions), whereas prevalence of AH among women is appr. 40%. Prevalence of AH increases with age and reaches 60% or more in those over 60 years of age. The number of people affected by hypertension is predicted to increase by 15-20% to almost 1.5 billion by 2025.\n</p>\n<p>\n\t AH is a higher risk for cardiovascular (myocardial infarction, stroke, coronary heart disease (CHD), chronic heart failure), cerebrovascular (ischaemic or haemorrhagic stroke, transient ischaemic attack) and renal (chronic kidney disease (CKD)) diseases as compared to other factors.\n</p>\n<p>\n\t An elevated blood pressure is the leading global cause of premature death and nearly 10 million deaths and more than 200 million disabilities worldwide.\n</p>\n<p>\n\t Source: \" Arterial Hypertension In Adults\" Clinical Guidelines. Clinical guideline developed by: All-Russian public organization \"Russian Society of Cardiology\". Approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation.\n</p>\n<p>\n\t Coronary heart disease (CHD) is myocardial damage due to impaired supply of blood through the coronary arteries (CAs). CHD occurs as a result of organic (irreversible) and functional (transient) changes.\n</p>\n<p>\n\t Coronary heart disease is the leading cause of CVD deaths. The annual CHD mortality rate in Russia is 27%. Importantly, 42% of all CHD deaths account for the working-age population. Patients diagnosed with stable angina are twice as likely to die of CHD as patients living without it. Meanwhile, only 40-50% of all CHD patients are aware of the disease they have and receive appropriate treatment, whereas 50-60% of cases go undiagnosed.\n</p>\n<p>\n\t The prevalence of angina as the most common CHD form in the population increases with age: from 5-7% in women aged 45-64 years to 10-12% in women aged 65-85 years, and from 4-7% in men aged 45-64 years to 12-14% in men aged 45-64 years.\n</p>\n<p>\n\t Source: \"Stable Coronary Heart Disease\" Clinical Guidelines. Clinical guidelines developed by: the Russian Society of Cardiology. Collaborators: National Society for the Study of Atherosclerosis, National Society of Atherothrombosis, Association of Cardiovascular Surgeons of Russia. Approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation.\n</p>\n<p>\n\t Nanolek is a state-of-the-art biopharmaceutical company, a leader in the production of pediatric vaccines in Russia. Vladimir Khristenko and Mikhail Nekrasov founded the company in 2011. The company focuses on the production of import-substituting and innovative drugs, both proprietary and co-developed with international partners. The portfolio includes vaccines, medicines for the treatment of HIV, cancer and orphan diseases.\n</p>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/8fd/x_vot_etot_fayl.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk, First Deputy General Director of Nanolek, speaks at the conference on COVID-19 organized by the All-Russian Union of Patients","date":"02.08.2021","desc":"","link":"/en/news/companynews/maxim-stetsyuk-first-deputy-general-director-of-nanolek-speaks-at-the-conference-on-covid-19-organiz/","inner_date":"02.08.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On July 21, Maxim Stetsyuk, First Deputy General Director of Nanolek, took part in the conference \"Development of the Vaccination Calendar under COVID-19 - Taking Care of Health and Longevity\", supported by Rossiyskaya Gazeta and the Ministry of Health of the Russian Federation. The conference was organized by the All-Russian Union of Patients (ARUP).\n</p>\n<p>\n\t The ARUP raises concerns about the deadlines set for the expansion of the national vaccination calendar: its upgrade is behind schedule even though the Immunoprophylaxis Development Strategy 2035 is already in place. Currently, the National Vaccination Calendar (NVC) includes 12 vaccinations instead of 15 recommended by the World Health Organization, and this number will not increase any time soon. Adult pneumococcal pneumonia vaccination is not expected to begin before 2025, whereas these efforts amidst the pandemic could provide additional protection for the elderly and those with chronic diseases, or with immunosuppression. Preventable outbreaks of diseases are an additional burden on health facilities that currently lack recourses for their operation.\n</p>\n<p>\n\t The conference partners include the Research Institute of Pediatrics and Child Health of the Central Clinical Hospital of the Russian Academy of Sciences, the Pirogov Russian National Research Medical University, the Sechenov First Moscow State Medical University, Federal Scientific Clinical Center for Children and Adolescents of the Federal Medical and Biological Agency of Russia, Federal State Budgetary Institution Central Research Institute of Epidemiology of Rospotrebnadzor. Everyone agrees that the NPVC and preventive vaccination calendar need to be extended for epidemic-related reasons. The process will also be supported as experts say by public awareness campaigns, training for medical staff and launch of domestic vaccines, one of which that was developed by Nanolek against HPV is expected to hit the market in 2024.\n</p>\n<blockquote>\n\t<p>\n\t\t \"I believe what we need to do here is to join forces: manufacturers need to show and tell people what facilities exist to produce vaccines, doctors need to tell would-be patients what are the potential consequences. Openness and trust are important in this regard. In Russia, the vaccination calendar is financed by the government while in many other countries people pay for their own vaccinations themselves. When a citizen gets vaccinated and pays for it out of his or her own pocket, he or she becomes more loyal to vaccination. If we look back in history, we find that in the past vaccines took decades to produce. Nowadays we can make them faster, in less than five years. The medical community tasking a manufacturer with specifications to develop a vaccine mission can be confident that it will be launched in two to three years: this is how long it takes to develop a vaccine from scratch, firstly, and secondly, to learn how to control the quality of the vaccine. Then a testing phase begins, and the first step in this direction is to make sure it is safe. We need to communicate these findings to people, so that all of us understand that any vaccine commercially available in Russia has passed a safety test,\" explained Maxim Stetsyuk, Executive Director of Nanolek. He also reminded of statistics: 1.5 million children die every year worldwide from vaccine-preventable infections, and vaccine prophylaxis for children under the age of 1 in low- and middle-income countries would inject more than $586 billion into the global economy.\n\t</p>\n</blockquote>\n<p>\n\t Maxim also told about bottlenecks in production: \"Our company decided that vaccine prophylaxis and immunobiological drugs would be our priority. We're working hard to develop modern vaccines that will be in good demand in the future. However, some vaccines, such as rotavirus and chickenpox vaccines, are difficult to produce. If you plan to build such manufacturing facilities, you need to be sure that this vaccine will be included in the vaccination calendar and that there will be a strong demand for it in the future. Otherwise, you wont’t be able to produce any other items in your plant. Here again, the Ministry of Health, the Ministry of Industry, the manufacturers and the medical community must all share responsibility.\n</p>\n<p>\n\t Based on findings of the scientific and practical conference, the All-Russian Union of Patients will prepare a Resolution with proposals on development of a national vaccine prevention system and submit it to the Russian Government.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/442/Maksim_vot_etot_fayl.jpg"},{"tag":"COMPANY NEWS","title":"Vladimir Khristenko, President of Nanolek, attends the Trust Summit organized by Boston Consulting Group","date":"29.07.2021","desc":"","link":"/en/news/companynews/vladimir-khristenko-president-of-nanolek-attends-the-trust-summit-organized-by-boston-consulting-gro/","inner_date":"29.07.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t How much does trust cost? Are there any tools to create it? How it works when there is a need to bring about commercial success? Can trust between business and government be built consistently?\n</p>\n<p>\n\t This is a complex and subtle topic that invites to an extended conversation. Such topics were discussed in mid-July at the online conference \"How Much Does Trust Cost?\" co-hosted by the Transforma1 media portal.\n</p>\n<p>\n\t The panelists were Marcos Aguiar, Managing Director and Senior Partner at Boston Consulting Group, Brazil; Andrey Sharonov, President of Skolkovo Moscow School of Management; Andrey Elinson, Managing Partner at A1 and Vladimir Khristenko, President of Nanolek.\n</p>\n<p>\n\t So, how much does trust cost? Vladimir Khristenko voiced his opinion: \n</p>\n<p>\n\t \"All of our company's activities are built on trust. I would say there are three audience levels that it targets: \n</p>\n<p>\n\t 1. Our partners, including international ones, which transfer technology to us. Our mission is to make the best technology available to everyone in our country, and we have built all of our progress in such a way as to bring those technologies to Russia. Large international companies are pretty hard and slow to join any partnerships as they have a lot of policies and in-house regulations. It’s difficult to stat that kind of partnership, but if you keep your commitments, you can stay there for a long time. This is a vital factor for business: in Russia, we all suffer from then situation when things change all the time. Indeed, the legislation is constantly changing, and long-term measures are hard to plan.\n</p>\n<p>\n\t 2. It is the nation that is a key partner in our operations. Not for nothing there is a Russian proverb \"trust but verify\". So the government says, \"Do it and don't worry about anything,\" but what we want that relationship is more specific, we want probably contracts with specific obligations binding on parties. It is in our interest to make a product that will be in demand, and it is in the government's interest to make sure that people do not suffer from terrible diseases. We hope that such a legal mechanism will be found shortly.\n</p>\n<p>\n\t 3. Finally, ordinary people decide which vaccine they should take or which vaccine should their children receive. In such cases, trust should be at its highest. There is not much trust in this regard among Russians since our people do not trust Russian-made medicines. And we are talking about very different people, with different backgrounds and levels of awareness. This, in turn, reflects on the COVID vaccination story, although in my opinion there are other aspects apart from trust in the product's quality. We need to secure a greater transparency about potential side effects since any drug has potential side effects, and nothing is wrong with that.\n</p>\n<p>\n\t On top of that, the regulatory system needs further strengthening and we have to explain to the general public that all businesses that exist in Russia comply with appropriate standards. Because these are the official standards we follow in our production facilities.\" \n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/cdc/VV.jpg"},{"tag":"COMPANY NEWS","title":"Developers of medical products for the treatment of sepsis and severe forms of COVID-19 raise 200 million rubles in investment for development purposes","date":"08.07.2021","desc":"","link":"/en/news/companynews/developers-of-medical-products-for-the-treatment-of-sepsis-and-severe-forms-of-covid-19-raise-200-mi/","inner_date":"08.07.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t July 8, 2021 Efferon managed to raise 200 million rubles in investments which were allocated by Fix Ventures IT, entrepreneur Dmitry Eremeev. As part of the deal, the company was valued at more than two billion rubles.\n</p>\n<p>\n\t The Efferon project was established in 2016 by Ivan Bessonov and Alexei Morozov, graduates of the Chemistry Department of Moscow State University named after M.V. Lomonosov. In 2019, the Efferon® LPS and Efferon® CT disposable hemosorption columns were granted a permission for clinical use in Russia. Resuscitators use Efferon solutions as part of the comprehensive therapy of sepsis, septic shock, and severe forms of coronavirus infection. These solutions are based on a genuine technology for producing highly effective polymer sorbents for extracorporeal blood purification.\n</p>\n<p>\n\t In 2020, Efferon entered into an agreement with the biopharmaceutical company Nanolek on collaboration efforts in the Russian market. The company is a resident of Skolkovo and the Moscow State University Science Park.\n</p>\n<blockquote>\n\t<p>\n\t\t Alexander Volchansky, General Director of Efferon JSC:\n\t</p>\n\t<p>\n\t\t \"We managed to set up a full-cycle production of a globally competitive product. We focus on the rapidly growing demand in the domestic market, export deliveries to Latin America, the European Union, the Middle East, and China. Therefore, the immediate aim for 2021 is to scale up our production. In this connection, we welcome our new partner, Fix Ventures, and are glad to team up with him\".\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Ivan Bessonov, technical director and co-founder of Efferon JSC:\n\t</p>\n\t<p>\n\t\t \"The global competitiveness of products like ours is evidential basis behind their purpose. It can be composed of two components. On the one hand, these are clinical research of a high level of evidence, like the LASSO multi-center randomized study initiated by us. On the other hand, it is \"real-world evidence\" and clinical research conducted in the form of \"global registers.\" We are confident that the competencies of the Fix Group in IT and big data analysis will help create a new value here both for our consumers and us. Our company needs advanced technology and continuous investment in research and development to stay ahead of the growing market. We plan to scale up investments in these fields further. In this matter, Dmitry Eremeev and I turned out to be like-minded people.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Dmitry Eremeev, Founder of Fix Ventures and Bank 131:\n\t</p>\n\t<p>\n\t\t \"We are pleased to support a new Russian start-up with a truly global product. The Efferon team has created and continues to improve solutions that are already saving and will help save the lives of many more serious patients. We believe in the excellent prospects of Efferon in the Russian and global markets. Fix Ventures intends to continue to support the company's growth in technological and financial perspective and its access to new markets and will keep investing in other fast-growing promising Russian companies.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Oleg Movsesyan, Director of the Science Park of Moscow State University:\n\t</p>\n\t<p>\n\t\t \"I would like to congratulate our residents on a new round of investments - I’m sure that soon we will get the first \"unicorn\" represented by Efferon in our innovative company development ecosystem. The company has gone over a comparatively brief period from scientific development to a certified medical device that can successfully compete with the best world counterparts. The Science Park assisted in the preparation and conduct of clinical research of columns, in cooperation with the physicians of the Moscow State University Medical Center and several Moscow hospitals - first of all, State Hospital No. 67 named after L.A. Vorokhobov. We will be happy to use our competencies and contacts to successfully promote the company's products in the world markets.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t Vladimir Khristenko, President of NANOLEK:\n\t</p>\n\t<p>\n\t\t \"It is important for us that Nanolek, which values its reputation and cooperates with the largest global pharmaceutical companies, has Efferon hemosorption columns in its portfolio. This is a completely Russian-made product with a solid evidence base, which is successfully used to treat sepsis. Over the past year, Efferon has quickly earned recognition from the leading resuscitators in Russia - it is used to treat severe forms of COVID-19. Since the pandemic, unfortunately, is not over yet, we are confident that this product will be in great demand. And we are ready to take active efforts for support of its development in the Russian market.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/c14/kardio.jpg"},{"tag":"COMPANY NEWS","title":"16,000 locally produced packages of a drug to treat multiple myeloma launched on the Russian market","date":"02.07.2021","desc":"","link":"/en/news/companynews/16-000-locally-produced-packages-of-a-drug-to-treat-multiple-myeloma-launched-on-the-russian-market/","inner_date":"02.07.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Nanolek has completed the first stage of localization of a drug to treat intractable forms of blood cancer\n</p>\n<p>\n</p>\n<p>\n\t 2.07.21 Russian biopharmaceutical company Nanolek has completed the first stage of localization of the drug Darzalex® (INN daratumumab) - the secondary packaging and quality control stage. Nanolek's partner in the project is Janssen, the pharmaceutical division of Johnson & Johnson LLC. Darzalex is the fourth drug in Nanolek's oncological portfolio, and this area is one of the priorities for the company. Darzalex® is localized at the Nanolek plant in the Kirov region, which operates in accordance with international GMP and ISO standards.\n</p>\n<p>\n\t “Since 2020, daratumumab has been included in the list of drugs for the treatment of diseases that belong to high-cost nosologies (HCN). According to our estimates, the annual demand for the drug under the HCN program is about 55,000 units per year. Nanolek will provide this entire amount, and, together with our partner, we are ready to scale up production to ensure access to this drug for all patients with multiple myeloma to whom it is indicated and for whom it is purchased under the program. We believe that localization is contributing and will contribute to the expansion of the drug's use in clinical practice,” says Vladimir Khristenko, President of Nanolek.\n</p>\n<p>\n\t Daratumumab is the first biological drug in its class to target the surface protein CD38, which is largely expressed on all myeloma cells, regardless of the stage of the disease. Globally, Darzalex® (daratumumab) has been approved for treatment in patients with multiple myeloma (MM) since 2016.\n</p>\n<p>\n\t In Russia, the drug was registered in 2017 as a monotherapy for adult patients with recurrent and refractory multiple myeloma who had previously received a proteasome inhibitor and an immunomodulatory drug, and who had experienced progression of the disease during the last course of treatment.\n</p>\n<p>\n\t Since 2019, the list of indications has been expanded, and the drug has been used for combination therapy in adult patients with MM, starting fr om the first line of therapy<sup>2</sup>.\n</p>\n<p>\n\t According to the results of clinical studies, daratumumab showed good tolerability (adverse events include infusion reaction and anemia, while patients, as a rule, do not have to interrupt therapy), as well as high clinical efficacy in all lines of MM therapy for adult standard and high risk patients, leading to a significant reduction in mortality in patients receiving daratumumab-based therapy regimens, which is in line with national policy priorities to reduce mortality and increase life expectancy. So, in patients who are not candidates for transplantation, the addition of daratumumab to the Rd regimen (lenalidomide, dexamethasone) according to the MAIA clinical trial in the 1st line of MM treatment provides a 5-year overall survival (OS) rate in 66% of patients, and MM recurrence, according to the POLLUX clinical study, a 3.5-year OS in 65%, a third higher than when using the Rd regimen<sup>3,4</sup>.\n</p>\n<p>\n\t The daratumumab therapy regimen in combination with VMP (melphalan, bortezomib, prednisolone) in the 1st line of MM treatment provides a 3-year OS in 78% of patients, an improvement of 40% compared to the VMP regimen<sup>5</sup>.\n</p>\n<p>\n\t And when using the DVd regimen (daratumumab, bortezomib, dexamethasone) in patients with recurrent MM, the 3-year OS is 61%, which is an improvement of 22% compared to the Vd regimen<sup>6, 7</sup>.\n</p>\n<p>\n</p>\n<p>\n\t On the availability of financing for malignant blood diseases\n</p>\n<p>\n\t In April - May 2021, the Mar Consult research company conducted a study among Russian oncohematologists. According to its results, 26% of oncohematologists reported difficulties with drug provision, and 29% of those surveyed believe that innovative treatments are not available in Russia. The All-Russian Society of Oncohematology Sodeystvie conducted a survey among 788 patients fr om 76 regions of Russia, which showed that since the beginning of the pandemic, more than 60% of patients find it difficult to see a doctor, and 75% have not received the necessary treatment. Furthermore, in the case of multiple myeloma, the patient is indicated drugs throughout their life.\n</p>\n<p>\n\t The localization of oncohematological drugs will help to solve the difficulties with the lack of drugs. Such projects are in line with the federal program National Strategy for the Fight against Cancer Diseases. At the second international Forum of Oncology and Radiology, the ex-Minister of Health of Russia Veronika Skvortsova said: \"Reducing mortality from cancer is top priority for the state, which involves not only the medical community, but also the authorities.\" According to the Minister of Health of the Russian Federation Mikhail Murashko, thanks to the federal project Fight against Cancer, in 2020 the cancer mortality rate was reduced by 1.5%.\n</p>\n<p>\n\t About multiple myeloma\n</p>\n<p>\n\t Multiple myeloma (MM) is an incurable malignant blood disease that begins in the bone marrow and is characterized by excessive proliferation of plasma cells. MM is the second most common malignant blood disease. Almost 29% of patients with MM die within one year of the diagnosis of the disease<sup>1</sup>.\n</p>\n<p>\n\t According to the National Cancer Institute (USA), this disease accounts for 1,8% of all oncological diseases, in Russia, in 2017, the number of patients with multiple myeloma was 2.78 per 100,000 people. This is the second most common tumor of the hematopoietic system ... According to the American Cancer Society, middle-aged and elderly people are at risk: only 1% of cases of the disease occur in patients under 35 years of age. In the N.I. Pirogov Russian National Research Medical University they believe that the emergence of new drugs and the possibility of the autologous transplantation of hematopoietic stem cells (auto-HSCT) have increased the chances of Russian patients with multiple myeloma of surviving five years: since 2000, it has grown from 21 to 48%.\n</p>\n<p>\n\t For information:\n</p>\n<p>\n\t Darzalex® is the first fully human monoclonal antibody that acts on the surface protein CD38, which is largely expressed on all myeloma cells, regardless of the stage of the disease. The innovative action mechanism of the drug Darzalex® involves several mechanisms that cause the rapid death of tumor cells. Darzalex® induces the destruction of myeloma cells due to CD38-mediated immune mechanisms (complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity and antibody-dependent phagocytosis), apoptosis and the modulation of the enzymatic activity of CD3852.\n</p>\n<p>\n\t Nanolek is a modern biopharmaceutical company founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. It specializes in the production of import-substituting and innovative medicines, both of its own design and developed with the involvement of international partners. It is a leader in the production of pediatric vaccines in the Russian Federation. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and orphan diseases.\n</p>\n<p>\n\t About Janssen, Johnson & Johnson Pharmaceuticals\n</p>\n<p>\n\t At Janssen, we are creating a future wh ere disease is a thing of the past. We are Johnson & Johnson pharmaceutical companies, and we are sparing no effort to make this future a reality for patients around the world. We are winning the fight against disease with cutting-edge science. We invent ways to help those who need help. We heal hopelessness with human warmth.\n</p>\n<p>\n\t We work in the areas of medicine wh ere we can bring the greatest benefit: cardiovascular diseases, immune-mediated diseases and metabolic disorders, infectious diseases and vaccines, diseases of the central nervous system, oncology, and pulmonary arterial hypertension.\n</p>\n<p>\n\t References:\n</p>\n<ol type=\"1\">\n\t<li>1. Online resource: <a href=\"http://cr.rosminzdrav.ru/#!/schema/122\">http://cr.rosminzdrav.ru/#!/schema/122</a>. Categories of clinical guidelines “Multiple myeloma. ID КР144, age category: adults”// Ministry of Health of Russia, 2020, accessed 27 May 2021</li>\n\t<li>Instructions for the medical use of the drug DARZALEKS, LP-004367 date of last update 05 December 2019</li>\n\t<li>Thierry Facon, Presented on ASCO 2021. Oral presentation. LB1901</li>\n\t<li><a href=\"https://www.ncbi.nlm.nih.gov/pubmed/?term=Bahlis%20NJ%5BAuthor%5D&cauthor=true&cauthor_uid=30352784\">Bahlis N.J</a><a href=\"https://www.ncbi.nlm.nih.gov/pubmed/?term=Bahlis%20NJ%5BAuthor%5D&cauthor=true&cauthor_uid=30352784\">.</a> et al. <a href=\"https://www.nature.com/leu/\">Leukemia. </a>2020 Jan 30. DOI: <a href=\"https://www.nature.com/articles/s41375-020-0711-6\">10.1038/s41375-020-0711-6</a></li>\n\t<li>Mateos M et al. Lancet 2020 Jan 11;395(10218):132-141.</li>\n\t<li>Spencer A, American Society of Hematology, 2017.</li>\n\t<li><a href=\"about:blank\">Katja C. Weisel,</a> Blood (2019) 134 (Supplement_1: 3192.<a href=\"https://doi.org/10.1182/blood-2019-123527\">https://doi.org/10.1182/blood-2019-123527</a></li>\n</ol>\n<p>\n\t \n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/38f/Dzhonson.jpg"},{"tag":"COMPANY NEWS","title":"Positive results were obtained for the drug Brukinsa (Zanubrutinib) in a comparative trial with Ibrutinib","date":"18.06.2021","desc":"","link":"/en/news/companynews/positive-results-were-obtained-for-the-drug-brukinsa-zanubrutinib-in-a-comparative-trial-with-ibruti/","inner_date":"18.06.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t BeiGene, manufacturer of Brukinsa® (zanubritinib), a drug approved for the treatment of relapsed, refractory mantle cell lymphoma in China and the United States, reported the results of a comparative trial with the drug ibrutinib from an interim analysis which confirms that Zanubrutinib has an improved safety profile and superior investigator assessed overall response in patients with relapsed, refractory chronic lymphocytic leukemia or small cell leukemia (CLL). In Russia, Brukinsa® (zanubritinib) is localized and represented by Nanolek, a BeiGene distribution partner. The drug under regulatory review for relapsed, refractory MCL in the Russian Federation with potential approval at the end of the 2021.\n</p>\n<p>\n\t BeiGene announced significant positive interim results from the ALPINE, a Phase 3 trial comparing anubritinib to ibrutinib in patients with recurrent or refractory chronic lymphocytic leukemia or small lymphocyte lymphoma. The interim analysis is based on a follow-up of 415 of 652 patients, each of whom has participated in the trial for at least 12 months.\n</p>\n<p>\n\t Brukinsa® (zanubrutinib) is under regulatory review for relapsed, refractory MCL in the Russian Federation with potential approval at the end of the 2021.\n</p>\n<p>\n\t Under a strategic agreement signed in 2020, Brukinsa® is represented in Russia and the EEC by Nanolek, which has exclusive rights to distribution, promotion, pharmacovigilance, as well as secondary packaging and release control for the drug.\n</p>\n<p>\n\t In the ALPINE study, in terms of the ORR (objective response rate) – an important indicator of efficacy for oncohematologists and the primary endpoint for the trial – zanubrutinib demonstrated superiority according to the investigator assessment of ORR compared to ibrutinib (p = 0.0006). • As assessed by independent review committee (IRC), zanubrutinib achieved a numerically higher than but not statistically significant ORR compared to ibrutinib.\n</p>\n<p>\n\t These results were reported in an oral presentation as part of the Presidential Symposium and featured during the congress press briefing at the 26th European Hematology Association 2021 (EHA2021) Virtual Congress, taking place virtually on June 9-17, 2021.\n</p>\n<p>\n\t The data for the second key study endpoints – progression-free survival in 652 patients – was immature at the time of interim analysis. Formal analysis will be performed when the target number of events are reached. The PFS rate at 12 months was 94.9% in the Zanubrutinib arm, compared to 84.0% in the Ibrutinib arm.\n</p>\n<p>\n\t The study also proved additional characterization of the safety of the drug. Compared to ibrutinib, zanubrutinib showed statistically significant lower risk of fibrillation, which is characterized by an irregular heartbeat and can lead to blood clots, stroke, heart failure, and other heart complications. So, consistent with previous clinical trials, Zanubrutinib consistently demonstrates a better safety profile compared to Ibrutinib.\n</p>\n<p>\n\t This is the second head-to-head comparison between zanubrutinib and ibrutinib conducted by BeiGene in its Phase 3 trials program.\n</p>\n<blockquote>\n\t<p>\n <b>Jane Huang, MD, Chief Medical Offer of BeiGene's Department of Hematology</b>, commented on the results: “Interim results from this head-to-head trial demonstrated that as a selective inhibitor, zanubrutinib provides benefits for patients and decreases the level of cardiac arrhythmia compared to Ibrutinib. The data from this interim analysis, in addition to zanubrutinib's extensive clinical testing program, provided us with important new information to support its benefit-risk profile.”\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t “By the end of 2021, Brukinsa® which is currently under regulatory review has the potential to be available in Russia for relapsed, refractory mantle cell lymphoma. Cooperation between BeiGene and Nanolek has made it possible to launch Russian localization of a new generation drug in the shortest possible time. The localization of the drug will be provided at the Nanolek plant in the Kirov region,” <b>said Anton Prozumentov, Head of Specialized Medicines Division, Nanolek.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t “This partnership with BeiGene kicks off the development of the company's portfolio of oncological drugs here in Russia,” <b>says Vladimir Khristenko, President of Nanolek</b>. “We are delighted that Brukinsa is proving to be a drug with compelling efficacy and an excellent safety profile – this gives more hope to patients who are dealing with a difficult cancer diagnosis.”\n\t</p>\n</blockquote>\n<h3>\nAbout the drug </h3>\n<p>\n <b>Brukinsa® (Zanubrutinib):</b> A small molecule inhibitor of Bruton’s tyrosine kinase developed by scientists at BeiGene, which is currently being developed in clinical programs around the world as a monotherapy or in combination with other drugs for the treatment of malignant B lymphocyte tumors. Mantle cell lymphoma is a malignant tumor from B-lymphocytes, cells of the immune system. It is classified as a so-called non-Hodgkin's lymphomas. This type of lymphoma is characterized by high aggressiveness, a short time to progression, and chemoresistance in the period of relapse. Most patients come to the attention of doctors already in the advanced stage of the disease. The estimated incidence of mantle cell lymphoma in the Russian Federation is about 1,030 new cases per year. Brukinsa® (zanubritinib) is currently successfully used in the United States, China, and Canada in the treatment of B-cell-derived lymphoma.\n</p>\n<p>\n <b>About the ALPINE trial</b>\n</p>\n<p>\n\t ALPINE is a Phase 3 randomized global trial (NCT03734016) that compares zanubrutinib and ibrutinib in previously treated patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL).\n</p>\n<p>\n\t In the study, 652 patients were randomized into 2 groups, the first receiving zanubrutinib (160 mg orally twice a day), the second receiving ibrutinib (420 mg orally once a day) until disease progression or unacceptable toxicity.\n</p>\n<p>\n\t The primary objective response rate (ORR) analysiswas assessed by the researcher and an independent expert committee (IEC) using the modified 2008 iwCLL guidelines – with the modification of lymphocytosis associated with treatment in patients with CLL and the Lugano classification for non-Hodgkin's lymphoma for patients with small lymphocytic lymphoma (SLL).\n</p>\n<p>\n\t Hierarchical testing was applied to prove that the drug was not inferior to the control drug in terms of efficacy and, according to the assessment of the researcher and the IEC, was superior to it in in terms of the objective response rate.\n</p>\n<p>\n\t Key secondary endpoints include progression-free survival (PFS), duration of response, overall survival, and incidence of adverse events. Research is ongoing, with pre-defined ORR and CAP endpoints to be assessed in a final analysis expected in 2022.\n</p>\n<p>\n <b>About BeiGene</b>\n</p>\n<p>\n\t BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are committed to expediting the development of our diverse pipeline of novel therapeutics through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for two billion more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit <a href=\"http://www.beigene.com\">www.beigene.com</a>.\n</p>\n<p>\n <b>About Nanolek</b><br>\n</p>\n<p>\n\t Nanolek is a modern biopharmaceutical company and one of the leading producers of pediatric vaccines in Russia. Founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. It specializes in the production of import-substituting and innovative medicines, including in-house developments and those created in collaboration with international partners. In addition to vaccines, the portfolio includes drugs for the treatment of HIV, cancer and rare diseases.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/b48/BeiGene.jpg"},{"tag":"COMPANY NEWS","title":"Nanolek launches the first phase of clinical trials of HPV vaccine","date":"11.06.2021","desc":"","link":"/en/news/companynews/nanolek-launches-the-first-phase-of-clinical-trials-of-hpv-vaccine/","inner_date":"11.06.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Biopharmaceutical company \"Nanolek\" was granted a permission by the Ministry of Health of the Russian Federation for clinical trials of the first phase of HPV vaccine. This vaccine is expected to become the first domestic HPV vaccine to hit the market in late 2024. The company is planning to invest appr. 2 billion rubles in its development and full production cycle.\n</p>\n<p>\n\t Nanolek is about to release the quadrivalent HPV [types 6, 11, 16, 18] recombinant vaccine in partnership with Kombiotech and purchase full rights to the product, vaccine has not received a commercial name yet. The vaccine will be tested on healthy adult volunteers, with the first phase of the clinical trial to begin in June 2021. During the trial, scientists will evaluate the safety, tolerability, and immunogenicity of the vaccine — the ability of an antigen to elicit an immune response regardless of its immune specificity.\n</p>\n<p>\n\t The German scientist Harald zur Hausen, who demonstrated that cervical cancer in females is caused by HPV, was awarded the Nobel Prize in Medicine in 2008. This spurred the development of vaccine programs: Currently, HPV vaccination is included in national vaccination schedules in 91 countries worldwide. It is used in the prevention of cervical cancer, rectum cancer, oral cavity and laryngeal cancer, genital cancer. Vaccination decreases the risk of certain cancer types by 90%. According to standard healthcare recommendations which are in place in European countries, the United States and Israel, children 9 years and older and adults up to 26 years of age get a vaccine.\n</p>\n<p>\n\t The vaccine developed by Nanolek is believed to become the first domestic HPV vaccine to substitute commercially available HPV analogues produced by Merck & Co and GlaxoSmithKline. Development of a cutting-edge HPV vaccine is consistent with the strategy for strengthening the preventive vaccination approach in the Russian Federation until 2035, which aims at adding more vaccines for children and adults to the National Preventive Immunization Schedule. HPV vaccination is expected to be included in the schedule in 2024.\n</p>\n<blockquote>\n\t<p>\n\t\t \"According to analysts, the economic burden of HPV-associated diseases exceeds 60 billion rubles, these data originate from Russia,\" says Vladimir Khristenko, President of Nanolek.\"A full-scale vaccination of children of both sexes reduces the losses related to a decline in the birth rate due to HPV, decreases the risk of cancer in whole and, as a consequence, cuts the treatment expenses incurred by the healthcare facilities.\"\n\t</p>\n</blockquote>\n<p>\n\t After rolling out the HPV vaccine, Nanolek will be able to supply all vaccination needs of the Russian Federation, depending on the adopted vaccination schedule. The company plans to invest about 2 billion rubles in its development and full-cycle production.\n</p>\n<p>\n\t In 2025, Nanolek intends to submit the vaccine to the WHO for re-qualification in order to produce and supply the vaccine to foreign countries. During this procedure, the World Health Organization evaluates additional clinical data obtained from testing and regular use of the vaccine, and verifies its safety and effectiveness.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d71/VPCH_MZ.jpg"},{"tag":"COMPANY NEWS","title":"President of Nanolek Vladimir Khristenko signs the Declaration of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union) at the Forum in St. Petersburg","date":"02.06.2021","desc":"","link":"/en/news/companynews/resident-of-nanolek-vladimir-khristenko-signs-the-declaration-of-the-afpeaes-association-of-pharmace/","inner_date":"02.06.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Today, the Nanolek executives \"have landed\" just for one day at the St. Petersburg International Economic Forum - the main business event in Russia, an economic forum held in St. Petersburg. The forum was kicked off with an important event for the pharmaceutical industry - the ceremony of signing of the declaration of the Association of Pharmaceutical Manufacturers AFPEAES, of which Nanolek is a member as well. The declaration on a unified policy in the field of development, production, quality control and monitoring of safety of medicines by the AFPEAES member companies was signed by the CEOs of 9 domestic full-cycle pharmaceutical companies, including by Vladimir Khristenko, President of Nanolek.\n</p>\n<p>\n\t The primary purpose of the document is to improve the confidence of patients and doctors in the quality of Russian medicines. Manufacturing companies overcommit to promote the implementation of a patient-centered approach in the healthcare system at all stages of the drug life cycle. The signatories of the declaration also undertake to implement and promote an ethical collaboration between domestic pharmaceutical manufacturers, medical and patient communities, and to improve monitoring facilities for better effectiveness and safety of drugs and medical technologies.\n</p>\n<blockquote>\n\t<p>\n\t\t \"Today, we have laid the groundwork for establishing an additional mechanism of how to respond to reports of adverse reactions to drugs fr om companies that have signed the declaration,\" said Stanislav Naumov, Chairman of the AFPEAES Management Board.\n\t</p>\n</blockquote>\n<p>\n\t Later that day, Vladimir Khristenko delivered a speech during a preventive immunization panel discussion at the \"Drug Safety\" forum, wh ere he confirmed the company's intention to launch the production of CoviVac vaccines (developed by the Chumakov Research Institute) - up to 5 million doses of this COVID-19 vaccine are expected to be produced from the end of summer till the end of 2021.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/30a/PMEF.jpg"},{"tag":"COMPANY NEWS","title":"The plant of Nanolek in Kirow Region is about to launch production of the third CoviVac vaccine","date":"26.05.2021","desc":"","link":"/en/news/companynews/the-plant-of-nanolek-in-kirow-region-is-about-to-launch-production-of-the-third-covivac-vaccine/","inner_date":"26.05.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On May 25, a delegation headed by Igor Vladimirovich Vasiliev, Governor of the Kirov Region, Vladimir Petrovich Sysolyatin, Acting Minister of Industry, Entrepreneurship and Trade of the Kirov Region, Alexey Vodovozov, a scientific journalist, medical blogger and a general practitioner, Svetlana Zanko, Head of the Atomic Energy Information Center, visited the cutting-edge and state-of-the-art plant of Nanolek in the Kirov region.<br>\n</p>\n<p>\n\t Danail Donchev, Head of the biopharmaceutical facility, conducted a biotechnological plant tour and showed the production of COVID vaccines.\n</p>\n<blockquote>\n\t<p>\n <b>Danail Donchev:</b>\"This summer, we are planning to launch the production of the third COVID vaccine (CoviVac). We expect to invest RUB 40 million in technology transfer and scaling and have planned to produce 5 million doses by the end of the year. Currently, CoviVac is filled in a test mode. Nanolek uses a traditional technology to produce this vaccine containing an inactivated virus that cannot cause a disease and triggers a potent immune response”.\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Igor Vasiliev, Governor of the Kirov Region:</b> \"We have a unique situation here in Russia because we have different vaccine options, unlike in other countries. We were the first to create a vaccine globally and maintain our own production facilities\".\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Alexey Vodovozov:</b> I very often hear from people: \"I think COVID is not going to hit me.\" We should make an effort to eradicate such wrongful concepts in Russians' minds. I myself have come successfully through COVID-19 a month ago, and I know that no one is immune to this disease. As far as vaccines are concerned, it is like a seat belt in a car. In a car crash, it may of course harm your body, but it will definitely save your life\".\n\t</p>\n</blockquote>\n<p>\n\t We would like to remind you that in March 2021 Nanolek joined the efforts of various expert teams to find ways to prevent the spread of COVID-19: During a press conference with Russian President Vladimir Putin, Minister of Industry and Trade Denis Manturov announced that Nanolek was chosen as an industrial partner for the production of CoviVac vaccines (developed by the Chumakov Research Institute).\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/fdd/Gubernator-25-maya.jpg"},{"tag":"COMPANY NEWS","title":"Nanolek will invest 5 billion rubles in the full production cycle and proprietary vaccine development by 2024 to become a leader in Russia's vaccine market","date":"19.05.2021","desc":"","link":"/en/news/companynews/nanolek-will-invest-5-billion-rubles-in-the-full-production-cycle-and-proprietary-vaccine-developmen/","inner_date":"19.05.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tBy its 10th anniversary, Nanolek, a biopharmaceutical company, announces a plan to invest 5 billion rubles over 3 years in its full-cycle vaccine production facility in the Kirov region and an R&D Center for Biotech Medicines in Moscow. These steps are to be taken to triple the current vaccine portfolio by 2025 and to make us the leading vaccine manufacturer in the Russian market.<br>\n <br>\n In 2020, Nanolek accounted for 20% of government vaccine purchases on the NPVC, the National Pediatric Vaccine Calendar. The state spent a total of 26.6 billion rubles on vaccines for the calendar, of which about 5.4 billion rubles on Nanolek's vaccines. The company currently supplies two vaccines to the NPVC: Polymilex, against polio, and Pentaxim (jointly with Sanofi), a five-component combination vaccine to prevent diphtheria, tetanus, pertussis, polio, and diseases caused by Haemophilus influenzae.<br>\n <br>\n The current vaccine portfolio must be tripled to significantly increase the volume of state purchases for the national vaccine calendar in 2025 and to take the lead among vaccine manufacturers. For this reason, Nanolek can no longer do without full-cycle production of vaccines and its proprietary R&D of Biotech Medicines. Over 5 billion rubles will be channeled into these areas in the next three years.<br>\n <br>\n \"Now we have our proprietary R&D and a full cycle only for solid dosage forms,\" comments Vladimir Khristenko, President of Nanolek. \"As for the full vaccine production cycle, we are only starting now. This year, we also began creating our proprietary centers for the early development of immunobiological medicines, the R&Ds in the area of biotech medicines. We organize them in partnership with the Institute of Biological Instrumentation with Experimental Production of the Russian Academy of Sciences (IBP RAS) in Pushchino and Sechenov MSMU in Moscow. The plan is to have four or five proprietary developed medicines in our portfolio in a few years. This is the only way for us to become the leader in the Russian vaccine market and to get a head start on global markets.\" He adds: \"We continue to evolve as part of our mission to protect lives and health by making the world's best technologies available.\"<br>\n <br>\n <br>\n Now, for Nanolek, the goal of tripling the vaccine portfolio means adding at least four more vaccinations.<br>\n <br>\n HPV vaccine. This year, Nanolek plans to begin Phase I clinical trials of an HPV vaccine, a human papillomavirus vaccine. A high HPV titer increases the risk of cervical cancer in women and laryngeal cancer in men dramatically. This front-line vaccination is a joint project with Combiotech, a research and production company. In Europe, Israel, and the United States, even adults are now receiving HPV vaccines once every five years, although the basic WHO recommendation is to vaccinate adolescents before they become sexually active. The HPV vaccination is expected to appear on the national immunization calendar in 2024.<br>\n Pneumococcal vaccine. Clinical trials have been completed, and a 13-valent pneumococcal vaccine is scheduled to hit the market next year.<br>\n Meningococcal vaccine. A joint project with Sanofi to transfer the production of a meningococcal vaccine is underway. From a five-year perspective, the two partner companies plan to deepen production of the vaccine against this life-threatening infection step-by-step.<br>\n 4 proprietary vaccines. Several immunobiological medicines are in the early stages of development at the new R&D center (based at IBP RAS in Pushchino and Sechenov MSMU in Moscow). This is a proprietary covid vaccine and has been in preclinical trials. In the early development stage is a vaccine molecule for the prevention of shingles caused by the herpes zoster virus; this vaccine should be given to people aged 50+. The company has not yet disclosed two other new vaccines it has started working on. The first proprietary vaccine will not hit the market until 2024.<br>\n Facts about Nanolek<br>\n <br>\n ● Nanolek has seen 10 billion rubles invested in it in the last 10 years. The company's plant in the Kirov region that opened in 2014 was built with an eye on the best international practices and technologies. A total of 25 medicines are now in the Nanolek’s portfolio, and 20 more are at various stages of preparation for release and will hit the market in the next five years.<br>\n <br>\n ● In 10 years, the company has produced 140 million packages of pills: they can pave the road from Kirov to New Zealand. Nanolek vaccines have also immunized 10 million children in Russia in the first ten years, making the company the country's sole manufacturer of polio vaccines now.<br>\n <br>\n ● The plant is not only GMP (good manufacturing practice) certified, but also has regular quality audits by major international pharmaceutical corporations: the Nanolek plant produces medicines in cooperation with Sanofi, Janssen, Merck and other companies.<br>\n <br>\n ● Nanolek has paid 0.5 billion rubles in taxes to the Kirov region treasury for 10 years and plans to pay another 0.4 billion in taxes in 2021 to all levels of the regional budgets.<br>\n <br>\n ● Last year, Nanolek showed a multiple of turnover growth: 12 billion rubles in 2020 up from 7.5 billion rubles in 2019.<br>\n <br>\n ● In early 2021, the Board of Directors approved a new business strategy for five years: the main focus is still the production of pediatric vaccines and medicines to treat severe diseases, as well as full-cycle import substitution in line with the objectives of the Pharma 2030 state program. The company's structure has evolved to have three divisions now: the first, the flagship division for vaccines, the second for specialized medicines (drugs for the treatment of orphan diseases and cancer), and the third for contract manufacturing.<br>\n <br>\n ● In March 2021, the company joined the coronavirus prevention task: during a live line with Russian President Vladimir Putin, Minister of Industry and Trade Denis Manturov announced that Nanolek had been selected as an industrial partner for the production of the CoviVac vaccine (developed by the Chumakov Research Institute). In mid-summer, the company's high-tech, modern plant in the Kirov region plans to start producing CoviVac so that it can produce 5 million doses by the year-end, cooperating with the Chumakov Institute.<br>\n <br>\n Background:<br>\n <br>\n Nanolek. A modern biopharmaceutical company, a leader in pediatric vaccine production in Russia. Vladimir Khristenko and Mikhail Nekrasov founded it in 2011. The company is specializing in the production of import-substituting and innovative medicines developed in-house as well as those developed jointly with international partners. The portfolio includes HIV, cancer, and orphan disease medicines, and, of course, the vaccines.<br>\n <br>\n Vladimir Khristenko. Co-founder of Nanolek. The President of Nanolek since 2015. In charge of the strategic development, the formation of a portfolio of medicines and interaction with international partners. Prior to joining the pharmaceutical industry, he had held senior positions in the ChelPipe Group — Chelyabinsk Tube-Rolling Plant. Vladimir Khristenko graduated from HSE with a degree in Finance and Credit; he is a PhD in Economics. In 2016, he was trained under the program ADP at University of Chicago Booth School of Business.<br>\n <br>\n Mikhail Nekrasov. Co-founder and CEO of Nanolek. He headed the construction of Russia's first GMP-certified pharmaceutical factory, which subsequently entered the Top 5 pharmaceutical manufacturers in Russia. Mikhail Nekrasov graduated from the Perm State Medical Institute. He is a full member of the Russian Academy of Natural Sciences, the Chairman of the Board of the Biopharmaceutical Cluster in the Kirov Region. The author of three books; has several patents in the field of medicine, with more than 30 scientific publications.<br>\n <br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/717/11111.jpg"},{"tag":"COMPANY NEWS","title":"At a Meeting with Russian President Vladimir Putin on March 22, Nanolek Confirms Its Plans to Produce 5 Mln Doses of CoviVac Vaccine by the End of 2021","date":"22.03.2021","desc":"","link":"/en/news/companynews/at-a-meeting-with-russian-president-vladimir-putin-on-march-22-nanolek-confirms-its-plans-to-produce/","inner_date":"22.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Today, during the meeting of Vladimir Putin with pharmaceutical companies, President of Nanolek, Vladimir Khristenko, confirmed that by the end of 2021, the company's plant in the Kirov Region plans to produce from 5 million doses of the CoviVac vaccine against the coronavirus.\n</p>\n<p>\n</p>\n<p>\n\t Khristenko added that within the framework of a strategic partnership with the RI named after Chumakov, Nanolek would invest 40 million roubles in technology transfer and scaling up of CoviVac production. The production of the vaccine will begin in the summer of 2021.\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t \"Fortunately, we had begun to prepare the line for the production of the vaccine against the coronavirus long before the pandemic. Together with the Research Institute named after Chumakov - the developer of CoviVac - we have been working on releasing a completely domestic inactivated polio vaccine for two years now. And we are lucky that the production of the CoviVac vaccine is carried out using practically the same technology,” <b>commented the President of Nanolek.</b>\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n\t The Nanolek plant in the Kirov Region, opened in 2014, was built with an eye to the world's best practices and technologies. The production holds GMP certificate and regularly undergoes quality audits of sizeable international pharmaceutical corporations: the Nanolek plant manufactures products for companies such as Sanofi, Janssen, Merck, and others.\n</p>\n<p>\n</p>\n<p>\n\t NANOLEK SUMMERY\n</p>\n<p>\n\t Nanolek is a modern biopharmaceutical company, one of the leaders in the production of pediatric vaccines in Russia. It was founded in 2011 by Vladimir Khristenko and Mikhail Nekrasov. The company specializes in the production of import-substituting and innovative medicines, both of its design and created with international partners' involvement. In addition to vaccines, the portfolio includes medications to treat HIV, cancer, and orphan diseases.\n</p>\n<p>\n</p>\n<p>\n\t Vladimir Khristenko. The co-founder of Nanolek. Since 2015, he has been the president of the company. V. Khristenko is responsible for strategic development, forming a portfolio of medicines, and interaction with international partners. Prior to joining pharmaceuticals, Vladimir Khristenko held executive positions in the Chelyabinsk Pipe Rolling Plant group of CTRP. Graduated from the Higher School of Economics with a degree in Finance and Credit, he has a Ph.D. in Economics. In 2016, Vladimir completed training for top management at the University of Chicago Booth School of Business.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/783/1111.jpg"},{"tag":"COMPANY NEWS","title":"Mikhail Nekrasov, CEO of NANOLEK, attends the XVI Annual Conference \"Pharmaceutical Business in Russia\"","date":"15.03.2021","desc":"","link":"/en/news/companynews/mikhail-nekrasov-ceo-of-nanolek-attends-the-xvi-annual-conference-pharmaceutical-business-in-russia/","inner_date":"15.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On March 11, 2021, Mikhail Nekrasov took part in the panel discussion \"PHARMA 2030 strategy: renewal effect.\" The discussion was moderated by Vladislav Shestakov (Head of the Federal State-Funded Institution \"Institute for Medicinal Products and Good Manufacturing Practice\"), and was attended by Alexey Alyokhin, Advisor to the Minister of Industry and Trade of the Russian Federation as well as representatives of pharmaceutical manufacturers and industry experts.\n</p>\n<p>\n\t Topics that were discussed: outlook for development of the Russian pharmaceutical industry for the next ten years, import substitution, development of export, refurbishment of Russian pharmaceutical enterprises, development of active pharmaceutical substances and immunobiological drugs, development of pharmaceutical clusters and staff related issues in the pharmaceutical industry.\n</p>\n<p>\n\t The pandemic revealed the necessity to move the immunoprophylaxis related issues to the forefront. The Strategy (approved by order of the Government of the Russian Federation No. 2390-r dated September 18, 2020) provides for measures to optimize the National Preventive Immunization Schedule and the calendar of preventive vaccinations as required by epidemic control guidelines.\n</p>\n<p>\n\t There are plans to add new vaccines for the prevention of rotavirus infection, chickenpox, human papillomavirus, meningococcal infection. The total economic damages caused by these infections amount to appr. 89 billion rubles.\n</p>\n<blockquote>\n\t<p>\n <b>Mikhail Nekrasov reminded:</b> \"Manufacturers of vaccines need to understand the way and time frame for the implementation of the Strategy in order to launch the production by the time specified in the document.\n\t</p>\n\t<p>\n\t\t The government has proposed measures to spur investments in industrial production in Russia, such as special investment contracts (SPIC), as well as subsidies provided to the manufacturers to cover parts of the costs in connection with the implementation of projects to set up production facilities and sale competitive drugs on their basis.\n\t</p>\n\t<p>\n\t\t Government support tool for SIC is sought after by manufacturers, however it has to be extended in terms of efforts to ensure guaranteed sales of vaccines.\"\n\t</p>\n\t<p>\n\t\t These measures will cover the population's needs for immunobiological drugs, and enhance the availability of high-quality, state-of-the-art and safe vaccines as part of public immunization schedules.\"\n\t</p>\n\t<p>\n\t\t \n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a9c/MS-11-marta.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk, First Deputy General Director of Nanolek, takes part in the scientific conference on COVID-19","date":"12.03.2021","desc":"","link":"/en/news/companynews/maxim-stetsyuk-first-deputy-general-director-of-nanolek-takes-part-in-the-scientific-conference-on-c/","inner_date":"12.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On March 11, the Committee of the Industry and Trade of the Russian Federation on Entrepreneurship in Healthcare and Medical Industry, the Commission of the Russian Union of Industrialists and Entrepreneurs (RSPP) on Health Industry, the RSPP Commission on Pharmaceutical and Medical Industry, and the Department of Medical Sciences of the Russian Academy of Sciences (RAS) held a joint meeting on the second day of the applied scientific conference \"Peculiarities of Immunoprophylaxis of Infectious Diseases during the COVID-19 pandemic.\"\n</p>\n<p>\n\t The panelists dwelled on the topic \"Vaccine prophylaxis and development of the national vaccine production. On implementation of the Coordination Plan to build facilities in Russia for full-cycle development and producion of vaccines included or scheduled for inclusion in the National Preventive Vaccination Calendar (NPVC) and Preventive Vaccination Calendar (PV) to meet epidemiological needs.\"\n</p>\n<p>\n\t The meeting was co-chaired by RSPP Executive Vice-President, Chairman of the RSPP Commission on the Health Industry Victor Cherepov, Chairman of the RSPP Commission on Enterpreneurship in Pharmaceutical and Medical Industry, Academician of the Russian Academy of Sciences Valery Sergienko, Chairman of the RSPP Commission on Pharmaceutical and Medical Industry, President of Rosmedprom Association Yuri Kalinin.\n</p>\n<p>\n\t Yuri Kalinin, Chairman of the RSPP Commission on Pharmaceutical and Medical Industry and President of Rosmedprom Association, made a keynote speech. He pointed out that more than ten national companies with all the scientific and other relevant competencies operate in the Russian market today. A significant shift has been taking hold on setting up a flexible production of vaccines for highly dangerous infections. Further efforts should be made to set up a state-of-the-art production of such vaccines according to current demands and ensure economic feasibility of production.\n</p>\n<p>\n\t Maksim Stetsyuk emphasized that clear deadlines for adding new vaccines to the NPVC list are highly important for vaccine manufacturers and that these deadlines should be anchored in legislation. This will help to timely set up a local production or develop the necessary vaccines from scratch. Long-term contracting is of utmost importance. Two-year vaccine supply contracts with the Ministry of Health have proven to be an effective tool which allows to evenly utilize production capacities by minimizing the risk of vaccine shortages in some regions.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/107/Maksim-farm-forum-24.11.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK continues to expand its portfolio of cancer drugs","date":"11.03.2021","desc":"","link":"/en/news/companynews/nanolek-continues-to-expand-its-portfolio-of-cancer-drugs-/","inner_date":"11.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<h1></h1>\n<h1></h1>\n NANOLEK was granted a market authorization for Rituximab (INN). The authorization was issued on February 11, 2021 by the Ministry of Health of the Russian Federation, for a period of 5 years, state registration # LP-006796.<br>\n <br>\n Obtaining a market authorization for this drug is one of the most important steps in the cooperation between NANOLEK and mAbxience (a global fully-fledged biotech company, with over a decade of experience in the development, manufacture and commercialization of biopharmaceuticals). The process of transferring the local production will make it possible to offer a Russian-made medicine to Russian patients.\n<h1></h1>\n<p>\n</p>\n<p>\n\t Rituximab is a chimeric mouse/human anti-CD20+ lymphoma monoclonal antibody. Rituximab specifically binds to the CD20 transmembrane antigen located on pre-B-lymphocytes and mature B-lymphocytes. Mechanism for Rituximab to function is effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the surface of granulocytes, macrophages and NK cells. Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.\n</p>\n<p>\n\t The level of circulating CD20+ B-lymphocytes decreases in both lymphoma and normal lymphocytes.\n</p>\n<p>\n</p>\n<p>\n</p>\n<p>\n\t The indications for the use of Rituximab are recurrent or chemoresistant B-cell, CD 20-positive non-Hodgkin's lymphoma with low malignancy or follicularity; follicular lymphoma stage III-IV combined with chemotherapy in patients previously untreated; follicular lymphoma as maintenance therapy after the response to induction therapy; CD 20-positive diffuse B-cell non-Hodgkin's lymphoma combined with CHOP chemotherapy; chronic lympholeukemia combined with chemotherapy in patients who have not received standard therapy before, and recurrent or chemoresistant chronic lympholeukemia combined with chemotherapy.\n</p>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b>\n\t</p>\n\t<p>\n\t\t \"NANOLEK develops its business in three key areas: vaccines, specialty care, contract manufacturing. Issuance of a market authorization for INN Rituximab and adding new drugs to the cancer portfolio is an important milestone not only for the company. Nanolek team has done a great job in helping even more patients to get access to high-quality and state-of-the-art therapy in the Russian Federation.\" \n\t</p>\n</blockquote>\n<h3>\nABOUT THE NANOLEK COMPANY </h3>\n<p>\n\t Nanolek is a modern, fast-growing Russian biopharmaceutical company with own high-tech full-cycle production according to GMP and ISO standards, which specializes in the production of import-substituting and innovative medications, both of its own form and those created with the involvement of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique technology transfer expertise in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.).\n</p>\n<p>\n\t Today, the company is one of the leaders in the production of pediatric vaccines in the Russian Federation. The NANOLEK company operates in the following areas: vaccines, specialty care, CMO.\n</p>\n<p>\n\t Nanolek LLC became the winner of the Platinum Ounce-2019 Award, in the Vector of the Year nomination, as part of the Project of the Year & Business Project sub-nomination. A laureate of the prize in the field of effective use of advanced technologies PRIORITY-2020 in the Localization of Production nomination for HANTERAZA medicine intended to treat Hunter's Syndrome. Nanolek took first place in the Fast-growing Large Companies Category of the TEKHUSPEKH-2020 Rating. It was also a participant in the priority project of the Ministry of Economic Development of Russia Support for Private High-tech Companies-leaders (National Champions) in 2017.\n</p>\n<p>\n\t On August 14, 2019, Nanolek LLC left the list of RUSNANO portfolio companies.\n</p>\n<p>\n\t In 2020, Nanolek LLC was included in the list of backbone enterprises of the Russian economy.\n</p>\n<p>\n\t The decision to include the organization in the list was made by the government commission to improve the sustainability of the Russian economy's development. The industry list was published on the website of the Ministry of Industry and Trade of Russia on April 25, 2020.\n</p>\n<p>\n\t \n</p>\n<h3>\nABOUT MABXIENCE</h3>\n<p>\n\t mAbxience is a fully integrated global biopharmaceutical company specialising in the development, manufacture and commercialization of monoclonal antibodies, and forms part of the pharmaceutical group Insud Pharma. Founded in 2010, mAbxience operates three state of the art facilities, located in Spain and Argentina. mAbxience is working on several biopharmaceutical products spanning to different therapeutic areas. In 2014 mAbxience launched its first biosimilar, Rituximab (Product Code: RTXM83-MB01), which is now approved and marketed in a range of markets worldwide.\n</p>\n<p>\n\t mAbxience is committed to the quality, safety and efficacy of its medicines. The mAbxience team is passionate about patient care and expanding access to its biopharmaceutical medicines all over the world. The Company's mission is to improve patient access to quality treatments for conditions that require costly medications and positively contributing to the sustainability of healthcare systems.\n</p>\n<p>\n\t The Insud Pharma group was founded by Dr. Hugo Sigman and Dr. Silvia Gold and has over 40 years' experience in the pharmaceutical sector and employs over 6,000 professionals worldwide.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/eb4/Rituksimab.jpg"},{"tag":"COMPANY NEWS","title":"Participants of PHARMA'S COOL-2021 SKOLKOVO dig into GMP standards","date":"05.03.2021","desc":"","link":"/en/news/companynews/participants-of-pharma-s-cool-2021-skolkovo-dig-into-gmp-standards/","inner_date":"05.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On March 3, 2021, Alexey Pavlov, Head of the Quality Management Department at NANOLEK, dwelled on the topic \"Production of pharmaceuticals. GMP standards\" when speaking before the audience of Pharma's cool Skolkovo.\n</p>\n<p>\n\t In his report, Alexey focused on the functioning of contract manufacturing. Valuable first-hand knowledge about regulations, documents, standards, and areas of responsibility is a serious and extensive topic, which is important for any specialist who has committed themselves to pharmaceuticals.\n</p>\n<p>\n\t In his speech Alexey elaborated on the importance of operational quality management at any pharmaceutical company and the significance of standards. The NANOLEK production complex stands as an excellent example of the successful application of GMP quality standards. The NANOLEK team has set itself ambitious goals to expand the product portfolio and introduce the latest solutions into production, performs socially significant projects, and believes its main mission is to protect people's lives and health - and this can be achieved only by maintaining tough requirements for the quality of products.\n</p>\n<blockquote>\n\t<p>\n <b>Alexey Pavlov:</b> \"A well thought-out quality management is extremely important, and it is strictly regulated by regulatory documents. Our company operates in compliance with international GMP standards and the ISO 9001 standard. As we cooperate with many international companies, we know for sure the importance of uniting people from partner companies into a single, well-functioning organism. Because in that event only a synergy is born that helps us move step by step towards the great goals.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f8e/Aleksey-farma.jpg"},{"tag":"COMPANY NEWS","title":"Marina Mazurevskaya, Deputy CEO for Legal Affairs and Government Relations Speaks at GR FORCE 2021 GR Director Forum","date":"04.03.2021","desc":"","link":"/en/news/companynews/marina-mazurevskaya-deputy-ceo-for-legal-affairs-and-government-relations-speaks-at-gr-force-2021-gr/","inner_date":"04.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On March 2, 2021, Marina Mazurevskaya, Deputy CEO for Legal Affairs and Government Relations, took part in the 5th Independent Professional GR Director Forum \"GR FORCE 2021. Transforming and Strengthening the Role of GR During and After the Pandemic\".\n</p>\n<p>\n\t The event brought together the pool of experts, heads of GR departments in large companies, to air the burning issues: what impact did the pandemic have and will have on GR as a trade, anti-crisis GR fundamentals during the COVID crisis, the ins and outs and distinctive features of remote GR, and evaluation and ways to increase efficiency of the GR department. The representatives of companies such as NANOLEK, NORILSK NICKEL, SRO MIR, VTB, BIOCAD, MTS and others shared their experience and insights into what was going on.\n</p>\n<p>\n\t GR directors of Russia's top companies discussed changes in the communication strategy to raise the efficiency of the GR function amidst the new reality, prepared forecasts on the political climate and development of GR trade in the near term, evaluated the efficiency of the lockdown campaign, the effects of legislative changes, the efficiency of communications with the government, dwelled on anti-crisis measures, remote and digital GR, and many other topics.\n</p>\n<p>\n\t Marina Mazurevskaya is in charge of GR, legal affairs, and the compliance system at NANOLEK. During her speech she told about her experience of interaction with the government authorities in the pandemic.\n</p>\n<p>\n\t Marina stressed that companies need to identify their strengths, work out proposals in line with the overall agenda and assess the risks in a time of crisis. A GR service is tasked with timely embedding initiatives in the agenda, responding to external challenges, and taking measures to ensure thorough monitoring of information and regulatory framework.\n</p>\n<p>\n\t The pandemic has raised the importance of the preventive vaccination across the globe. The vaccine-preventable diseases are a priority area for the biopharmaceutical company NANOLEK: BMC NANOLEK teamed up e.g. with Sanofi to produce a five-component pediatric vaccine in the Kirov region. Besides, NANOLEK is among the five manufacturing sites worldwide that are WHO-licensed\n</p>\n<p>\n\t for the production of inactivated polio vaccine to meet the needs of local markets. Vaccines against pneumococcal infection and human papillomavirus are now under development, besides we produce a few drugs listed in the Covid-19 recommendations.\n</p>\n<blockquote>\n\t<p>\n <b>Marina Mazurevskaya:</b> \"Most of the cases implemented in the Covid period suggest that the company has been proactive virtually through the entire pre-Covid time and that others know it as a trustworthy partner. I believe that an important task of every GR service is early identification of challenges, their digitalization, keeping track of possible deterioration of situation according to forecasts, and coming up with thought-out regulatory or managerial solutions.\"\n\t</p>\n</blockquote>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/28c/Marina-GR.jpg"},{"tag":"COMPANY NEWS","title":"Svetlana Zakirova, Deputy CEO for Development and Research at NANOLEK, delivered a speech at Pharma's cool in Skolkovo","date":"03.03.2021","desc":"","link":"/en/news/companynews/svetlana-zakirova-deputy-ceo-for-development-and-research-at-nanolek-delivered-a-speech-at-pharma-s-/","inner_date":"03.03.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t From March 2 to 5, Skolkovo hosts Pharma's cool - a unique educational intensive program focused on development and launch of new drugs to the market, a meeting place for industry leaders and young talents. This season saw a record number of applications for participation submitted – more than 2,500, 90 pharmaceutical market experts are planning to share their practices.\n</p>\n<p>\n\t Pharma's cool offers participants to take part in a professional dialogue with headline industry leaders, an access to a unique wealth of knowledge and insights, an opportunity to delve into the topic of innovative pharmaceuticals and main healthcare trends, find like-minded people, a place of internship and work.\n</p>\n<p>\n\t On March 2, Svetlana Zakirova, Deputy CEO for Development and Research at NANOLEK, told about current use cases in R&D during the session \"Hands-on experience in the development of preventive vaccines\". Apart from having extensive experience in large projects, Svetlana holds a PhD in Molecular Biology and Biotechnology.\n</p>\n<p>\n\t Her speech primarily focuses on vaccines. Svetlana spoke about new trends in vaccine prevention, scientific technologies, new approaches to vaccination, and emphasized the fact that vaccines are a priority area for NANOLEK playing a major role in its development strategy.\n</p>\n<blockquote>\n\t<p>\n <b>Svetlana Zakirova:</b> \"The annual Pharma's cool program is an excellent guide and a link between growing ambitious companies, such as NANOLEK, and the world of talented university graduates and young scientists. We have expertise, research and production capabilities, and young professionals get a technique how to gain knowledge in a biotechnology business. So why not take advantage of that? I'm open to discussion, please feel free to share your ideas, thoughts, suggestions with me personally. Let's chat and discover new things together!\"\n\t</p>\n</blockquote>\n<p>\n\t If you want to take part in the continuing discussion of this topic, do not hesitate to write a letter to Svetlana with your suggestion by clicking the QR code.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/b45/Svetlana.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK sums up the results for 2020","date":"26.02.2021","desc":"","link":"/en/news/companynews/nanolek-sums-up-the-results-for-2020/","inner_date":"26.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<h3>FIGURES<br>\n </h3>\n<p>\n\t · In 2020, the company’s earnings totalled appr. RUB 12 bn, which is 60% higher than in 2019 (RUB 7.5 bn).\n</p>\n<p>\n\t · Tax payments amounted to 548.6 million rubles, of which 225.9 million rubles - to the budget of the Kirov region, which is 2.5 times more than a year earlier.\n</p>\n<p>\n\t · The investment volume amounted to more than 828 million rubles, which is 66% higher than in 2019 (500 million rubles).\n</p>\n<p>\n\t · 8 new market authorization registration certificates were received (4 in the Russian Federation, 2 in the Republic of Belarus and 2 in Uzbekistan).\n</p>\n<h3>Partnerships</h3>\n<p>\n\t · At the end of March, NANOLEK and Efferon announced the launch of a strategic partnership for active roll-out of a special medical product, namely, Efferon sorption columns of 2 types. The device is used for extracorporeal blood purification and can also be used in the treatment of acute respiratory infection caused by SARS-CoV-2 (COVID-19).\n</p>\n<p>\n\t · In May, NANOLEK and KOMBIOTECH announced a long-term strategic partnership for the production of a fully domestic 4-valent vaccine against human papillomavirus (HPV) of 4 types (6, 11, 16, 18) which causes cervical cancer. According to the WHO, cervical cancer is the only cancer that can be prevented through primary prophylaxis - HPV vaccine.\n</p>\n<p>\n\t The drug will be manufactured at the full-cycle production facility of NANOLEK in the Kirov region. Preclinical studies were conducted in 2020. Clinical studies are expected to last until the end of 2022. Market authorization and start of production is scheduled for 2024\".\n</p>\n<p>\n\t · In May, NANOLEK and Sanofi announced a new stage in the development of a long-term partnership to set up a local full-cycle production in Russia to manufacture five-component combined pediatric vaccines developed by Sanofi, in particular, bottling of validation batches.\n</p>\n<p>\n\t · In mid-August Immolab, a subsidiary of Nanolek LLC, was granted a participant status in the Skolkovo project. Immolab will team up with the Innovation Center to develop a vaccine against COVID-19. The corresponding entry was added to the register on August 12, 2020.\n</p>\n<p>\n\t · In December 2020, the biopharmaceutical company NANOLEK and Sechenov University, one of the leading research universities in Russia, signed an agreement on a strategic and technological partnership in the development of immunobiological drugs. Intellectual and technical potential of the joint partnership will cover the entire range of activities to develop immunobiological drugs, including vaccines, starting fr om the creation of a drug concept to the production of finished products and preclinical trials.<br>\n\t This cooperation is expected to become the first step on the pathway of successful partnership between fundamental science and state-of-the-art production.\n</p>\n<h3>Vaccine business</h3>\n<p>\n\t · In 2020, the company continued strengthening its positions in the vaccine business, being NANOLEK’s priority. NANOLEK has started clinical trials of vaccines against pneumococcal infection in children. During the implementation of the project, a full-cycle production of vaccines will be launched in the Russian Federation. Pneumococcal infection occurs most commonly in children under the age of 5 years and in elderly people. Diseases caused by pneumococcus are dangerous and may lead to severe complications.\n</p>\n<p>\n\t · At the end of April, a small investment enterprise \"Invac\" - a joint venture of Nanolek LLC and the Federal State Budgetary Scientific Institution \"FNTSIRIP named after M.P. Chumakov of the Russian Academy of Sciences\"- submitted an application for market authorization of the first domestic Russian-made inactivated vaccine against poliomyelitis (PV). The market authorization will make it possible to uninterruptedly supply the Russian citizens with a highly effective and safe vaccine included in the list of the National Preventive Vaccination Schedule (NPVS).\n</p>\n<p>\n\t · In 2020, the first 2-year government contract (for 2019-2020) on supplies of vaccines according to the NPVS has been completed. Under the contract, NANOLEK has fully met all its obligations for the supply of a pediatric five-component combined vaccine (Pentaxim<sup>®</sup>) produced at the BMC NANOLEK. In total, 4 million doses of the vaccine were produced and delivered in 2020, which allowed to protect about 1 million children from five dangerous infections: tetanus, pertussis, diphtheria, poliomyelitis and hemophilus influenzae type b. Besides, as part of this contract, NANOLEK produced 3.2 million doses of inactivated polio vaccines in 2020, being the only manufacturer of this vaccine and one of the five sites recognized by the World Health Organization (WHO) as national manufacturers of inactivated polio vaccines.\n</p>\n<h3>Contract manufacturing</h3>\n<p>\n\t NANOLEK relies on the best domestic traditions and advanced Western technologies, an innovative approach to setting up production facilities, the conclusion of partnership agreements, development of pharmaceutical management. That is why large pharmaceutical companies opt for our production site in Kirov to produce their drugs. Currently, the largest contact production partner for NANOLEK is Merck (Concor and Glucophage are produced) . According to Merck experts, the NANOLEK production site is among the best contract sites of Europe.\n</p>\n<h3>Cost-demanding nosologies (VZN)</h3>\n<p>\n\t In 2020, NANOLEK won the tender and signed for the first time a direct contract with the Ministry of Health of the Russian Federation to supply Darzalex made by Janssen. NANOLEK is responsible for secondary packaging of this product.\n</p>\n<h3>\nCOVID-19 </h3>\n<p>\n\t NANOLEK, being a socially responsible company, took an active part in the fight against the pandemic.\n</p>\n<p>\n\t · An accelerated registration procedure helped NANOLEK to promptly release the first batch of hydroxychloroquine produced at the NANOLEK production site in the Kirov region. Hydroxychloroquine was adopted as a standard of care treatment protocol for COVID-19 patients in the temporary guidelines for the prevention, diagnosis and treatment of new coronavirus infection issued by the the Russian Ministry of Health.\n</p>\n<p>\n\t · NANOLEK has provided support to 16 medical centers in 8 regions of the Russian Federation. The company delivered free of charge medical masks, protective gloves, and disinfecting agents in order to build barriers preventing from the spread of SARS-CoV-2 among employees working with the state healthcare providers.\n</p>\n<p>\n\t Employees of the National Medical Research Center named after A.V. Almazov: “In these tough times, when doctors often risk their lives on the pandemic’s front lines, working to save patients, any aid is important. We are sincerely grateful to NANOLEK for care, attention and concerned approach“.\n</p>\n<p>\n\t · NANOLEK was awarded market authorizations for test kits to determine IgM and IgG antibodies against SARS-CoV-2 antigen in blood serum. Records RZN 2020/10959 (IgG) and RZN 2020/10963 (IgM) appeared in the register on the website of Roszdravnadzor. These are the first market authorizations of NANOLEK for medical devices.\n</p>\n<p>\n\t · NANOLEK and Efferon (members of the Moscow Innovation Cluster) donated hemosorption columns for the treatment of severe complications in patients with COVID-19 to the State Budgetary Healthcare Institution of Moscow City Clinical Hospital No. 40 in Kommunarka as well as to the coronavirus hospital housed by the university clinic - the Medical Scientific and Educational Center of Moscow State University on Lomonosovsky Prospekt. \"Efferon CT\" is intended to treat acute respiratory distress syndrome (severe lung damage in patients with pneumonia). The second column — \"Efferon LPS\" – can be used to purify blood in case of sepsis which can develop in a weakened body during long-term treatment and in cases wh ere artificial ventilation (ventilators) is used.\n</p>\n<h3>New market authorizations</h3>\n<p>\n\t · In mid-June, NANOLEK was awarded a market authorization by the Ministry of Health of the Republic of Belarus for the socially significant drug \"Hunterase\" for the treatment of mucopolysaccharidosis type II, a rare orphan disease. The authorization was issued for a period of 5 years. Earlier market authorizations for this drug were also issued in Russia and Kazakhstan.\n</p>\n<p>\n\t · Market authorizations for the drugs \"Nebivolol-Nanolek\" and \"Ramipril\" were issued by the Ministry of Health of the Republic of Uzbekistan. Market authorizations shall remain valid for a period of 5 years. The Republic of Uzbekistan became the fourth export country in a row in terms of delivery of various drugs.\n</p>\n<p>\n\t · NANOLEK was granted a market authorization by the Ministry of Health of the Republic of Belarus for Polimilex® - an inactivated vaccine for the prevention of poliomyelitis. The Republic of Belarus actively supports the poliomyelitis eradication program implemented by WHO, with the planned transition to the use of inactivated vaccines instead of live vaccines. According to experts of the Republic of Belarus, about 300 thousand doses of polio vaccine will be required for immunization of the relevant cohort of children.\n</p>\n<h3>Awards</h3>\n<p>\n\t · In June, NANOLEK won the Platinum Ounce-2019 All-Russian Open Competition for Pharmaceutical Market Professionals in the \"Vector of the Year\" nomination, \"Project of the year. Business project\" subnomination and received an award for the creation of the small investment enterprise \"Invak\" jointly with the Chumakov Scientific Center, which is set to produce vaccines at a full-cycle facility for immunization of the population of the Russian Federation as part of the NPVS. The first project of the small investment enterprise \"Invac\" was the production of fully domestic polio vaccines.\n</p>\n<p>\n\t · President of NANOLEK Vladimir Khristenko and executive director of the company Maxim Stetsyuk hit the ranking of the best managers in Russia, the Association of Russia’s Managers, and this for the second year in a row.\n</p>\n<p>\n\t The ranking includes leaders from different businesses, who have proven both their expert reputation and ability to meet the challenges of the time with their achievements.\n</p>\n Vladimir Khristenko was included in the Top 250 Managers list (by industry). Maksim Stetsyuk is in the Top-100 Commercial Directors list (by industry)\".<br>\n<p>\n\t · Upon the recommendation of the Ministry of Industrial Policy of the Kirov region, NANOLEK was added to the National Register \"Leading organizations of the industrial infrastructure of Russia.\"\n</p>\n<p>\n\t The register contains industrial companies that occupy leading positions in their industry and make a significant contribution to the socio-economic development of the region. An organization is added to the Register according to proposals from state and municipal authorities.\n</p>\n<p>\n\t · NANOLEK was added to the first Forbes' ranking \"Top Russian pharmaceutical companies\". The ranking includes the leading domestic pharmaceutical manufacturers. NANOLEK occupies the 19th place. The companies on a long list are assigned to the industrial sector “Production of drugs and materials used for medical purposes”.\n</p>\n<p>\n\t · NANOLEK CEO Maxim Stetsyuk won the Eurasian Pharma Award in the \"Commercial Success\" nomination. The competition is held in 2020 for the first time among pharmaceutical manufacturers of the Eurasian Union, the winners were selected from among 72 nominees from 13 countries, whose pharmaceutical markets are covered as part of the Eurasian Virtual Pharmaceutical Summit (Russia, Kazakhstan, Uzbekistan, Azerbaijan, Kyrgyzstan, Belarus, Armenia, Ukraine, Georgia, Moldova, Turkmenistan, Tajikistan, Mongolia).\n</p>\n<p>\n\t · In November 2020, NANOLEK won the PRIORITY-2020 award in the field of effective use of advanced technologies in the \"Localization of Production\" nomination for the drug used to treat the Hunter's syndrome - HANTERAZA.\n</p>\n<p>\n\t · In December, NANOLEK corporate media hit the top 3 list in the \"Silver Threads 2020\" contest: they took the second place in the category \"Best corporate account in social networks\" and the third place in the nomination of \"Best corporate magazine\".\n</p>\n<p>\n\t · Vladimir Khristenko, President of NANOLEK, is included for the second year in a row in the \"Choiseul 100 Russia\" ranking compiled by the French independent think tank Institut Choiseul.\n</p>\n<p>\n\t · For the second year in a row, NANOLEK ranked first in the TOP \"Fast-growing companies\" of the \"Techuspech\"-2020 ranking. Compared to the results of the 2019 ranking, NANOLEK improved its performance in two categories – in the Main ranking (“Large Companies”), moving up from 12th to 6th place and in the “Export potential” category, moving from 24th to 18th place.\n</p>\n<p>\n\t · In 2020, Nanolek LLC was included in the list of systemic companies in Russia. The decision to include the organization in the list was made by the government commission on improvement of sustainable development of the Russian economy. The industrial list was published on April 25, 2020 on the website of the Ministry of Industry and Trade of Russia.\n</p>\n<h3>Corporate social responsibility</h3>\n<p>\n\t · Nanolek LLC is a socially responsible company that pays great attention to the development of the Kirov Region. To date, the NANOLEK biopharmaceutical plant employs about 860 highly qualified workers, of which more than 200 employees are graduates of the Vyatka State University; 35% are experts in biotechnology.\n</p>\n<p>\n\t · Nanolek LLC is one of the founders of the industrial biotechnology cluster in Kirov region established at the initiative and with active participation of Igor Vasilyev, Governor of Kirov region. The main goal behind the creation of the research and education centre was to build a distributed scientific and production cluster, as a tool to achieve a global leadership in immunobiology, one of the most promising areas of world science. As part of its research and education activities, the center will be engaged in development of new drugs for epidemiological safety and medicinal independency of the country, development of innovative technologies to produce such drugs and develop projects for their implementation. An important part will be training and skills improvement of scientific, technological, managerial personnel as well as active international cooperation. An educational advanced training program has been developed together with Vyatka State University in order to train young professionals in biotechnology so that they subsequently have the opportunity to work at NANOLEK BMC.\n</p>\n<p>\n\t · In the context of cooperation between NANOLEK and VyatSU, the company holds Doors Open Days and organizes internships for students at the BMC. NANOLEK attracts university teachers to teach employees, develop and implement a VR training project, etc. In the summer of 2020, NANOLEK employees were members of the examination commission in defense of graduation projects prepared by VyatSU graduates.\n</p>\n<p>\n\t · NANOLEK is actively involved in charitable activities and provides assistance in accordance with the regulation on charitable activities:\n</p>\n<p>\n\t - provision of financial, social, volunteer and other assistance to people with disabilities (e.g., foundations, orphanages);\n</p>\n<p>\n\t - assistance in solving health issues (e.g., foundations, orphanages, medical institutions, etc.);\n</p>\n<p>\n\t - support of projects in the field of science and culture;\n</p>\n<p>\n\t - assistance to the leading specialized higher and other educational institutions.\n</p>\n<p>\n\t NANOLEK cooperates with the Regional Public Organization of parents of children with disabilities \"By the Way of the Good\", the Center for Curative Pedagogy, the Murygino orphanage, an orphanage in the village Spas-Talitsa, Orichevsky district.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f83/audit-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK and BeiGene: A Collaboration for Cancer Treatment in Russia","date":"25.02.2021","desc":"","link":"/en/news/companynews/nanolek-and-beigene-a-collaboration-for-cancer-treatment-in-russia/","inner_date":"25.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tNANOLEK and the global biotechnology company BeiGene have signed a strategic distribution agreement under which NANOLEK has acquired exclusive rights to the distribution, promotion, pharmacovigilance, and secondary packaging and release control of zanubrutinib, a drug sold under the brand name BRUKINSA®, in Russia and the Eurasian Economic Union (EAEU). <br>\n <br>\n NANOLEK has submitted documents to receive marketing authorizaton for BRUKINSA in the Russian Federation as a treatment for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.<br>\n <br>\n BRUKINSA (zanubrutinib) is currently approved in the United States and China for the treatment of certain patients with mantle cell lymphoma.<br>\n <br>\n<blockquote>\n\t “In NANOLEK we have found a distribution partner who we believe can professionally promote BRUKINSA (zanubrutinib) in Russia and across the EAEU. We value NANOLEK’s experience in working with global biotechnology companies and its particular expertise in promoting specialty care medicines. We are excited to work with NANOLEK in reaching our goal of developing and delivering impactful medicines that will be accessible to far more cancer patients around the world,” <b>said Todd Yancey, M.D., SVP of Global Medical Affairs & New Market Development at BeiGene.</b>\n</blockquote>\n <br>\n<blockquote>\n\t “Cancer diagnoses just keep on growing, but the number of people who get into remission and overcome this disease is growing as well. We are witnessing new generation drugs entering the market and providing treatment with fewer side effects. We are glad that BeiGene has entrusted us with its new product and we look forward to it soon becoming available to Russian patients. On the tenth anniversary of our company, this partnership is becoming even more important to us as in addition vaccines, we actively develop oncology segment”, <b>said Vladimir Khristenko, President of NANOLEK.</b>\n</blockquote>\n <br>\n<blockquote>\n <b>Stanislav Naumov, Chairman of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union:</b> “For most people, cancer is one of the most terrifying words of all. We are pleased to know that the state has made this a priority issue: the nationwide program “Fight Against Cancer“ is implemented as part of the National Healthcare Project and targeted at reducing the mortality rate from malignant neoplasms. On the other hand, members of our association are paying particular attention to the treatment of cancer. Collaboration between such innovative companies as BeiGene and NANOLEK represents one more step forward in the treatment of this disease, will increase the patient survival rate, and help overcome a popular opinion on cancer as a terrible and incurable disease.”\n</blockquote>\n<h3>Background information</h3>\n <br>\n BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists, that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. <br>\n <br>\n Mantle cell lymphoma is a B-cell lymphoma that develops from malignant B-lymphocytes of the immune system. It belongs to a group of diseases known as non-Hodgkin's lymphomas. This type of lymphoma is characterized by a particularly aggressive behaviour, short time to progression, and chemoresistance during relapse. Most patients are diagnosed in the advanced stage of the disease.<br>\n <br>\n BRUKINSA is approved in the United States as a treatment for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. <br>\n <br>\n BRUKINSA has received conditional approval from the in China NMPA for the treatment of MCL in adult patients who have received at least one prior therapy and for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in adult patients who have received at least one prior therapy. Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. <br>\n <br>\n Currently, more than 20 marketing applications for BRUKINSA have been submitted covering 45 countries and regions globally, including the United States, China, and European Union.<br>\n <br>\n The estimated incidence rate in the Russian Federation is about 1,030 new cases of mantle cell lymphoma per year.<br>\n<h3>ABOUT THE NANOLEK COMPANY</h3>\n <br>\n Nanolek is a modern, fast-growing Russian biopharmaceutical company with own high-tech full-cycle production according to GMP and ISO standards, which specializes in the production of import-substituting and innovative medications, both of its own form and those created with the involvement of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique technology transfer expertise in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.).<br>\n <br>\n Today, the company is one of the leaders in the production of pediatric vaccines in the Russian Federation. The NANOLEK company operates in the following areas: vaccines, specialty care, CMO.<br>\n <br>\n Nanolek LLC became the winner of the Platinum Ounce-2019 Award, in the Vector of the Year nomination, as part of the Project of the Year & Business Project sub-nomination. A laureate of the prize in the field of effective use of advanced technologies PRIORITY-2020 in the Localization of Production nomination for HANTERAZA medicine intended to treat Hunter's Syndrome. Nanolek took first place in the Fast-growing Large Companies Category of the TEKHUSPEKH-2020 Rating. It was also a participant in the priority project of the Ministry of Economic Development of Russia Support for Private High-tech Companies-leaders (National Champions) in 2017.<br>\n <br>\n On August 14, 2019, Nanolek LLC left the list of RUSNANO portfolio companies.<br>\n <br>\n In 2020, Nanolek LLC was included in the list of backbone enterprises of the Russian economy.<br>\n <br>\nThe decision to include the organization in the list was made by the government commission to improve the sustainability of the Russian economy's development. The industry list was published on the website of the Ministry of Industry and Trade of Russia on April 25, 2020.\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/721/BeiGene.jpg"},{"tag":"COMPANY NEWS","title":"Vladimir Khristenko, President of NANOLEK, took part in Health Tech Startup Show","date":"19.02.2021","desc":"","link":"/en/news/companynews/vladimir-khristenko-president-of-nanolek-took-part-in-health-tech-startup-show/","inner_date":"19.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t February 18, 2021 saw an event focused on protection of startups in Digital Health and preventive medicine. The event was organized by the venture studio LongLifeLab Ventures.\n</p>\n<p>\n\t The founders of startups presented their business ideas to an expert jury. The purpose of this event was to search for promising investment projects, therefore the jury was composed of businessmen having extensive experience in both entrepreneurship and investments:\n</p>\n<p>\n\t · Dmitry Pavlyuchenkov, strategic marketing and promotion specialist, consultant and businessman, ex-director of strategy and marketing at Internet Initiatives Development Fund (FRII),\n</p>\n<p>\n\t · Vladimir Khristenko, President of NANOLEK biopharmaceutical company, business angel,\n</p>\n<p>\n\t · Anton Gopka, venture capitalist and businessman, co-founder and general partner of ATEM Capital, a management company.\n</p>\n<p>\n\t The projects unveiled before the guests and experts included an AI-based service for diagnosing ENT patients with 95 percent accuracy; a project on the methodology of customer support and digital services that help customers manage their health online; a platform for remote personal and group training.\n</p>\n<p>\n\t Vladimir Khristenko also held a presentation at the event and told the guests about the structure of DIGITAL HEALTH. He dwelled on digital technologies that the pharmaceutical industry considers the most promising. Such technologies includes various vehicles (drones, self-driving cars), a blockchain (medical cards / medical history sheets, supply chain drugs, clinical trials), AR / VR (genome sequencing, genome editing, immuno-oncology, gene therapy), artificial intelligence (early development, diagnostics, patient monitoring), 3D printing (surgical instruments, devices, biomaterials), etc.\n</p>\n<p>\n\t The digital healthcare investment market as a whole (including venture capital funding, debt, and public offerings) doubled in 2020. This sector is expected to grow to USD 38 billion by 2025. In 2020, total investments in the industry, including venture capital financing and public offerings, amount to USD 21.6 billion (+103% growth by 2019).\n</p>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko:</b> \"The total investments in the digital health market in 2020 amounted to USD 22 billion in 600+ transactions from 900+ investors, 150 startups were granted funding. Demand for telemedicine has become the main growth driver: 41% of startups that received investments in 2020 offer solutions for remote access to medical services.\n\t</p>\n\t<p>\n\t\t The COVID-19 pandemic made of course a significant contribution to the dynamics, which increased demand for remote patient management, monitoring and diagnostics services. The industry experts believe that two areas have the greatest technological potential in the years to come: artificial intelligence and big data\".\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/4d0/VV-starapt-shou.jpg"},{"tag":"COMPANY NEWS","title":"Vladimir Khristenko, President of NANOLEK, takes part in the VIII Conference on Strategic Cooperation between Russia and Germany-2021","date":"17.02.2021","desc":"","link":"/en/news/companynews/vladimir-khristenko-president-of-nanolek-takes-part-in-the-viii-conference-on-strategic-cooperation-/","inner_date":"17.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tOn February 16, 2021, the Russian-German Chamber of Foreign Trade (CFT) supported by the Association of German Chambers of Industry and Commerce (DIHK) and the Representative Office of the German economy in the Russian Federation held an annual conference on strategic cooperation between Russia and Germany. <br>\n This year, the conference was held for the first time in online form and brought together more than 1,000 representatives of companies instead of the conventional 500 guests. The guests of the conference are representatives of political and economic circles.<br>\n <br>\n The participants discussed new ways to develop the Russian-German partnership, paid attention to the development of the Russian market, and identified opportunities to improve the Russia's investment image in Germany. <br>\n <br>\n The panel discussion \"Russia – innovations in the pharmaceutical industry\" was attended by Vladimir Khristenko, President of NANOLEK, and Philip Romanov (Head of the Department of State Regulation of Pharmaceuticals, Ministry of Health of the Russian Federation), Svetlana Gerbel (CEO at Siemens Healthineers Russia), Christian Macke (member of the Board at Berlin-Chemie AG), Miguel Pagan Fernandez, Chief Technology Officer at Stada.<br>\n <br>\n The participants discussed the promotion of innovations in the pharmaceutical industry, which was one of the first to embrace changes caused by the pandemic. Vladimir Khristenko drew attention to the fact that innovations in the pharmaceutical industry are developing in 3 directions. First of all, it is the production of vaccines and medicines, and the pandemic has accelerated this process. Secondly, it's an unprecedented production upscaling, when you need to produce several tens of billions of vaccine doses per year in a record time. This is an enormous challenge for manufacturers of equipment, auxiliary materials, and warehouses. Thirdly, innovations in the regulatory system which had to look for solutions to meet the challenge with appropriate speed.<br>\n <br>\n<blockquote>\n <b>Vladimir Khristenko answered the moderator's question about the partnership: </b>\"Since its foundation, NANOLEK has built its development on international partnership, while resting upon the \"win-win\" paradigm. You need to join forces to achieve the best results together, and NANOLEK offers first-class production and access to the Russian market. Our capabilities are constantly growing: thanks to the events happened in last year, we revised our development strategy and highlighted 3 main areas: vaccines, specialty therapies, and contract manufacturing, and we plan to greatly concentrate on R&D as well.\"\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/7a9/VV.jpg"},{"tag":"COMPANY NEWS","title":"Yulia Deeva, Director of Corporate Communications at NANOLEK, takes part in the V All-Russian Forum of PR Directors","date":"15.02.2021","desc":"","link":"/en/news/companynews/yulia-deeva-director-of-corporate-communications-at-nanolek-takes-part-in-the-v-all-russian-forum-of/","inner_date":"15.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t PR-FORUM 2021 primarily focuses on transformation of jobs and blurring of boundaries in the media environment. PR as a profession is a relatively young specialty that grows, develops and expands every day. New points of support, new meanings, new tools come in sight. And a new reality. This was especially true in 2020, when the world was on the verge of a pandemic and PR experts were faced with crisis communications.\n</p>\n<p>\n\t On February 10-12, 2021 the heads of PR departments of large companies in Moscow discussed the structure of integrated communications in B2B, talked about how to implement tasks in the digital environment during the pandemic and after it, and what new digital channels can be used in the PR of B2B companies. Besides, they brought down the nuances in the following topics: what really changed in communications and life in 2020; how to create a single tone of voice in communication with all target audiences, discussed the practices of promotion in various digital channels and other issues.\n</p>\n<blockquote>\n\t<p>\n <b>Yuliya Deeva:</b> \"Every crisis always creates opportunities, believe it or not. Even if the budget is trimmed, and the media space is distorted towards the agenda of others, you can always find an interesting content, audit possible partners and make joint projects, and the theory of small things and steps is always helpful: do not wait for any WOW events, even insignificant news will always find its audience.\n\t</p>\n\t<p>\n\t\t Despite the fact that I started a new field of activity just before switching to remote workng, it didn't prevent our team from \"making friends\" with the media, get on the top 3 list of corporate media and take part as experts in a huge number of online events.\n\t</p>\n\t<p>\n\t\t Never give up, but look around, create trends and learn from the strong leaders.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/392/YUliya-na-piar-forume.jpg"},{"tag":"COMPANY NEWS","title":"SKOLKOVO residents NANOLEK and Efferon sum up the results of work with Extracorporeal Blood Purification Devices: Efferon LPS and Efferon CT","date":"03.02.2021","desc":"","link":"/en/news/companynews/skolkovo-residents-nanolek-and-efferon-sum-up-the-results-of-work-with-extracorporeal-blood-purifica/","inner_date":"03.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t In April 2020, right at the peak of the pandemic, Nanolek LLC and Efferon JSC teamed up to launch two innovative devices for extracorporeal blood purification on the market: Efferon LPS and Efferon CT.\n</p>\n<p>\n\t Vast experience has been acquired in less than a year of collaboration on the use of hemosorption columns in patients with coronavirus infection, sepsis and septic shock.\n</p>\n<p>\n\t The physicians using Efferon LPS and Efferon CT columns in their clinical practice have shared feedback on their application and noted a positive dynamics of patients’ condition and safety of used treatment in severe patients.\n</p>\n<p>\n\t These findings have led to two publications in the \"General Reanimatology\" journal both focusing on the clinical use of the columns. The most recent one is dated December (<a href=\"https://www.reanimatology.com/rmt/article/view/1985\">https://www.reanimatology.com/rmt/article/view/1985</a>) and reports on the experience of using an Efferon LPS hemosorption column in 9 patients with septic shock which has proven the efficacy and safety of the technique. A 28-day survival rate was achieved in 7 of 9 patients, a figure that markedly improves the survivability rate in severe patients suffering from sepsis and septic shock.\n</p>\n<p>\n\t The multicentre randomised LASSO (Lipopolysaccharide Adsorption at Septic Shock) study organized by Efferon JSC on the premises of leading Russian medical centres will be launched in Q1 2021. The study is carried out according to GLP international standards and involves an independent contract research provider and a third-party laboratory facility.\n</p>\n<p>\n\t This year, in 2021, the NANOLEK team expects to roll out a mobile application to help medical practitioners use videos showing different modes of connection of devices to perfusion pumps. These videos enable to use the new device in daily practice of resuscitators and share personal experience of using extracorporeal techniques.\n</p>\n<blockquote>\n\t<p>\n <b>Artem Vetrov, Line Manager:</b> \"The NANOLEK team is not just seeking to promote the sales of Efferon absorption columns, but is rather aiming to put these techniques into service in healthcare institutions in Russia. The point is to show the medical community the applicability of Efferon devices in patients with sepsis and cytokine storm. Our first findings in the marketplace give us a positive outlook for the future, and we have absolutely no doubts that Efferon will be used in clinical practice as before.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Ivan Bessonov, Co-founder and Technical Director of Efferon JSC:</b> \"The results of the first year of our cooperation with NANOLEK are very satisfying for us. Their highly professional approach to promotion of our solutions on the market is what drives us to focus on research and development of new products which will be brought to the attention of the international medical community in the nearest future.\"\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n\t Please keep in mind that in 2020 Efferon and NANOLEK gratuitously delivered absorption columns to the state budget healthcare institution of Moscow \"City Clinical Hospital No 40\" in Kommunarka, a place treating patients with new coronavirus infection, the University Hospital - Medical Research and Education Center of Moscow State University on Lomonosovsky Prospect, and several other health care institutions.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/478/kardio.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Ranks First in the Top Fast Growing Companies of the TechUspech-2020 Rating for the Second Year in a Row","date":"01.02.2021","desc":"","link":"/en/news/companynews/nanolek-ranks-first-in-the-top-fast-growing-companies-of-the-techuspech-2020-rating-for-the-second-y/","inner_date":"01.02.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The annual business agenda begins routinely with the TechUspech rating. The main criteria to assess the level of success and technology performance of companies are the business size, innovation level and new products, the intellectual property that a company holds, and the demand rate for the products it sells in export markets, and more.\n</p>\n<p>\n\t NANOLEK has stepped up in two categories compared to the 2019 rating results: the Main Rating (\"Large Companies\"), going up from 12th to 6th place, and the \"Export Potential\" category, going up from 24th to 18th place.\n</p>\n<p>\n\t The annual TechUspech rating is founded by joint efforts of Russian Venture Company (RVC) and the Association of Innovative Regions of Russia (AIRR). It is meant to evaluate the innovative business potential of fast-growing high-tech companies with a high leadership potential on either the Russian or the global market.\n</p>\n<p>\n\t The TechUspech rating serves to spot the high-tech companies delivering the best results. These are also required to perform in a transparent way in daily operations, to apply best practices targeted at the further growth of the market, and to show that they are very innovation-driven. Companies join the rating to foster the growth of the Russian entrepreneurial community, boost performance and add to the investment attractiveness of the national market.\n</p>\n<blockquote>\n\t<p>\n <b>Mikhail Nekrasov, General Director of NANOLEK:</b> \"The high-profile competitions like this collect and analyze the achievements of Russian companies. So, it is a matter of importance and urgency to take part in them. This way we can witness the growth and advance, compare with the players of our industry and keep an eye on the market trends. We enjoy being at the top of the ratings, yet these are just numbers. Behind them stands our colleagues' selfless commitment, and we should bear this in mind. Receiving the news of the win amid the unfolding pandemic restrictions is doubly gratifying; we were able to ensure that the medicines to cure the new coronavirus infection were produced and delivered on time, and we continued to reinforce our position in the Russian and international pharmaceutical market. We thank the Expert Council for the high score it has given to NANOLEK's activities. It is an honorable thing to take the top line in the TechUspech rating. We are committed to reinforcing the role of the national pharmaceutical industry even further.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d25/Tekhuspekh.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK shares experience in how to apply mandatory labeling of goods","date":"27.01.2021","desc":"","link":"/en/news/companynews/nanolek-shares-experience-in-how-to-apply-mandatory-labeling-of-goods-/","inner_date":"27.01.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The conference \"Mandatory Labeling of Goods: Preparation and Implementation\" was held online on January 26, 2021.\n</p>\n<p>\n\t It brought together representatives from various sectors of the Russian economy. The transition to a mandatory labeling system has been underway for a fairly long time now, but the those involved in this process still face some difficulties and many issues require a collective mind and experience sharing.\n</p>\n<p>\n\t The best professionals and experts elaborated on whether various industries are ready to undertake mandatory product labeling: challenges, issues, and ways out. They shared how they manage the risks associated with the legislative aspects of product labeling and many other things.\n</p>\n<p>\n\t NANOLEK was among the first companies in the pharmaceutical segment to roll out “Labeling” project: on November 21, 2019, the BioMedical Complex in Kirov region issued a labeled commercial batch of Hunterase®, a medicine for the treatment of mucopolysaccharidosis type II, which is on the list of 14 high-cost nosologies.\n</p>\n<p>\n\t The panel session was attended by Alexey Ryzhy, Director of the Information Technology Department at NANOLEK, along with his colleagues from other companies: moderator Eduard Murakhovsky (Project Management Director, Pharmimex); Ilya Sadovenko (IT Director, Mary Kay Europe); Alexey Kadochnikov (IT Director, OTCPharm); Alexey Kuzmin (IT Director, GEROPHARM); Victor Dmitriev (CEO, Association of Russian Pharmaceutical Manufacturers (ARPM).\n</p>\n<p>\n\t The session focused on interacting with counterparties when introducing the labeling system. The experts talked about how market representatives are ready to handle labeled products, the major difficulties they face when dealing with the simplified labeling scheme for commodity balances, how to sell unlabeled balances, and how to assign a liability for labeled goods when selling goods through agents, and more.\n</p>\n<p>\n\t Alexey Ryzhy shared his practice of applying labeling specifically in pharmaceutics, given the challenging nature and many levels it has. This experience is a thing of value and use for the colleagues from other industries.\n</p>\n<p>\n\t Practice shows that assessing whether the market is ready for labeling before the system is launched is hardly possible: while the project has been in place since 2016 and was launched in June 2020, market players, even the operator, were not 100% ready for a large-scale launch. The best way to launch the system is to simplify it as much as possible and gradually build up the functionalities to the target level rather than expanding the most sophisticated and full version of the system to all market players straight away.\n</p>\n<blockquote>\n\t<p>\n <b>Alexey Ryzhy:</b> \"The framework that market players interact through the task group under Roszdravnadzor turned out to be incredibly effective. All those involved in the turnover, even representatives of the regulators (Roszdravnadzor, the Ministry of Industry and Trade, the Ministry of Health, the Federal Customs Service, etc.), were indeed given a chance to contribute to the growth of the system and address the toughest matters all by themselves very quickly. This is why we recommend that other industries and their respective regulators should set up the task groups of this kind.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bf4/Aleksey.jpg"},{"tag":"COMPANY NEWS","title":"Biopharmaceutical Company NANOLEK Receives a Registration Certificate for the Vaccine Outside of Russia for the First Time","date":"13.01.2021","desc":"","link":"/en/news/companynews/biopharmaceutical-company-nanolek-receives-a-registration-certificate-for-the-vaccine-outside-of-rus/","inner_date":"13.01.2021","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK received a registration certificate from the Ministry of Health of the Republic of Belarus for the POLIMILEX medicine - an inactivated vaccine to prevent poliomyelitis. The corresponding certificate No. 10881/20 was issued on December 15, 2020, for five years.\n</p>\n<p>\n\t Vaccination is one of the priority directions of NANOLEK's activity, constituting more than 40% of the total portfolio.\n</p>\n<p>\n\t In Russia, NANOLEK, together with the Dutch company Bilthoven Biologicals, launched a project for the phased transfer of the technology for the production of POLIMILEX - an inactivated vaccine for the prevention of poliomyelitis in 2012. Meanwhile, in 2017, the full-cycle production began (all stages, including quality control) at the NANOLEK production facilities in the Kirov Region. To date, production volumes fully cover the current needs of the Russian market. In the period from 2017 to 2020, as many as 10 million doses of vaccine were supplied for the National Vaccination Schedule of the Russian Federation. The full cycle production of the POLIMILEX vaccine has already proven its safety and high efficiency: the NANOLEK biopharmaceutical complex in the Kirov Region has international quality management certificates. It manufactures products under GMP standards. The production facilities make it possible to supply this vaccine for exportation.\n</p>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b>\n\t</p>\n\t<p>\n\t\t \"There is currently a shortage of inactivated polio vaccines on the international market. Being a socially responsible company, NANOLEK supports the global polio eradication program implemented by the WHO, with the planned transition to the use of inactivated vaccines instead of living ones. The Republic of Belarus is also concerned about this problem. According to experts of the Republic of Belarus, about 300 thousand doses of polio vaccine will be required\".\n\t</p>\n</blockquote>\n<p>\n\t Earlier, NANOLEK received a registration certificate from the Ministry of Health of the Republic of Belarus for the socially significant medicine Hunterase (Idursulfase beta) to treat a rare orphan disease type II Mucopolysaccharidosis and made the first shipments. The medication is produced jointly with Green Cross (Republic of Korea).\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d6d/Poli.jpg"},{"tag":"COMPANY NEWS","title":"Top 10 Highlights of the Pharmaceutical Industry according to APMEEU","date":"30.12.2020","desc":"","link":"/en/news/companynews/top-10-highlights-of-the-pharmaceutical-industry-according-to-apmeeu/","inner_date":"30.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The year just ending was a big challenge for all industries. Yet it was the pharmaceutical industry that had to rise to the task like no other. No wonder, it needs to operate cohesively for the sake of people's lives and health.\n</p>\n<p>\n\t The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (APMEEU) has now decided to take stock of the year and is pleased to share its summary of the most important events for the pharmaceutical market here.\n</p>\n<p>\n\t The pharmaceutical industry is one that has always been overly regulated and seen as conservative. This is why this year has been a breakthrough period in terms of legislative incentives. The relevant ministries have been working harder and faster on behalf of the state to take supportive decisions that are both unprecedented and crucial for this period.\n</p>\n<p>\n <b>1) The Government of the Russian Federation has adopted a procedure for faster registration of medical devices and granting approvals for the use of medicines to treat coronavirus patients and then extended it for a year.</b> The fast-track procedure allows one to have all the necessary documents for the use of medicines or medical devices in as short a time as possible. Specific circulation of medicines intended for use in the threat of an emergency and the prevention and treatment of diseases posing a danger to others have been approved by Government Resolution of the Russian Federation No. 441 of April 3, 2020. The special procedure was approved in April 2020 in the face of the COVID-19 spread. It now extends until January 1, 2022.\n</p>\n<p>\n <b>2) The Government of the Russian Federation has approved Resolution No. 1771 that establishes a special procedure for the re-registration of prices for the most demanded medicines on the VED list in the event of inventory shortage.</b> Roszdravnadzor (Russian Federal Health Care Supervisory Agency) is now bound by the new rules to monitor current shortages or risks of shortages of certain drugs due to pricing.\n</p>\n<p>\n <b>3) The Government of the Russian Federation has amended the VED List </b>\n</p>\n<p>\n\t (Decree of the Government of the Russian Federation No. 2626-p of October 12, 2020). The list is for an indefinite period now (the previous lists lasted for one year) and also has 3 coronavirus drugs on it. Today, the companies that are members of the Association produce 223 drugs on the VED list in a variety of nosologies.\n</p>\n<p>\n\t The pandemic has shown that immunoprophylaxis issues are coming to the fore. The WHO cites the failure to vaccinate as one of the top 10 threats to humanity. Immunization is lifesaving and cost-effective activity: 1 ruble put into vaccination equals 16 times the budgetary savings over time.\n</p>\n<p>\n <b>4) The Government of the Russian Federation has approved The Immunoprophylaxis Development Strategy for the next 15 years. </b>The document is commissioned by the President of the Russian Federation and sets out a roadmap until 2035. The strategy targets immunoprophylaxis for an array of infections such as diphtheria, measles, rubella, viral hepatitis B, and seasonal influenza. The actions of the strategy fall into six main areas.\n</p>\n<p>\n\t The first calls for the optimization of the national preventive vaccination and disease-specific vaccination schedules. It will list all vaccine-controlled infections exhaustively.\n</p>\n<p>\n\t The second is to foster scientific advances and pre-clinical research aimed at the creation of immunobiological medicines.\n</p>\n<p>\n\t The third is to localize the full cycle of vaccine production at domestic facilities.\n</p>\n<p>\n\t The fourth is to make immunizations safe and to ensure pharmacological follow-up of their results.\n</p>\n<p>\n\t The fifth is to perfect the state policy in the area of immunoprophylaxis of infectious diseases.\n</p>\n<p>\n\t The sixth is to raise people's awareness of the good things they can get from vaccination.\n</p>\n<p>\n <b>5) The world's first coronavirus vaccine, Sputnik V, has been registered in Russia.</b>\n</p>\n<p>\n\t A milestone this year was the full-scale introduction of labeling to help track the movement of medicines and to protect the end consumer while making the market perfectly traceable. APMEEU members are the first to launch drug labeling.\n</p>\n<p>\n <b>6) Labeling has been made binding for the pharmaceutical industry since July 1, 2020.</b> Some practical difficulties still arose, but now the Government Resolution PP No. 1779 of November 6, 2020, which is valid until February 2021, has put an end to all of them.\n</p>\n<p>\n <b>7) The implementation of the Pharma 2020 strategy has been summarized and Pharma 2030 has been put into action. </b>The Strategy has proven itself a success over the last 10 years, shaping the industry and paving the way for more than just bringing essential medicines to patients during a pandemic. The industry is better able to rise to the task, meet the challenge, and respond to difficulties as they arise. At the next stage, innovative development should become the main driver of Pharma 2030. This means that Russian companies must learn how to make modern high-tech drugs that will be copyright patented.\n</p>\n<p>\n <b>8) The Federal Centre for Planning and Organization of Drug Provision to Citizens was established on November 26.</b> Acting as a state customer, the institution will arrange for the procurement or acquisition of pharmaceuticals out of the federal budget funds as stipulated by Presidential Decrees, resolutions, and orders of the Russian Government, place state orders and award contracts, and arrange and hold the procurement of pharmaceuticals out of the federal budget funds, particularly for the treatment of people suffering from orphan diseases, cancer, HIV, tuberculosis. It will also cover immunobiological medicinal products for immunoprophylaxis aimed at giving prophylactic vaccinations listed in the National Calendar of Prophylactic Immunizations. Elena Maksimkina was appointed Acting Head of the Centre.\n</p>\n<p>\n <b>9) Shifting to the EEU Registration of Medicinal Products. </b>The changeover to common Union rules will let harmonize the standards between countries as well as move towards a more EU-like registration approach. The EEU registration makes the expert report of the regulatory body that contains the findings of the expert examination of registered medicinal products on crucial issues such as efficacy, safety, and quality open to the public. Hence, it is greatly transparent. This approach will bring the quality of the state expert examination of medicinal products to a higher level, which will ultimately have a positive effect on clinical practice.\n</p>\n<p>\n <b>10) Creation of a state fund to help orphan children. </b>The Russian Ministry of Healthcare has sent a draft list of diseases and medicines for treating them that the newly created fund would be able to finance to the Government.\n</p>\n<p>\n\t The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union was registered in 2012.\n</p>\n<p>\n\t The Association aims to create the framework for the pharmaceutical market of the Russian Federation and other EEU countries to build up, to reinforce the position and competitive performance of the national pharmaceutical industry.\n</p>\n<p>\n\t Members of the Association have the main competence centers, research laboratories, and production facilities among them, in the Russian Federation and other EEU countries. Likewise, they have proprietary know-how and other intellectual property in the development and production of medicines and medical technologies. The Association includes leading full-cycle pharmaceutical companies, namely: Pharmstandart PJSC, Biocad CJSC, GEROPHARM LLC, Nanolek LLC, Polysan, Science and Technology Drug Company, Aktivny Komponent JSC, Generium JSC, ChemRar, High Technology Center, NatiVita, JVLLC.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/6ce/AFPEES.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK and Its Charity: Doing Good Things","date":"30.12.2020","desc":"","link":"/en/news/companynews/nanolek-and-its-charity-doing-good-things/","inner_date":"30.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK sums up the results of the charity event to coincide with the New Year’s Day.\n</p>\n<p>\n\t On the eve of 2021, NANOLEK employees made the dreams of children fr om the Spas-Talitsky orphanage, children fr om the Muryginsky orphanage, and pupils of the “Walking the Path of Kindness“ center come true.\n</p>\n<p>\n\t For several years in a row, on the eve of the New Year’s Day, corporate Christmas trees of the NANOLEK biopharmaceutical complex and the company's Moscow office have been decorated with unusual charity cards. Each of them keeps the cherished New Year's wishes from orphanages’ children, who are helped by NANOLEK. Each employee can feel like a personal Santa or Ded Moroz (Russian Santa Claus), whichever they like best, and fulfil the child's dream. Everyone should get a bit of New Year's magic.\n</p>\n<p>\n\t By the end of the event, corporate \"Christmas Trees of Desires” brought together many beautiful gift bags and boxes in a festive wrapper! Despite working remotely, NANOLEK's employees actively participated in NanoSanta event, as in previous years. This is a road from a New Year's card with a child's cherished desire to its magic accomplishment.\n</p>\n<p>\n\t This year, this event expanded beyond the NANOLEK’s plant: it also involved regional employees working in different Russian cities. Besides, the role of NanoSanta’s was taken on by the partners of the company who saw a relevant announcement on social networks. There are no boundaries for good deeds, and on New Year's Eve, any miracles are possible!\n</p>\n<p>\n\t Thanks to the charity event organized by NANOLEK, as many as 190 small pupils from sponsoring organizations: the Muryginsky and Spas-Talitsky orphanages and RPOPCD (Regional Public Organization of Parents of Children with Disabilities) ”Walking the Path of Kindness” received precisely those New Year's gifts they have dreamed of.\n</p>\n<p>\n\t Gifts were presented in the Muryginsky orphanage as part of the holiday \"New Year’s Day without Borders\" also organized with the support of NANOLEK. It was conducted in compliance with all safety standards. It was clear that desire and imagination may help overcome any difficulties to allow children to celebrate a holiday, despite the pandemic.\n</p>\n<blockquote>\n\t<p>\n <b>Yulia Deeva, Corporate Communications Director at NANOLEK:</b> \"The most important thing is our joint contribution to the efforts to become a socially responsible business, build a culture of charity in society, maintain a kind-hearted attitude towards each other. NANOLEK is growing and evolving. We regularly launch new projects and employ new personnel. This means that we have a chance to involve even more activists in doing good things. Events like these help understand how important a personal level charity is for people.\"\n\t</p>\n</blockquote>\n<p>\n\t The NANOLEK charitable campaign was logically followed by the traditional congratulation of partners on the New Year holidays. This year, we have refused the idea of giving standard souvenirs and decided to purchase special meaningful gifts.\n</p>\n<p>\n\t Thanks to long-term cooperation with the Center for Curative Education, we got to know the \"Special Ceramics\" workshop, wh ere \"special\" people create ceramics. Their unique talent and creativity allow them to create exceptional items filled with warmth and love. Some of the corporate gifts were purchased exactly by this organization. The funds that were spent on products were used to support the Center for Curative Education.\n</p>\n<p>\n</p>\n<p>\n\t The second part of the gifts was ordered at an art workshop in Kirov, wh ere the Dymkovo toys are produced. The biopharmaceutical complex NANOLEK is located in the very heart of the Vyatka land, which is the birthplace of this industry. Therefore, we continued the symbolic activities of supporting the craftswomen who preserve traditions of cultural heritage and share the legacy of Russian culture with partners and pass on the age-old traditions that we love and are proud of.\n</p>\n<p>\n\t RHORDY “Walking the Path of Kindness”\n</p>\n<p>\n <a href=\"https://web.facebook.com/DorogouDobra/?__cft__%5b0%5d=AZVifjWlWaKU50xT7kjNWcKFoSSY-tpuwgnNjzgzgGdWGQ3UDSZs2xysJRXewUECOkAgPI0vhyeLPClkMYlaNLLYww7OceIvsEkNvf-NX5XyB9Q7PwdqS6Wae-2UX2vrWSW13p0HSxxOH7L7mVpdW1EU&__tn__=kK-R\">Regional Public Organization of Parents of Children with Disabilities ”Walking the Path of Kindness”</a>. Our goal is to unite families raising children with disabilities to protect their rights, improve the quality of life, and integrate them into society. Our mission is to unite parents of children with disabilities and specialists to protect the rights of families with special children, improve quality of their lives, and integrate into society <a href=\"https://rordi.ru/\">https://rordi.ru/</a>\n</p>\n<p>\n\t Center for Curative Education\n</p>\n<p>\n\t The Center assists children and adults with mental disabilities: autism, epilepsy, cerebral palsy, genetic syndromes, impaired intelligence, behaviour, and other conditions. Parents raising special children receive psychological, informational, and legal support at the Center. The Center has adopted a comprehensive approach to the rehabilitation and education of unique children. Our team is composed of 132 specialists: psychologists, neuropsychologists, educators, speech therapists, defectologists, game therapists, physicians, physical therapists, massage therapists, art therapists, lawyers, and social workers <a href=\"https://ccp.org.ru/\">https://ccp.org.ru/</a>\n</p>\n<p>\n\t Special Ceramics is a community of educators, volunteers, and exceptional staff (people with autism and other mental health disorders). These are people with impressive traits and talents, unique handwriting. For a special person to meet with the world and the world to meet a special person, you need to discover his ability to manifest himself in materials. In doing this, the ceramic artist helps him. The master selects a particular technology for each child to express themselves, while expanding the opportunities and skills of special workers <a href=\"http://o-keramika.ru/shop/\">http://o-keramika.ru/</a>\n</p>\n<p>\n\t The Dymkovo toys is a Russian folk craft, which originated in the 15-16 centuries in the Dymkovo village near the city of Vyatka (now it is the city of Kirov). Here comes the name - the “Dymkovo” or the “Kirov” toy. The Dymkovo toy is a human-made art. All patterns in the traditional Dymkovo toys are iconic, associated with nature and amulets. From sculpting to painting, this creative process never repeats. Each toy is unique in its way fashion. <a href=\"http://vyatskoeremeslo.ru/\">http://vyatskoeremeslo.ru/</a>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/6a1/NG.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK and Sechenov University: Science and Industry are meant to go hand in hand","date":"25.12.2020","desc":"","link":"/en/news/companynews/nanolek-and-sechenov-university-science-and-industry-are-meant-to-go-hand-in-hand/","inner_date":"25.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Sechenov University, one of Russia's leading research universities, and the biopharmaceutical company NANOLEK have entered into a strategic and technological partnership to develop immunobiological medicines. \n</p>\n<p>\n\t Among other things, the parties have agreed to work together on a range of cutting-edge medicines that can compete on global markets by being innovative and technologically advanced.\n</p>\n<p>\n\t The intellectual and technology capacity of the joint partnership will cover the entire cycle of immunobiological drug development; this will include vaccines, fr om drug concept development to finished products and pre-clinical trials.\n</p>\n<p>\n\t At BIOTECHMED 2020 Forum, <a href=\"https://minzdrav.gov.ru/news/2020/10/16/15209-mihail-murashko-prinyal-uchastie-v-konferentsii-biotehmed-2020?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+minzdravsocRF+%28%D0%9C%D0%B8%D0%BD%D0%B7%D0%B4%D1%80%D0%B0%D0%B2%29\">Health Minister Mikhail Murashko</a>\n\tsaid that science, practical skills and production would have to co-exist in the country so as to secure the advancement of new technologies.\n</p>\n<p>\n\t The cooperation will be the first step in a partnership between the fundamental sciences and advanced industry at a successful scale.\n</p>\n<blockquote>\n\t<p>\n <b>Petr Glybochko, Rector of Sechenov University, RAS Academician, </b>\"Sechenov University is on its way to becoming a world-class university, with a focus on multidisciplinary education, research and bringing developments into healthcare practice. We build on our competencies by creating innovative medicines, contributing to the quality of life and health of people, and to the economic empowerment of the country through access to export markets. It is now that cooperation between Sechenov University and NANOLEK takes on particular relevance. The pandemic has made us aware of the very real biological threats and has highlighted the need to get prepared for them in advance. It has become clear that the success of this challenge requires an interplay of science and industry, along with a willingness to digitise medicine and industry.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK,</b> \"The joint efforts of our colleagues at Sechenov University and NANOLEK will, I am sure, make it possible to reach a new level of interaction between science and industry very quickly. Our collaborative project fits perfectly into the concept for the 2035 Infectious Diseases Immunoprophylaxis Strategy approved in late September. Science is going ahead very rapidly, and the entire scientific and production capacity must be deployed to achieve the objectives outlined in the strategy. NANOLEK has biotechnology competencies and strong production capacity under GMP standards wh ere fully domestic, innovative immunobiological medicines can be produced.\"\n\t</p>\n</blockquote>\n<h3>\nAbout Sechenov University </h3>\n<p>\n\t Sechenov University is a centre of academic, scientific and resource excellence in Russia's healthcare system and is training future leaders in national and international healthcare. The mission it pursues is to create favourable climate for medical education and science to secure Russia's rightful place in the global healthcare system. The University provides a full cycle of educational programmes for the most talented students internationally. It is a leader when it comes to creating and implementing effective multidisciplinary medical education models and methodologies. It trains qualified medical personnel for Russia, the CIS and non-CIS countries in line with the best international practice. Member of the International Association of Universities. \n</p>\n<p>\n\t The University engages in world-class basic and clinical research and fosters its commercialisation towards better patient and community health. It develops the unique clinical base of its own, provides highly qualified medical care in Russia using cutting-edge science and technology; it is an active contributor to the effective fight against dangerous diseases internationally. \n</p>\n<p>\n\t It is currently listed in all international rankings of higher education institutions. \n</p>\n<p>\n\t Rector of the I.M. Sechenov First Moscow State Medical University, Academician of the Russian Academy of Sciences, Professor Pyotr V. Glybochko. \n</p>\n<p>\n <a href=\"https://www.sechenov.ru/\">https://www.sechenov.ru/</a>\n</p>\n<h3>\nAbout NANOLEK</h3>\n<p>\n\t NANOLEK is a rapidly growing forward-thinking Russia-based biopharmaceutical company with its own high-tech GMP and ISO-compliant full-cycle production facilities, targeted at import-substitution and innovative medicines, whether developed in-house or created with international partners, with a focus on the prevention and therapy of diseases of high social relevance. The Company is uniquely experienced in technology transfer via partnerships with the world's leading pharmaceutical companies (Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.). Nanolek LLC was ranked first in the Fast Growing Large Companies category of the TEKHUSPEKH 2019 rating. Nanolek was even a participant in the Ministry of Economic Development's priority project \"Supporting Private High-Tech Companies Leaders\" (\"National Champions\") in 2017.\n</p>\n<p>\n\t Today, the company is a leader in the production of paediatric vaccines in the Russian Federation. NANOLEK's versatile product portfolio offers the following therapeutic areas: vaccines, HIV drugs, cancer drugs, etc.\n</p>\n<p>\n\t On August 14, 2019, Nanolek LLC withdrew from ROSNANO's list of portfolio companies.\n</p>\n<p>\n\t In 2020, Nanolek LLC was added to the list of backbone enterprises of the Russian national economy. The decision to add the company to the list was made by a government commission on improving the sustainability of the Russian economy. The industry list was published on the website of the Russian Ministry of Industry and Trade on April 25, 2020.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/0ad/Sechenova.jpg"},{"tag":"COMPANY NEWS","title":"The round table 'Immunoprophylaxis as a Shared Concern of the People and the State' brought together a wide range of contributors to find out how to build a meaningful dialogue with different population groups","date":"17.12.2020","desc":"","link":"/en/news/companynews/the-round-table-immunoprophylaxis-as-a-shared-concern-of-the-people-and-the-state-brought-together-a/","inner_date":"17.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The reality in which we find ourselves in 2020 has made it clear that vaccine prophylaxis is a vital aspect of the healthcare system and is a common cause that must link government, research centers, and manufacturers in a holistic way, as well as involving the community as the main consumer, each one of us. Should one participant drop out of the system or not be fully involved in it, the system will cease to function.\n</p>\n<p>\n\t This topic was the core of the discussion: how to engage people and inspire their trust, and what conditions and actions are needed to do so. Experts joined the online panel to speak about the ways to communicate the benefits and safety of vaccine prophylaxis to the general public. The speakers were <b>Elena Baibarina</b> (Director of the Department of Child Health and Childbirth Services), <b>Marina Fedoseenko</b> (Associate Professor of Pediatrics at the Faculty of Pediatrics of the Pirogov Russian National Research Medical University), <b>Yan Vlasov</b> (All-Russian Union of Patients), <b>Tatiana Butskaya</b> (Chair of the Russian Mothers Council), <b>Evgenia Kudashova</b> (Head of Public Health and Medical Prevention Centre, Voronezh State Medical University named after N. N. Burdenko) and others. \n</p>\n<p>\n\t Immunoprophylaxis is a public health priority. While experts are working to improve and expand the National Preventive Immunisation Calendar, public health awareness activities need to be stepped up.\n</p>\n<p>\n\t The event was moderated by <b>Alexander Plakida</b>, Executive Director of the Effective Healthcare Platform of RANEPA, Adviser to the Vice-Rector of RANEPA. He suggested that, on the one hand, the past decade and the performance of Pharma 2020 have shown how much has been done by key players in the pharmaceutical industry and, on the other hand, the results have enabled new challenges to be outlined for the future horizon. Optimization of the National Preventive Immunisation Calendar should be the basis for implementing the Strategy 2035 objectives.\n</p>\n<p>\n\t This calendar should include vaccines to prevent rotavirus, chickenpox, human papillomavirus, and meningococcal disease, as well as expanded vaccination of all infants against Haemophilus influenzae type b, inactivated polio vaccines for all newborns, and pertussis revaccination.\n</p>\n<p>\n <b>Maxim Stetsyuk, Executive Director of NANOLEK</b>, shared what helps NANOLEK gain credibility for its products: \"We try to be clear and consistent in telling people about our work, our partners, and our production site. We stand for openness in the market and giving full information about the products on all platforms accessible, including social media.\"\n</p>\n<p>\n\t Maxim also referred to the foreign trend towards digitalization which the Russian industry is gradually adopting and which will make it possible to trace the whole route of an individual vaccine bottle from a production site to a particular child. When patients see that the manufacturer takes full responsibility for the quality of its products, they will have more confidence in vaccination on the whole,\" said Stetsyuk.\n</p>\n<p>\n <b>Marina Fedoseeva</b>, Ph.D., Associate Professor of Pediatrics at the Faculty of Pediatrics of the Pirogov Russian National Research Medical University, believes that vaccination education cycles are highly important and that these should be given to students at higher education institutions and those in the workforce regularly. \"The poor communication of vaccination messages to different categories of patients is a major problem for the professional community worldwide,\" stressed the expert.\n</p>\n<p>\n <b>Evgenia Kudashova</b>, Ph.D., participant in the ''Woman Leader'' program, head of the Centre for Public Health and Medical Prevention (in Voronezh), winner of the ''Health Care'' track, super finalist in the ''Leaders of Russia 2020'' competition, says that raising awareness of the benefits and necessity of vaccination is important; employers can help organize educational modules for adults, with a special focus on women, since women are known opinion leaders on health in their families. This kind of project is scheduled to start. The first phase of the project aims to build motivation, while the second phase is to help people meet the deadlines and specifics of their customized vaccination schedule through the latest software solutions such as smartphone apps.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/2e8/RBK-M-St.jpg"},{"tag":"COMPANY NEWS","title":"Top manager of NANOLEK speaks about the pharmacoeconomics of innovative drugs for the treatment of genetic and orphan diseases","date":"15.12.2020","desc":"","link":"/en/news/companynews/top-manager-of-nanolek-speaks-about-the-pharmacoeconomics-of-innovative-drugs-for-the-treatment-of-g/","inner_date":"15.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t December 10 and 11, 2020 saw an open, hybrid academic and research forum \"The latest genetics. Current state of knowledge about human diseases, promising approaches in health care\" (based on the example of orphan diseases).\n</p>\n<p>\n\t The event was held as part of the \"All-Russian Pharmaceutical Rally\" and is expected to become an annual event that brings together experts, manufacturers, representatives of science and patient organizations for exchange of ideas on the advances of orphan medicine, treatment of \"rare\" patients, development of a knowledge-intensive system for diagnosis and prevention of the spread of hereditary diseases, ways to regulate innovative technologies and organize medical care for people suffering from life-threatening, and rare (orphan) diseases.\n</p>\n<p>\n\t The event was attended by the industry experts: representatives of the Federation Council, State Duma, Ministry of Health of Russia, Eurasian Economic Commission, medical and scientific communities, educational institutions, pharmaceuticals manufacturers, patient organizations.\n</p>\n<p>\n\t On December 10, Maxim Stetsyuk, Executive Director of NANOLEK, delivered a speech as part of the panel discussion \"The role of science in the development of innovative drugs and treatment of genetic and orphan diseases\".\n</p>\n<p>\n\t The organizers brought a variety of experts together to discuss a key topic conсerning modern, effective drugs used for the treatment of rare diseases. The following experts were also invited to participate in the event: Alessandro Cirrinchione (General Director at Novartis Gene Therapies), Vadim Kukava (Executive Director of the Association of the World's Leading Pharmaceutical Companies \"Innovative Pharma\"), Dmitry Kudlay (General Director at Generium), etc. The discussion panel was moderated by Roman Ivanov, rector of the Sirius University of Science and Technology (Autonomous non-profit educational organization of higher education).\n</p>\n<p>\n\t The participants were able to discuss the challenges in science and healthcare covering genetic and orphan diseases, the prospects for the development of Russian science and public healthcare system in the field of early diagnosis, medical care for patients, current scientific Russian and global discoveries in the context of orphan diseases, main trends in changing approaches to the treatment of such diseases in the future, R&D solutions in the field of their treatment.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk, Executive Director of NANOLEK: </b>\"The development strategy of NANOLEK is to produce specialized drugs and vaccines in line with the National Preventive Immunisation Schedule. We decided to set up a domestic production in Russia as part of the Pharma-2020 project to address the issue of availability of such drugs. This particularly applies to idursulfase beta used for the treatment of mucopolysaccharidosis type II (in Russia about 150 patients reportedly suffer from MPS, and annual expenditure on this disease is approx. 3 billion rubles.)\n\t</p>\n\t<p>\n\t\t We have registered this drug and have already gone through some stages of localization, and in 2019 this disease was included in the VZN list and in the regimen for treatment of Hunter syndrome.\n\t</p>\n\t<p>\n\t\t The use of this drug allows to lessen the financial burden on the federal budget since idursulfase beta is 20% cheaper as compared to the current enzyme replacement therapy, i.e. the savings amount to more than 700 million rubles per year.\n\t</p>\n\t<p>\n\t\t The resulting budget savings generated through a cheaper drug therapy allows to increase the number of patients receiving treatment for a specific disease, in this particular case, MPS II, and provide treatment for patients with other nosologies by way of reallocation of funds. Therefore, it is crucial to create a product within the country through cooperation with research centers. We can boast of having successful experience of cooperation with the M.P. Chumakov Center (Federal State Funded Research Institution \"Federal Scientific Center for Research and Development of Immunobiological Drugs of the Russian Academy of Sciences\"), and we also plan to expand cooperation with other research institutions.\"\n\t</p>\n</blockquote>\n<p>\n <b>THE ALL-RUSSIAN PHARMACEUTICAL RALLY (\"Pharmprobeg-2020\")</b> is a professional cross-industry association and an annual automotive press tour, which aims to draw public attention to the most pressing issues of national goals in health care and related industries as well as the development and support of the entire chain: from regulating authorities, manufacturers, distributors and the pharmacy segment to medical communities and patient organizations. Due to the unfavourable epidemiological situation caused by the outbreak of coronavirus infection (COVID-19), in order to prevent its spread in the Russian Federation, \"Pharmprobeg-2020\" moved to a virtual format and became a permanent online expert platform.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/911/Farmprobeg.jpg"},{"tag":"COMPANY NEWS","title":"Vladimir Khristenko, President of NANOLEK hits the list of Russia's top young economic leaders for the second year in a row","date":"14.12.2020","desc":"","link":"/en/news/companynews/vladimir-khristenko-president-of-nanolek-hits-the-list-of-russia-s-top-young-economic-leaders-for-th/","inner_date":"14.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Choiseul 100 Russia ranking was prepared by the team of the independent French think tank \"Institut Choiseul\".\n</p>\n<p>\n\t The main idea behind this international project is to contribute to building better business relations and exchange of experience between successful Russian entrepreneurs, experts and managers of large companies and enterprises and their foreign counterparts included in the Choiseul ranking in France.\n</p>\n<p>\n\t The experts from the Institut Choiseul select the most talented and promising Russian business and economic leaders under the age of forty who have the industry-related potential to contribute to the modernization of the country’s economy and strengthen Russia's position on the world stage. The organizers emphasize that the ranking has neither first nor last places, and is presented in alphabetical order, regardless of gender.\n</p>\n<p>\n\t The main goal of the ranking is to select the talented young economic leaders who have the potential to determine the future horizons of the industry they are engaged in as well as for their country and for the entire world.\n</p>\n<blockquote>\n\t<p>\n <b>Pascal Lorot, President of the Institut Choiseul:</b> \"I’m glad that this time we present the globally unparalleled Choiseul 100 ranking in Russia for the second year in a row despite all the challenges of the pandemic. This is an absolutely independent study, which is formed on the basis of the same principle as Choiseul 100 France. The project's objective is to strengthen bilateral relations between our two great powers by holding various events involving French and Russian award winners, business leaders and public institutions. We have a huge potential for exchange of experience and development in all areas.\"\n\t</p>\n</blockquote>\n<p>\n\t ABOUT THE INSTITUTE\n</p>\n<p>\n\t Based in Paris, the Institut Choiseul is an independent think tank dedicated to the analysis of strategy in global relations and international economic issues. Its ambition is to create an independent dialogue space at the crossroad of the political and public world, economic circles in order to exchange opinions on today’s key problematics. The Institute also offers additional opportunities for meetings and debate between leading decision-makers in politics and economics.\n</p>\n<p>\n\t For many years, the Institut Choiseul has also been a kind of \"talent discoverer\". The Institute publishes rankings of young managers and entrepreneurs under the age of forty who have played or are about to play an important role in the economic development of their countries. 2013 saw the release of the Choiseul 100 France ranking and in 2014, the Choiseul 100 Africa ranking was published. The Choiseul 100 Russia ranking was introduced in Moscow in 2019. The Institut Choiseul is set to contribute to building and fostering of contacts between France and Russia for further development of mutually beneficial cooperation.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bab/Reyting.jpg"},{"tag":"COMPANY NEWS","title":"Experts in Kirov sum up the results of work and prospects for the development of biopharmaceutical and biotechnological industries in the Kirov region","date":"12.12.2020","desc":"","link":"/en/news/companynews/experts-in-kirov-sum-up-the-results-of-work-and-prospects-for-the-development-of-biopharmaceutical-a/","inner_date":"12.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tThe \"My business\" center hosted a round table discussion on the topic \"Work progress and prospects for the development of the biopharmaceutical and biotechnological industries of the Kirov region.\"<br>\n <br>\n The discussion was moderated by Sergey Tolstobrov, Head of the Department for the Development of Economic Territories at NANOLEK, Executive Director of the biopharmaceutical cluster \"Vyatka-Biopolis\".<br>\n <br>\n The following experts delivered their speeches at the event: Mikhail Nekrasov, CEO of NANOLEK, Raif Vasilov, President of Russian Society of Biotechnologists, Sergey Litvinets, Vice-Rector of Vyatka State University. Experts fr om the Ministry of economic development and business support of the Kirov region, representatives of small businesses, leaders of biopharmaceutical and biotechnological clusters delivered their reports as well.<br>\n <br>\n The participants shared the opinion that the authorities, educational and research centers, industrial and business experts should join forces to build a common platform wh ere everyone could exchange their experience and to work out a unified development strategy. For example, the Ministry of economic development and business support of the Kirov region shared the details about efforts to set up the Biopolis special economic zone.<br>\n <br>\n Sergey Litvinets demonstrated the capabilities of Vyatka State University in the field of research that help implement projects of innovative biotechnological companies and achieve better efficiency of project implementation with the assistance of clusters.<br>\n <br>\n At the tail end of the meeting the participants discussed decisions on interaction between the members to be taken to improve the efficiency of companies, talked about the necessary measures of governmental support for participants, the creation of a \"one-stop shop\" to address issues covering product certification and promotion of biotechnological products.<br>\n <br>\n<blockquote>\n <b>Mikhail Nekrasov:</b> \"Historically, the Kirov region is the cradle of biotechnology. As usual, the region performs well in the level of industrial development and excellently trained young professionals. The Biopolis research and education center was established at the premises of our biopharmaceutical complex NANOLEK on the initiative of the Governor of the Kirov region Igor Vasiliev and is about to become a large-scale project both in the region and on a global scale. This will enable us to strengthen and scale up the biotechnological capacities for the production of the latest, state-of-the-art innovative and much-in-demand immunological drugs. We have done a lot together, and there is still a lot of work ahead.\"\n</blockquote>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bb2/Biopolis-MS.jpg"},{"tag":"COMPANY NEWS","title":"Participants of the conference \"Drug supply-360 degrees\" discuss long-term contracts","date":"11.12.2020","desc":"","link":"/en/news/companynews/participants-of-the-conference-drug-supply-360-degrees-discuss-long-term-contracts/","inner_date":"11.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t December 9, 2020 saw a hybrid conference, with attendees both online and offline, which was dedicated to the market for public procurement of medicines.\n</p>\n<p>\n\t The COVID-19 pandemic has significantly affected the pharmaceutical market as well as the public procurement segment. The conference organizers brought together players in the public procurement market: pharmaceuticals manufacturers and experts fr om the regulating authorities openly discussed the ways to ensure timely supplies of modern drugs to general public as well as the outlook for the public procurement system, the future market for orphan drugs, the pros and cons of long-term contracts, innovative models of medicine provision, import substitution, and trends for its regulation in the procurement, lessons learned fr om the COVID-19 pandemic in the public procurement system, etc.\n</p>\n<p>\n\t The event was attended by the specialists from the Ministry of Health, Ministry of Industry and Trade, Federal Antimonopoly Service (FAS), the newly created Federal center for planning of general medical care as well as representatives of professional associations, pharmaceuticals manufacturers, heads of medical institutions, research centres and universities.\n</p>\n<p>\n\t CEO of NANOLEK Maxim Stetsyuk participated in the session \"Long-term contracts - recommendations to government customers, in which cases would that be appropriate?\"\n</p>\n<p>\n\t The order of the President of the Russian Federation (issued in 2014) on development and implementation of long-term contracts covered, among other things, the drug market. This topic has been actively and for a long time discussed in the pharmaceutical community, and there is even a common practice of concluding contracts for 2 and 3 years. In May 2019, the Ministry of Health summed up the results of the first auction for the purchase of vaccines with a delivery period of more than 1 year. The Ministry purchased a pentavalent vaccine for 8.3 billion rubles under a two-year contract with Farmimex. The Russian Ministry of Health also announced its plans to conclude three-year contracts for vaccines: In 2020, the Ministry signed a three-year contract for the delivery of Lenalidomide under the 14 VZN (acronym for Seven Nosologies) program. However, cases wh ere such contracts are concluded are still isolated.\n</p>\n<p>\n\t For example, a 2-year contract under which NANOLEK has delivered vaccines from 2019 proved to be effective: cyclical production, advance planning, no shortage in the regions, execution of the contract amidst the pandemic according to the approved deadlines. Experts of NANOLEK believe that the practice of concluding government contracts for longer periods (3, 5, 7 years) is extremely important.\n</p>\n<p>\n\t Olga Konstantinova, Deputy Head of the Department of Drug Supply and Regulation of Circulation of Medical Devices at the Ministry of Health of the Russian Federation: Nevertheless, there is a \"but\" and this applies to all long-term contracts. This is an issue related to requirements planning. This is probably the most difficult situation we are facing today, wh ere we can't always plan correctly. An expensive drug may not always be in demand. There is a danger that these drugs may be written off due to absence of patients. This is why the experts from the Ministry of Health believe that long-term contracts are a convenient option in general. However, there are still risks that needs could be created in a wrong way, and this could then cause the medicines to be written off.\"\n</p>\n<p>\n\t Olga Konstantinova added that long-term contacts could bring budget savings of 15-25% and cited the example of one of the large contracts on the supply of drugs concluded by the Ministry of Health for a period of three years: \"We managed to agree on a price reduction of 30% when signing a three-year contract. With the reduction of 30% we save 1.7 billion rubles. I don't think it will be a benchmark for all contracts — by 30%. But reduction of 15 to 25% might well be the case.\"\n</p>\n<p>\n <b>Maxim Stetsyuk</b> expressed the opinion that it is extremely important for any manufacturer to understand in advance which vaccines, in particular, and which technologies will be in demand for the Ministry of Health as a customer, after a certain period of time. This is necessary to ensure uninterrupted production and supplies of medicines.\n</p>\n<blockquote>\n\t<p>\n\t\t \"We have been in talks about the issue of long-term contracts with all participants in the process for a long time. There are two basic options here. The first one is mid-term contracts for 2-3 years, and I would say that we have gained positive experience in terms of accurate planning. As far as long-term investment contracts are concerned, it makes sense to talk about 7-year horizon or even longer periods. In this case, the manufacturer realizes in which project he is investing money and resources since investing in pharmaceuticals is one of the most risky and complex tasks. In this case we need to develop subsidiary mechanisms or an offset system. There is a clear view on the market how to build the entire production chain, but it is essential to realize the needs of the customer (Ministry of Health of the Russian Federation). A collaboration with research centers and institutes having the required capacities and laboratory to develop the products progresses quite well and modern manufacturers can scale up the production. There are only a few companies that maintain a full cycle production (from early stages of development to the scaling of complex production facilities). We believe that these areas should be given special attention and it should be developed beyond all doubts.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/030/Lek-obespech.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK's corporate media are winners of the \"Silver Threads 2020\" contest","date":"10.12.2020","desc":"","link":"/en/news/companynews/nanolek-s-corporate-media-are-winners-of-the-silver-threads-2020-contest/","inner_date":"10.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On December 9, the organizers of the Grand National Corporate Media Contest \"Silver Threads 2020\" announced the winners.\n</p>\n<p>\n\t The contest results showed that corporate communications are not just alive in the face of the pandemic restrictions, but, as it turns out, they are taking center stage. A total of 85 projects were submitted for the contest from all over Russia, including Moscow, St. Petersburg, Arkhangelsk, Kirov, Chelyabinsk, Yekaterinburg, Ulyanovsk, Rostov-on-Don, etc.\n</p>\n<p>\n\t It is the first time that NANOLEK not just takes part in the \"Silver Threads\" contest, but also the first time that it has nominated its corporate communications projects before the industry's experts for assessment. The projects submitted had two categories. Even though we are \"newcomers\", our applications landed on the winning podium: the 2nd place in the category \"Best Corporate Social Media Account\" (corporate social media account<a href=\"https://www.facebook.com/nanolek/\"> https://www.facebook.com/nanolek/</a>) and the 3rd place in the category \"Best Corporate Magazine\" (corporate magazine \"NANOLECK INSIGHT\").\n</p>\n<blockquote>\n\t<p>\n <b>Yulia Deyeva, Director for Corporate Communications at NANOLEK,</b>\n\t</p>\n\t<p>\n\t\t \"We should extend our gratitude to the contest organizers for appreciating our input so much. The fact that our projects are on the same podium with major companies such as Gazprom, Sibur, ROSKULTPROEKT, the Bank of Russia, the State Academic Bolshoi Theater of Russia, and others is gratifying.\n\t</p>\n\t<p>\n\t\t No one doubts that being acknowledged by the peers and winning always works as an encouragement and stimulus for new things to do.\n\t</p>\n\t<p>\n\t\t I would like you to know that all the projects winning awards today are done in-house all by ourselves: from ideas to action. Amid the pandemic, we did not slow down. Even more, we reinforced the presence of corporate media through the usual formats of the corporate magazine and social networks both rethought. So, we altered the corporate magazine's look and the focus of posts and articles; actively covering industry news; inviting our employees and partners to join us in communication, and other things. We're glad we set the bar that high right at the beginning. We keep working, we have a lot of plans that we have to put into effect. Even faced with the challenges of today, we go on with creative things.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Anna Shvidunova, member of the jury of the \"Medialeader-2020\" award, Ph.D. in Political Science, PR consultant,</b>\n\t</p>\n\t<p>\n\t\t \"This year's award has shown a good up-level leap in all types of corporate communications. It appears that these external conditions were indeed conducive to galvanize our resources, to make our creative energy explode and the professionalism of PR specialists to step up. It's a big time for communications to prove as relevant and popular as ever. The b2b sector also showed growth. A lot of attention is paid here to building multi-channel communication with audiences, including through new digital channels like messengers and social networks. And it's gratifying for us. The Nanolek case was a clear breakthrough for me in this segment. The guys have just made the b2b communications market to burst. Taking part in the contest for the first time, they immediately became winners in two categories. This is a big win and a great indicator of the efforts our people put into the projects they do. I think that the trend of people's awareness of the role of b2b communications for company image and business success broadly will still grow in today's reality, and professional communications teams in this area will become more and more in demand. In this sense, NANOLEK is a good example and a reference point for \"how to get things done\". We heartily congratulate the team on the award. They deserve it. And we look forward to more projects next year that will be just as exciting and reputation-worthy!'\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Stanislav Naumov, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union,</b>\n\t</p>\n\t<p>\n\t\t \"Dear colleagues, congratulations on your win! I am in sync with the APhMEEU member companies in their decision to take part in various contests, either industry-specific or narrow-focus. This way they can stay in tone, meet their rivals, show what they have achieved, and share their best practices. Especially when we all found ourselves in a situation we had never known before, when in isolation, distant, online... At such a time, it's the corporate media that has proven its usefulness, sustainability rather than a futile budget item. It is even more vital to develop this kind of tool when a team is split geographically into several locations. Indeed, it's an element making the people come together, giving them a team feeling and an opportunity to belong to a common information flow. It's important, it's wanted, and this work has brought you Silver Threads. Keep it up!\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/5f8/Niti.jpg"},{"tag":"COMPANY NEWS","title":"General Director of NANOLEK Takes Part in the XII All-Russian Congress of Pharmaceutical and Medical Industry Workers","date":"08.12.2020","desc":"","link":"/en/news/companynews/general-director-of-nanolek-takes-part-in-the-xii-all-russian-congress-of-pharmaceutical-and-medical/","inner_date":"08.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On December 8, 2020, the XII All-Russian Congress of Pharmaceutical and Medical Industry Workers took place and was part of the business program of the International Scientific and Practical Forum \"Russian Health Care Week.\"\n</p>\n<p>\n\t The Congress was supported by the Russian Ministry of Health, the Russian Ministry of Education and Science, Roszdravnadzor (Russian Federal Health Care Supervisory Agency), and the Russian Academy of Sciences. The event was organized by the Russian Ministry of Industry and Trade, the Russian Union of Industrialists and Entrepreneurs, the Rosmedprom Association, the Russian Federation's Chamber of Commerce and Industry, and more. <b>Yuri Kalinin</b>, President of Rosmedprom Association, moderated the panels. \n</p>\n<p>\n\t The major topics raised during the panel sessions included the counteraction to the spread of a new coronavirus infection; seamless supply of medicines to the healthcare system; the national project \"Healthcare\"; high-profile innovations; the breakthrough drug and medical products launched into production; aspects of cooperation between scientific centers and manufacturers. The panels also summed up the results that industry-specific entities have brought to make Russian drug production more competitive, and many other subjects.\n</p>\n<p>\n\t The Congress was attended by representatives of the Ministry of Healthcare of the Russian Federation, research centers and companies producing medical devices: Minister of Healthcare of the Russian Federation <b>Mikhail Murashko</b>, First Deputy Minister of Industry and Trade of the Russian Federation <b>Sergey Tsy</b><b>b</b>, Director of the Department of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation <b>Alexey Alekhin</b>, President of the Russian Union of Industrialists and Entrepreneurs <b>Alexander Shokhin</b>, President of the Chamber of Commerce and Industry of the Russian Federation <b>Sergey Katyrin</b>, CEO of the Association of Russian Pharmaceutical Manufacturers <b>V</b><b>iktor Dmitriev</b>, and other industry officials.\n</p>\n<p>\n\t Russian Health Minister <b>Mikhail Murashko</b> gave a speech to bring the measures taken by the government to balance the drug price situation in the pandemic to focus. He further highlighted the measures taken for some medicines to be brought to the market quickly. \"The laboratory complexes worked in several shifts so that medicines could be tested and brought to the market soon\", he said. Furthermore, Mikhail Murashko made some comments on the shortage of medicines amid the new incidence rate of COVID-19, \"The medicine consumption is snowballing in autumn. There is an outburst of patients at a time. In this setting, the pharmaceutical industry has given a delay. But now, the volumes have risen and satisfied the current demand. Moreover, among other things, they are currently making some stocks to supply patients with new coronavirus infection adequately.\"\n</p>\n<p>\n <b>Mikhail Nekrasov, General Director of NANOLEK</b>, took part in the Congress as a representative of the production unit. He began his speech for everyone to remember that NANOLEK Biopharmaceutical Enterprise, like all pharmaceutical enterprises, did not cease to operate in times of pandemic. Even more, it went on with producing medicines and even launched new ones on time as dictated by the circumstances.\n</p>\n<blockquote>\n\t<p>\n\t\t \"NANOLEK is a life-supporter, indeed. This is why we could not let the production of vital medicines for the patients e.g. suffering from diabetes mellitus and cardiac dysfunction be halted in the pandemic span; not to mention vaccines and orphan medicines.\n\t</p>\n\t<p>\n\t\t Our company did not stop for even 1 hour in the face of adversity. Seeking to help the Russian people overcome the pandemic, we shifted the annual production program to the ready product of solid dosage forms. We did it as soon as practicable. This product has been available in the COVID-19 treatment guidelines since the early days of the pandemic. It's Hydroxychloroquine. With our technology, we started producing it in Russia very soon.\n\t</p>\n\t<p>\n\t\t Furthermore, Government Resolution No. 441 reducing the expertise scope in amending the documents of the registration dossier for a registered medicinal product contributed as well. The amendments were related to the replacement, adding and excluding the production site of the companies manufacturing the active pharmaceutical substance and the finished dosage form. The primary package is now redesigned as well.\n\t</p>\n\t<p>\n\t\t However, applying Government Resolution No. 441 to the other drug, Favipiravir, which is in great demand, has posed some difficulty. Our company cannot be issued a registration certificate since September 2020 due to various reasons, including the required clinical trial results to be available. From our perspective, we have bioequivalence data and a comparative dissolution kinetics test: these are an adequate basis for the generic product to be registered amid the pandemic. Especially, Government Resolution No. 441 provides for the registration option with post-registration trials.\n\t</p>\n\t<p>\n\t\t Resolution No. 1771 is a very important tool to allow pharmaceuticals to enter the market. It sets forth the pricing scheme that applies to those pharmaceuticals no longer profitable. It enabled us to put Lomustine, an international non-proprietary name for a cancer therapy drug, back on the market\".\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a82/1-MS-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is AmCham awards finalist","date":"07.12.2020","desc":"","link":"/en/news/companynews/nanolek-is-amcham-awards-finalist/","inner_date":"07.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK took part in the award held annually by the American Chamber of Commerce. There are awards in three categories: AmCham Company of the Year, AmCham SME Company of the Year, AmCham Business Person of the Year.\n</p>\n<p>\n\t First, they review the applications. Then they decide on the finalists and winners, one in each category. The award winners are either companies or individuals who have achieved exceptional success in the Russian market, impressive growth, market share, high profile, and a breakthrough in the Russian market, while at the same time proving a long-term commitment to the market and holding to the highest standards of business ethics.\n</p>\n<p>\n\t The award winner is required to prove sustainable performance and commitment to the Russian market and represent the values of entrepreneurship and/or innovation. They must have a proven commitment to corporate social responsibility (CSR) and be an active participant in AmCham.\n</p>\n<blockquote>\n\t<p>\n\t\t \"This year we received a lot of applications, and the fight was very tough. Your company's decision to take part in the contest and tell us about its achievements is a pleasure for us. Moreover, we respect it amid the adversity of the. The rules call for only one winner in each category. But let me, on behalf of the American Chamber of Commerce and the Awards Selection Committee, congratulate NANOLEK on qualifying for the AmCham SME of the Year final,\" <b>said Marcus Montenecourt and Jeff Combs, Co-Chairs of the Awards Selection Committee of the American Chamber of Commerce Board of Directors.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Yulia Deyeva, Director for Corporate Communications at NANOLEK:</b> \"We would like to thank the organizers for the high score they have given to our young company. Even in face of this year's challenges, this was a very rewarding period for NANOLEK. We followed up with our international partners Janssen, Sanofi, Merck, Novartis, and more. There are some strategically important contracts that we have signed. Our product range for export is bigger now. And we go ahead vigorously with vaccination. Participation in such awards is a great chance for the companies to sum up their in-house progress, to have a look at the things achieved, and to make sure we are \"on the same page\" with their peers, not just to announce what they have achieved and made others see their business success. We are very pleased to have a prolific collaboration with the American Chamber of Commerce. We take part in business meetings and think it's a good way for us to keep abreast of new trends, to engage in a dialogue with multiple companies, and to make plans for new projects.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/5f2/AmCham1.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK gets into the final of the \"Best corporate departments\" annual award","date":"04.12.2020","desc":"","link":"/en/news/companynews/nanolek-gets-into-the-final-of-the-best-corporate-departments-annual-award/","inner_date":"04.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The contest has been held for 15 years and is organized by: \"Corporate lawyer\" magazine and Action & MCFR publishing house. The aim of the competition is a public acceptance of professional achievements of corporate lawyers, sharing best practices in legal services and legal risk management, association of professional community of lawyers and raising the general level of significance and status of the legal profession.\n</p>\n<p>\n\t Despite the challenges faced by businesses, 140 applications for award were submitted this year in 12 industry categories. 25 experts evaluated the applicants by voting.\n</p>\n<p>\n\t NANOLEK took part in the \"Chemistry and Pharmaceuticals\" contest nomination, which initially implies competition within the Group with the largest international and Russian corporations from the chemical and pharmaceutical industry.\n</p>\n<blockquote>\n\t<p>\n <b>Head of legal function at NANOLEK - Marina Alexandrovna Mazurevskaya, Deputy CEO for Legal Issues and Government Relations at NANOLEK, member of the Board:</b>\n\t</p>\n\t<p>\n\t\t \"I would like to thank the organizers and experts for high appraisal of our Department's activities. NANOLEK is a young company, it has been operating on the market for only 9 years, but for the second year in a row we have reached the final of the award along with such large corporations as Sibur, Nizhnekamskneftekhim and Pfizer. It is important that our efforts are appreciated by the community of professionals, which motivates us to continue looking for solutions to complex issues and improve our Company’s legal function in line with the best practices.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e79/YUrist.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK provides support to the annual charity \"Lilac ball\"","date":"02.12.2020","desc":"","link":"/en/news/companynews/nanolek-provides-support-to-the-annual-charity-lilac-ball/","inner_date":"02.12.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Interregional Charitable Public Organization \"Hunter syndrome\" traditionally organizes a New Year's (autumn) holiday for children with a rare genetic disease - mucopolysaccharidosis.<br>\n <br>\n\t The charity \"Lilac ball\" is a way to attract public attention to challenges faced by families with children suffering from rare diseases.<br>\n <br>\n\t This exciting holiday is specifically designed to let the guests escape from difficulties just for one evening; a good opportunity for fathers to look at beautiful, well-dressed mothers, for mothers to feel like fairy-tale fays, and children who can imagine themselves being heroes of a magic fairy-tale.<br>\n <br>\n\t The party which was held on board the vessel this year included the following events: a standing buffet, an entertainment show, a charity auction and a fair to showcase items handcrafted by children. The guests observed the dress code rules: evening dresses and formal suits with a lilac or purple ins ert. The mascots and attributes of the ball organizer are the purple bear (the main friend and assistant of MPS patients) and the sun (being a symbol of hope, warmth and kindness).<br>\n <br>\n\t It is no coincidence that NANOLEK became a partner of the event: production of drugs for the treatment of orphan diseases is one of our priority business areas. A short time ago, we reported that we won the \"PRIORITY-2020\" National award, in the \"Localization of production\" nomination, for effective application of advanced technologies. This award was given to us for HUNTERASE, a drug used to treat mucopolysaccharidosis type II\".<br>\n <br>\n\t Today, NANOLEK is the only Russian company that has se t up a local production in Russia to manufacture drugs for the treatment of MPS II. Since January 1, 2019, MPS II has been included in the 14 Cost-Intensive Nosologies List (NL) and is financed from the federal budget. In February 2019, Hunterase<sup>®</sup>\n\twas included in the standards for Hunter syndrome treatment. According to the experts' estimates, administration of Hunterase may save almost 800 million rubles of Federal budget funds over five years as compared to alternative therapy.<br>\n <br>\n\t The ball organizer - The Interregional Charitable Public Organization \"Hunter syndrome\" - has been existing for more than 10 years and unites families with children suffering from a rare genetic disease - mucopolysaccharidosis. It partners with various organizations to develop specifics programs for helping children move forward with their lives and improve the quality of life of families raising children with such severe diagnosis, get involved in scientific research which is required for safe and effective supportive care and treatment.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/3ee/Bal.jpg"},{"tag":"COMPANY NEWS","title":"The Director of the Department of Economic Territory Development at NANOLEK shares his experience in managing innovative projects and research with businessmen of the Kirov region","date":"28.11.2020","desc":"","link":"/en/news/companynews/the-director-of-the-department-of-economic-territory-development-at-nanolek-shares-his-experience-in/","inner_date":"28.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The workshop \"Management of innovative projects, developments, research\" was held on November 26 in Kirov, in the \"My business\" center and was devoted to current issues of organization and development of technological, innovative business and analysis of the main goals to be solved by an innovative entrepreneur.<br>\n <br>\n\t At the workshop, skilled practitioners helped aspiring entrepreneurs understand how to evaluate a technological idea, assess the company's innovative potential, create a project team that is capable to turn the idea into a competitive innovative product, and showed the approach to innovative entrepreneurship and the peculiarities of the innovation ecosystem based on specific examples from international and Russian business practices.<br>\n <br>\n</p>\n<blockquote>\n\t<p>\n <b>Sergey Tolstobrov:</b> \"Today I shared my experience not only as the Director of the Department of Economic Territory Development at NANOLEK biopharmaceutical complex that produces innovative drugs, but also as a representative of the Foundation for Assistance to Small Enterprises in Science and Technology (FASIE) in the Kirov region.\n\t</p>\n\t<p>\n\t\t Participants of the workshop could receive information about available resources and financial support for innovative projects in the region. Besides, we analyzed together typical mistakes when launching an innovative project, discussed how to turn a scientific idea into a profitable project, how to look for a team, partners and investors, and how to attract state support.\n\t</p>\n\t<p>\n\t\t Such events help create as many investment-worthy startups in the region as possible, which, in turn, positively influences the economy of the Kirov region\".\n\t</p>\n</blockquote>\n<p>\n\tThe event was supported by the Ministry of Economic Development of the Russian Federation, the Government of the Kirov region and the Ministry of Economic Development and Support for Entrepreneurship of the Kirov region as part of the National project \"Small and medium-sized businesses and support for individual business initiatives\".\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/348/Njkcnj_hjd.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK holds it strongly: pr is alive in the face of the pandemic","date":"27.11.2020","desc":"","link":"/en/news/companynews/nanolek-holds-it-strongly-pr-is-alive-in-the-face-of-the-pandemic/","inner_date":"27.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On November 25-27, 2020, Moscow hosted the international online conference \"PR PANDEMIC TRENDS-2020\".\n</p>\n<p>\n\t During 3 days, speakers and participants engaged in a vigorous dialogue about the most powerful tools to reach their target audiences and help businesses in the era of the pandemic.\n</p>\n<p>\n\t The country's topmost brands opened up about the real cases through the synergy of Russian and international practices. They presented research, talked about trends. Hot pr debates of experts and delegates, master classes, workshops, and training sessions fr om renowned gurus of the profession unfolded right during the broadcast. That was a hot, instructive, and insightful experience!\n</p>\n<p>\n\t Heads of public relations departments and specialist departments of the major Russian and international companies took part in the event. These spoke on behalf of such major brands as Coca-Cola, HBC Russia, Danon, NANOLEC, GLONASS, Interfax, Rosatom, KFC, Sibur, SAP, POLUS, and others. The list makes it clear that the new reality brings everybody closer to each other, whether B2B, B2C, or even B2G.\n</p>\n<p>\n\t The conference program consisted of three blocks: the first day was devoted to the PR-strategies practice \"in the times of turbidity\". The second day brought together digital experts, who spoke about topical methods of marketing, content transformation, and technologies of interaction with micro- and even nano influencers in the \"coronavirus\" era. On the last day of the conference, the participants talked about the main \"bottleneck\" of all communicators, i.e. how to check whether PR tools work well.\n</p>\n<blockquote>\n\t<p>\n <b>Yulia Deyeva, Director for Corporate Communications of NANOLEK</b>, took part in the first day of the conference as a moderator and speaker. She told her story of trends during the pandemic:\n\t</p>\n\t<p>\n\t\t \"I went to work in a new area for me - pharmaceuticals - on March 13, 2020, on Friday. 2 weeks later we were sent to a blind-end \"remote mode.\" I had to be very swift in adapting to a new reality, not just to a new topic. But that's even of a greater appeal to me. I took the word \"challenge\" as my motto. We revised the PR plan, shifted the focus to social networks, got to care more about our manpower and partners as target audiences. We are still on the active side of our business life: our contributors spoke at 9 online events in October.\n\t</p>\n\t<p>\n\t\t The pandemic amounts to the crisis, after all. Well, PR always talks a lot about anti-crisis communications. Now, it's time for everyone to put the theory into practice. The lockdown proved that the thing that comes to matter most in this adversity is the people's interaction. Indeed, the information field is rich in negative things, so we must try to find positive news and broadcast it. In doing so, we should speak to the point, not just to get \"spotted.\"\n\t</p>\n</blockquote>\n<p>\n\t We would like to thank Inform Media Conferences, the organizer of the \"PR 2020\" conference. This event is a truly high level of content, not just the technical one. You happened to bring together the thought leaders in their fields and share with us the latest applied content without a fluff.\n</p>\n<p>\n\t On our part, we wish to share the most important, in our opinion, trends that the organizers have summarized at the end of the event. Here they are:\n</p>\n<p>\n\t 1. Growth of hybrid professions. The professional competencies are blurring the boundaries between them. An example is an employer's Brand professional (communications/HR/marketing).\n</p>\n<p>\n\t 2. The roles of some professions will rise in value. These professions are wh ere interpersonal skills are required. It's not just about the classic HR, but also about people being enthusiastic about their job functions, or when the psychology of employees is addressed, or for the correct team-working microclimate. At this point, the value of the professions related to the employer's brand management and in-house communications will rise.\n</p>\n<p>\n\t 3. The rising value of soft skills vs hard skills (EQ, communication, self-presentation, networking, critical thinking, uncertainty handling, lifelong learning, bringing people together, and the ability to manage people from a distance).\n</p>\n<p>\n\t 4. The educational ideas like the on-going training, flexible or off-site schedule incentives for staff are the area for the companies to invest in.\n</p>\n<p>\n\t 5. The future leadership will have its essential skills. Just to name a few, being both flexible and able to focus, open to changes, able to shape a vision of the shared future and a critical mindset.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/0d2/YUliya-moderator.jpg"},{"tag":"COMPANY NEWS","title":"The General Director of NANOLEK takes part in the round table discussion \"Current approaches to solving reproductive health problems\"","date":"27.11.2020","desc":"","link":"/en/news/companynews/the-general-director-of-nanolek-takes-part-in-the-round-table-discussion-current-approaches-to-solvi/","inner_date":"27.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The event was held as part of the All-Russian Congress of patients.\n</p>\n<p>\n\t The discussion was devoted to the issues related to the decline in birth rates. Reproductive health moves to the forefront when we are taking appropriate measures to ensure the growth of the Russian population and demographic stability.\n</p>\n<p>\n\t Speakers of the round table discussion dwelled on the demographic situation, measures of support taken at the government level to help quickly and consistently eliminate bottlenecks, on things that hinder the improvement of the people's reproductive health.\n</p>\n<p>\n\t The following experts were invited to participate in the event: Natalia Sergeevna Solovyova (Chairman of the Association of Individuals Suffering from Infertility), Igor Yurievich Kogan (Director of the D. O. Ott Scientific and Research Institute of Obstetrics, Gynecology and Reproductology, corresponding member of RAS (Russian Academy of Sciences), professor at the Department of obstetrics, gynecology and reproductive science of the St. Petersburg State University, MD), Tatiana Viktorovna Buckaya (expert at ONF (All-Russia People’s Front), Chairman of the Board of Mothers of Russia, President of the Association of Consumers and Producers of Children's Goods and Services \"Choice of Parents\"), Mikhail Sergeevich Nekrasov (General Director, Chairman of the Board of NANOLEK LLC) and other experts.\n</p>\n<p>\n\t The discussion was moderated by: Oleg Ivanovich Apolikhin (Chief freelance expert on reproductive health of the Ministry of Health of the Russian Federation, Director of the N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology, a branch of the FSBI \"SMRC of radiology\" of the Ministry of Health of Russia, MD, professor, corresponding member of the Russian Academy of Sciences), Kirill Viktorovich Litovchenko (Head of the Think Tank on Demographic Policy and Reproductive Health of the All-Russian Public Organization \"Delovaya Rossiya\", General Director of Ferring Pharmaceuticals LLC).\n</p>\n<p>\n\t Mikhail Nekrasov mentioned in his report that cervical cancer is the only oncological disease that can be prevented by way of primary prevention - an HPV vaccine, according to the World Health Organization. 91 countries have included this vaccine in their national vaccination schedules.\n</p>\n<p>\n\t Cervical cancer (CC) was found to be caused by HPV 16 and 18 in 66.2% of cases, according to independent scientific publications. In Russia, the incidence of cervical cancer has increased by 25.81% since 2007. As the patients are young women, this certainly results in the socio-demographic damages and loss of reproductive capacity.\n</p>\n<blockquote>\n\t<p>\n\t\t \"This topic is also very important for achieving the targets as part of the \"Healthcare\" national project which focuses on increasing the life expectancy of citizens. Cancer is the second leading cause of death globally, according to the statistics, so we need to fight this challenge.\n\t</p>\n\t<p>\n\t\t NANOLEK joined forces with Kombiotech to develop an entirely domestic 4-valent vaccine against HPV (human papillomavirus) of 4 types (6, 11, 16, 18), which causes cervical cancer. Mikhail Sergeyevich explained that research on this vaccine will be launched in the near future, registration will follow in 2023.\"\n\t</p>\n</blockquote>\n<p>\n\t The All-Russian Congress of Patients is held annually by the All-Russian Union of Patients which is supported by the Ministry of Health of the Russian Federation, the Federal Service for Supervision of Healthcare, and federal authorities.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a9e/MS-2.jpg"},{"tag":"COMPANY NEWS","title":"President of Nanolek takes part in a business breakfast organized by AmCham Russia","date":"27.11.2020","desc":"","link":"/en/news/companynews/president-of-nanolek-takes-part-in-a-business-breakfast-organized-by-amcham-russia/","inner_date":"27.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The American Chamber of Commerce (AmCham Russia) is one of the leading foreign business associations in Russia, which unites more than 500 major American, European and Russian companies.<br>\n <br>\n\t On November 26, 2020, Vladimir Khristenko took part in a business breakfast organized by Alexis Rodzianko, President of the American Chamber of Commerce in Russia, and Ekaterina Pogodina, CEO of Johnson & Johnson LLC.<br>\n <br>\n\t The meeting was attended by the heads of various companies, and members of the American Chamber of Commerce. They discussed the consequences of the pandemic for various fields of business activities, shared their experience in overcoming the challenges faced during lockdown and business transformation. Besides, they dwelled on new trends and possibility of whether they will remain in the future.<br>\n</p>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b> “Despite the fact that the popular saying, the world will never be the same, wears off a bit, it reflects supremely well what is happening nowadays. We have survived the first wave of the pandemic and learned to live in a new reality, therefore I believe, everything is more quiet now and, most importantly, people's approach to the pandemic became more constructive.\n\t</p>\n\t<p>\n\t\t Pharmaceutics is an industry where no one can relax in whatever the circumstances may be. We bear the responsibility for people's health. We are fostering all our efforts and staying on the front line. It is important that we have the opportunity to hold such meetings, exchange opinions, and design new trends. It should be noted that all companies, regardless of the type of activities, are heading towards digitalization of businesses, optimization of business processes, and partially revising their strategies. Such communication is conductive to the implementation of joint initiatives with representatives of the leading global corporations.\"\n\t</p>\n</blockquote>\n<p>\n <br>\n\t We would like to remind that in 2019 NANOLEK and Janssen, a pharmaceutical division of Johnson & Johnson LLC, released a statement that the production of a drug used in the treatment of multiple myeloma was localized in Russia.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/2f2/VV.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK wins the \"PRIORITY-2020\" award for effective use of advanced technologies","date":"25.11.2020","desc":"","link":"/en/news/companynews/nanolek-wins-the-priority-2020-award-for-effective-use-of-advanced-technologies/","inner_date":"25.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On November 24, the Great hall of the Civic Chamber of the Russian Federation hosted the ceremony to award the winners of the 6th National Award \"PRIORITY-2020\" in the field of effective use of advanced technologies.\n</p>\n<p>\n\t For the second year in a row, NANOLEK has won this prestigious award, this year in the nomination \"Localization of production\" for HUNTERASE® - the drug used in the treatment of Hunter syndrome.\"\n</p>\n<p>\n\t The award is given for achievements in the development, implementation and promotion of advanced domestic technologies in all industries and IT areas. The year 2020 saw more than 30 nominations, and more than 70 companies from different industries that became nominees: IT, medical science, telecommunications, construction, pharmaceuticals, transport, logistics, etc. The contest is powered by the industry-related ministries and departments of Russia – the Ministry of Industry and Trade, the Ministry of Agriculture, Ministry of Energy, Ministry of Communications as well as public associations: Russian Union of Industrialists and Entrepreneurs, Russian Сhamber of Commerce and Industry, \"Delovaya Rossiya\", Federal Customs Service and Federal Antimonopoly Service.\n</p>\n<blockquote>\n\t<p>\n\t\t “The \"Priority Award\" is a socially significant event, it drives the development of production of domestic high-tech products and helps enhance competitiveness of our industry in the domestic and foreign markets,“ said <b>Yuri Borisov, Deputy Prime Minister of the Russian Federation.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t “The \"Priority 2.0\" national award is a landmark event for the real economy, for companies that do not rest today on their laurels amidst challenging economic conditions, develop production facilities and technology and achieve competitive advantages in the domestic and global markets,“ said <b>Vitaly Rasnitsyn, Chairman of the Award Organizing Committee.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Elena Stukun, Deputy General Director for Sales at Nanolek</b>, took the occasion during the award ceremony to thank the organizers and the expert council for evaluating highly the Company's efforts:\n\t</p>\n\t<p>\n\t\t \"NANOLEK specializes in the production of import-substituting and innovative drugs for the prevention and treatment of socially significant diseases. Today we received an award for the original drug Hunterase® used to treat the orphan disease mucopolysaccharidosis type II. To date, we have completed the first stage of production localization in the Russian Federation.\n\t</p>\n\t<p>\n\t\t An amazing work done by our team is an evidence that we are able to produce innovative drugs meeting all international standards in our country. Dear colleagues, I would like to express my gratitude towards our team for their achievements. We in turn will continue to do our best for the development of the Russian pharmaceutical industry and draw attention to the issues of orphan diseases.\"\n\t</p>\n</blockquote>\n<p>\n\t About MPS II\n</p>\n<p>\n\t Mucopolysaccharidosis type II (MPS II) is a severe, disabling disease. Since January 1, 2019, MPS II has been on the list of 14 high-cost nosologies (VZN). In February 2019, Hunterase® was included in the standard regimen to treat Hunter syndrome. NANOLEK is currently the only Russian company that maintains a domestic facility in Russia to produce a drug used for the treatment of the disease. The NANOLEK facility that produces Hunterase® is located on the biopharmaceutical complex in the Kirov region. This guarantees that medicines are supplied uninterrupted to patients in Russia suffering from this rare disease. Domestic production also allows to lessen the financial burden on the federal budget since Hunterase® is more than 20% cheaper as compared to the alternative enzyme replacement therapy.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/877/PRioritet.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk, Executive Director of NANOLEK Speaks at the Russian Pharmaceutical Forum","date":"24.11.2020","desc":"","link":"/en/news/companynews/maxim-stetsyuk-executive-director-of-nanolek-speaks-at-the-russian-pharmaceutical-forum/","inner_date":"24.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Adam Smith Conferences holds the annual Pharmaceutical Forum which has proved itself as a major industry event for executives of international and Russian manufacturing companies, distributors and retailers, representatives of various departments, and experts of the pharmaceutical market.\n</p>\n<p>\n\t The Forum was started with the discussion \"From 2020 to 2030: Modernization of Healthcare and Medicine Supply Systems in Russia\". The panelists and very active contributors were: Maxim Stetsyuk, Executive Director of NANOLEK; Matthias Wernicke, General Manager of Merck, Russia and the CIS; Peter Rodionov, General Manager of GEROPHARM; Vasily Ignatyev, General Manager of R-Pharm; and Marek Vasicek, General Manager of Bristol-Myers Squibb. The session was moderated by Elena Kartasheva, President of Takeda.\n</p>\n<p>\n\t All the participants have agreed that the Russian pharmaceutical industry has proved to be able to cope with new challenges during the crisis; and a global spread of new coronavirus infection has revealed the willingness of Russian and global companies to deliver quick results and give a prompt response in the event of force majeure. But the extreme working conditions in which economies and health care systems of all countries without exception found themselves, highlighted some \"bottlenecks\" as well. This year marks the period of summing up the ten-year \"Pharma-2020\", and the current circumstances coincide with the completion of the program and a smooth transition to the \"Pharma-2030\".\n</p>\n<p>\n\t The participants pointed out that 10 years ago when the Pharma-2020 program was announced many things seemed to be really hard to do. Yet after these years, it was clear that the pharmaceutical market became attractive both for the Russian and foreign investments.\n</p>\n<p>\n\t Each speaker made an evaluation of the Pharma-2020 program: they dwelled on results that had been achieved over the past ten years, lessons which can be learned from the implementation of the Pharma-2020 strategy, the ways to secure higher competitiveness of the Russian pharmaceutical industry. Moreover, the participants to the Forum have touched upon the state initiatives to support medicine developers and manufacturers; development of the API market in order to achieve drug and national security; strategies and development prospects for the immunoprophylaxis of infectious diseases; the ways to launch Russian products on foreign markets and the latest investment areas for the Russian pharmaceutical industry.\n</p>\n<p>\n\t The panelists have emphasized that a lot has been done over the past decade: aggressive development of localization, transfer of the latest technologies to Russia, and integration between Russian and Western manufacturers. A lot of efforts has been made to revise the regulatory framework, legislation and pricing. Besides, new items have been added to the lists of cost-intensive drug and VED (Vital and Essential Drugs) lists; the new innovative drugs have been developed; GMP sector and clinical trials have experienced dynamic growth, and much more.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk:</b> \"The key customer in Russia is the government itself. In the \"Health Care\" program you need to realize well in advance wh ere you are going next, which specific programs need to be developed; and vaccination is one of the key projects. Indeed, it would be more correct to prevent diseases, especially when it comes to dangerous diseases. While we were battling coronavirus, we gathered unique experience that helped us understand why it is so vital to have this preventive mechanism in place. We need to develop our vaccination schedule jointly with the government, but this job isn't easy. E.g. we have localized the production of a 5-component vaccine over the past 5 years. This vaccine protects against 5 dangerous infections with one shot only and this is a new opportunity we have never had before.\n\t</p>\n\t<p>\n\t\t Some other important projects we have created are, first of all, localization of the poliomyelitis vaccine production; the world still has up to a 50% deficit of this vaccine. Russia is one of the few countries that can bridge this gap.\n\t</p>\n\t<p>\n\t\t Secondly, we have launched a public-private partnership with the M.P. Chumakov Scientific Center to set a very positive example to others. We anticipate registration to be completed in Q1 2021 and by this time we hope Russia will have a full-cycle domestic facility to produce polio vaccines.\n\t</p>\n\t<p>\n\t\t All of these steps forward should be taken jointly with institutions, colleges and universities in order to develop both manufacturing and R&D competencies. This is the next step to be taken as part of Pharma-2030 objectives. Implementation of such projects requires a long-term planning program since a 3-5 year production planning is not sufficient in terms of investment horizon, especially when it comes to vaccines. Lead time on investment in any advanced technology is 7-10 years or more. All of us will need to join force with the government to develop such long-term programs.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/eb1/Maksim-farm-forum-24.11.jpg"},{"tag":"COMPANY NEWS","title":"On November 19, the \"My business\" Сenter hosted a round table discussion to dwell on issues relating to interaction between businesses and support infrastructure in the biotechnological sector","date":"19.11.2020","desc":"","link":"/en/news/companynews/on-november-19-the-my-business-senter-hosted-a-round-table-discussion-to-dwell-on-issues-relating-to/","inner_date":"19.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Heads of the Ministry of economic development and business support of the Kirov region, representatives of the Kirov regional Fund for support of small and medium-sized businesses, representatives of the Fund for assistance to innovations in the Kirov region and the Komi Republic, the public representative of the Agency for strategic initiatives in the Kirov region spoke at the event \"Opportunities for interaction between small and medium-sized businesses and regional infrastructure for support and development in biotechnology\".\n</p>\n<p>\n\t The discussion was moderated by Sergey Tolstobrov, Head of the Department for the Development of Economic Territories at NANOLEK, representative of the Fund for Assistance to the Development of Small Enterprises in Science and Technology (Fund for Assistance to Innovations) in the Kirov region.\n</p>\n<p>\n\t The participants of the round table talked about the government and regional support provided for companies and organizations engaged in biotechnology, the experience gathered by neighbouring regions, and best practices of cooperation.\n</p>\n<blockquote>\n\t<p>\n <b>Sergey Tolstobrov: </b>\"Such events are important and necessary for all parties involved since we have the opportunity to discuss the issues of real support, review the positive and negative experience in obtaining government support by sitting at the same table. Today, we and the participants of the round table have agreed that the clusters will submit their proposals in order to improve the procedures and areas of support.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/b57/Tolstobrov-19.11.jpg"},{"tag":"COMPANY NEWS","title":"Experts of NANOLEK took part in the round table discussion \"Early diagnosis and multidisciplinary approach are the key to high quality of life for patients with mucopolysaccharidosis\"","date":"16.11.2020","desc":"","link":"/en/news/companynews/experts-of-nanolek-took-part-in-the-round-table-discussion-early-diagnosis-and-multidisciplinary-app/","inner_date":"16.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tIn late October, representatives of NANOLEK - Maxim Kurbatov, Head of the Department of Market Launch of Medicines, and Vadim Kalinichenko, Head of the Medical Department, took part in the round table discussion \"Early diagnosis and multidisciplinary approach are the key to high quality of life for patients with mucopolysaccharidosis (MPS II)\".<br>\n <br>\n The discussion held in Almaty (Kazakhstan) was organized by the Scientific center of pediatrics and pediatric surgery under the Ministry of health of the Republic of Kazakhstan.<br>\n <br>\n The main objective of the event was to share experience in the area of orphan pathology (MPS II), experience on enzyme replacement therapy with physicians and patient organizations as well as to provide assistance to patients and their parents. Special attention was paid to analyzing the characteristics of Hunterase<sup>®</sup> (previously, a market authorization was issued by the Ministry of health of the Republic of Kazakhstan).<br>\n <br>\n Vadim Kalinichenko spoke about the importance of early diagnosis and a multidisciplinary approach in the diagnosis of MPS II, and Maxim Kurbatov covered the issues of social adaptation and rehabilitation support for patients with MPS II.<br>\n <br>\n NANOLEK positions itself as a socially responsible company that has drugs in its portfolio to treat orphan diseases, in particular MPS II. This is a severe disabling disease that manifests itself in early childhood and leads to death without proper treatment. Therefore, it is crucial to recognize the symptoms of the disease as early as possible. The only possible method of pathogenetic therapy for patients with MPS II today is enzyme replacement therapy.<br>\n <br>\n Vadim Kalinichenko answered in detail the questions asked by physicians present at the meeting concerning the effectiveness and safety of idursulfase beta, its advantages as compared to the therapy used. Maxim Kurbatov went into details concerning the experience of providing assistance from the time of diagnosis to prescribing treatment with enzyme replacement drug Hunterase<sup>®</sup>. <br>\n <br>\nThe discussion also included exchange of contacts between laboratories of\nRepublican centers in order to establish working relations, talks about the\nways of assistance by NANOLEK at the stages of MPS II screening and diagnosis\nin the Republic of Kazakhstan, and talks about possible ways of involvement of\nphysicians of Republican centers dealing with treatment of patients with orphan\npathologies in clinical trials.\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/227/x-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK's Director of the Department for Development of Economic Territories – A Participant of the Round Table Talk: Certification of Products by Biotechnological Enterprises","date":"11.11.2020","desc":"","link":"/en/news/companynews/nanolek-s-director-of-the-department-for-development-of-economic-territories-a-participant-of-the-ro/","inner_date":"11.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Sergey Tolstobrov, Director of the Department for Development of Economic Territories at NANOLEK, took part in the round table talk called Certification of Products by Biotechnological Enterprises.\n</p>\n<p>\n\t The event was held at the My Business centre on November 11, supported by the Ministry of Economic Development of Russia, the Government of the Kirov Region, and the Ministry of Economic Development and Support of Entrepreneurship of the Kirov Region within the framework of the national project – Small and Medium Business and Support for Individual Entrepreneurial Initiatives.\n</p>\n<p>\n\t This meeting is held for the Vyatka-Biopolis Biopharmaceutical Cluster participants and other biotechnological clusters of the Kirov Region.\n</p>\n<p>\n\t The following problems were discussed at the round table: difficulties and obstacles faced by biotechnology and biopharmaceutical companies when passing certification and declaration procedures; the necessity for a certification advisory centre in the region; the possibility of supporting certification procedures by the My Business centre of enterprises of the Biopharmaceutical cluster of the Kirov Region.\n</p>\n<blockquote>\n\t<p>\n <b>Sergey Tolstobrov:</b> “Today, the problem of the shortage of a reliable advisory centre for product certification in the region has been vividly expressed, and within the framework of the development of the infrastructure of the Biopolis project, it can find a solution, contributing to the development of biotechnological small businesses in the Kirov Region”.\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/07b/Tolstobrov-11.11.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK presents medical devices for extracorporeal blood detoxification at the forum \"Issues of Urgent Cardiology-2020\"","date":"11.11.2020","desc":"","link":"/en/news/companynews/nanolek-presents-medical-devices-for-extracorporeal-blood-detoxification-at-the-forum-issues-of-urge/","inner_date":"11.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On November 11, the XIII All-Russian Forum \"Issues of Emergency Cardiology - 2020\" was launched, which is supported by the Ministry of Health of the Russian Federation and the RPO \"Society of Specialists in Emergency Cardiology\".\n</p>\n<p>\n\t The Forum is being held for the thirteenth time, this year, due to the epidemiological situation, the Forum events are held online. The Forum agenda has a scientific and practical focus in the field of emergency cardiology and covers all aspects of the organization and implementation of patient care.\n</p>\n<p>\n\t It is difficult to overestimate the relevance and theme of the Forum, especially considering the important tasks set for the national medicine within the framework of the National Project \"Healthcare\". First of all - to increase the life expectancy of citizens of our country. The program of the forum includes lectures, scientific and practical seminars, analyzes of clinical cases, within the framework of which the latest achievements in the field of urgent cardiology will be presented.\n</p>\n<p>\n\t As part of the material and technical aspects of urgent cardiac care and the introduction of innovative technologies, NANOLEK will present <b>Efferon columns for hemosorption</b>. Extracorporeal blood detoxification has a positive effect on a number of fundamental factors that determine the severity of the course and prognosis in patients with severe angina pectoris and acute myocardial infarction. Methods of extracorporeal detoxification of blood can significantly reduce the severity of the syndrome of endogenous intoxication, remove toxins of average molecular weight, which has a beneficial effect on the clinical progression of the disease and objective indicators of the state of the cardiovascular system.\n</p>\n<p>\n\t The Forum is open for public, registration for online participation on the website:<a href=\"https://www.em-cardio.ru/\">https://www.em-cardio.ru/</a>\n</p>\n<p>\n <b><i>Company and product information</i></b>\n</p>\n<p>\n\t NANOLEK is a modern fast-evolving Russian biopharmaceutical company with its own high-tech complete cycle production compliant with GMP and ISO standards. NANOLEK specialises in the production of import-substituting and innovative pharmaceuticals, both in-house developed and invented with the help of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique experience in the area of transfer of technologies as part of partnership with the leading international pharmaceutical companies (Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.)\n</p>\n<p>\n\t LLC Nanolek took the first place in the category \"Fast-growing large companies\" of the rating \"TECHUSPEH\"-2019, and the company was also a member of the priority project of the Ministry of Economic Development of Russia \"Support of Leading Private High-Tech Companies\" (\"National Champions\") in 2017.\n</p>\n<p>\n\t In April 2020, Nanolek announced the start of a strategic partnership with Efferon JSC to actively launch special medical products for the treatment of \"cytokine storms\", sepsis and septic shock.\n</p>\n<p>\n\t Efferon JSC was founded by graduates of the Faculty of Chemistry of Moscow State University named after M.V. Lomonosov and the INEOS RAS named after A.N. Nesmeyanov in 2017. The company is a resident of the Science Park of Moscow State University and the Skolkovo Foundation Biomedical Cluster. It has developed and is now producing two new medical devices - Efferon CT absorption columns for the treatment of cytokine storm syndrome and acute respiratory distress syndrome (ARDS), and Efferon LPS for the treatment of sepsis and septic shock. Both medical devices received market authorization granted by Roszdravnadzor and are approved for use in clinical practice. The columns have already been successfully tested on the basis of the Lomonosov Moscow State University Medical Scientific and Educational Center, City Clinical Hospital No. 67 named after L. A. Vorokhobov, City Clinical Hospital No. 1 named after N.I. Pirogov, Infectious Disease Clinic No. 2, National Medical Research Center of Oncology (Rostov-on-Don) and many other advanced medical institutions.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a0d/kardio.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk, Executive Director of NANOLEK, participant of the forum \"COVID-19: vaccination and immunization\"","date":"02.11.2020","desc":"","link":"/en/news/companynews/maxim-stetsyuk-executive-director-of-nanolek-participant-of-the-forum-covid-19-vaccination-and-immun/","inner_date":"02.11.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<div>\n\tOn October 29, 2020, the radio station Komsomolskaya Pravda hosted the weekly program \"Business Friday\".\n</div>\n<p>\n\t The participants of the meeting discussed the main topics devoted to the \"race to approve a Covid vaccine: which are the achievements in vaccine development in Russia and worldwide, new research, challenges; the pros and cons of vaccination on the whole; domestically produced or imported vaccines - the truth and myths about the quality of domestic and foreign vaccines.\n</p>\n<p>\n\t The representatives of the expert community joined the conversation:\n</p>\n<p>\n\t - <b>Tatyana Kusayko</b>, member of the Federation Council of the Federal Assembly of the Russian Federation, Deputy Chairman of the Federation Council Committee on Social Policy, senator of the Russian Federation;\n</p>\n<p>\n\t - <b>Maxim Stetsyuk</b>, Executive Director of NANOLEK;\n</p>\n<p>\n\t - <b>Andrey Lomakin</b>, first Deputy General Director of FORT biopharmaceutical plant\n</p>\n<p>\n\t - <b>Nikita Lomakin</b>, chief cardiologist, chief researcher at the Central clinical hospital of the President's administration.\n</p>\n<p>\n <b>Tatyana Kusayko</b> highlighted the distinctive features of influenza and other viral diseases which help differentiate them from coronavirus, e.g. the incubation period for influenza usually lasts 3 days, for COVID-19 – 5-6 days. The speaker reminded that people need to follow the recommendations issued by Rospotrebnadzor (The Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing) to prevent the risk of infection. And although you may come across the symptoms of COVID-19 on websites of different health authorities, the experts recommended that people consult a doctor as the first symptoms appear.\n</p>\n<p>\n <b>Andrey Lomakin</b> urged listeners to get flu vaccines as this is, to his mind, especially important amidst the coronavirus pandemic. This year, more than 75 million doses of domestic influenza vaccine are expected to be delivered to the market. The distinctive feature here is that trivalent and quadrivalent vaccines protect against three different virus strains, according to recommendations by WHO.\n</p>\n<p>\n <b>Nikita Lomakin</b> spoke about the clinical trials of the Covid-19 vaccine with volunteers aged 60+ years at increased risk, which are conducted by the Central clinical hospital. People in this age group are at risk of developing severe and very severe disease forms.\n</p>\n<p>\n\t Vaccination is the most effective way to get protected from many viruses and infections, <b>Maxim Stetsyu</b><b>k</b> assured that in the case of any doubts (e.g. whether or not to be vaccinated), we should draw on expertise and experience of international credible organizations. For example, findings by WHO and UNICEF experts show that vaccination fully meets the expectations. There are also economic indices that prove the necessity of vaccination. For every ruble invested in vaccination, there is a ten- to fifteenfold return.\n</p>\n<p>\n <b>Maxim Stetsyuk </b>emphasized the following:\n</p>\n<p>\n\t \"Russia maintains an efficient vaccination schedule that protects against 12 vaccine-controlled diseases, and is considered to be one of the best worldwide. That was the way how we managed to reduce three times the infant mortality rate in the first years of life. Therefore, building of awareness among parents is very important.\n</p>\n<p>\n\t And, of course, it is also important to cooperate with domestic vaccine manufacturers. In particular, NANOLEK is making tremendous efforts to improve vaccination. Currently, you can protect your child from 5 infections at once with one injection only, which helps ease the economic burden on the budget and burden on clinics.\n</p>\n<p>\n\t Over the past 10 years, Russia has made considerable progress in this area, and domestic vaccines are not at all inferior, and in some cases even superior to imported ones. As far as quality of domestic vaccines is concerned, I hasten to strip away a long held assumption that \"imported drugs are always better than those made in Russia\". Responsible-minded biopharmaceutical producers comply in their work with global GMP standards. This is a system of requirements for compliance with the highest quality at every production stage, full compliant with the best quality management practices. I will give some facts that will dispel any skepticism: 30% of our staff are employees dealing with quality management issues by performing a huge number of tests, analyses, and samples. And no production is made without their prior approval, not a single operation is processed without their permission, without a 100% confidence that all the guidelines and requirements of the international standards are complied with.\n</p>\n<p>\n\t As for today's topic of conversation, I would like to note that an ideal vaccine formula is as follows: excellent safety, high efficiency, and high availability which means that it must be produced in sufficient quantities. Everyone of us of us wishes that all the components are achieved. We, at NANOLEK, are absolutely prepared for this and actively cooperate with research centers and institutions to develop modern domestic vaccines and to protect people from vaccine-controlled diseases.\"\n</p>\n<p>\n <b>About NANOLEK</b>\n</p>\n<p>\n\t NANOLEK is a modern fast-evolving Russian biopharmaceutical company with its own high-tech complete cycle production compliant with GMP and ISO standards. NANOLEK specialises in the production of import-substituting and innovative pharmaceuticals, both in-house developed and invented with the help of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique experience in the area of transfer of technologies as part of partnership with the leading international pharmaceutical companies (Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.)\n</p>\n<div>\n\tNanolek LLC won the \"Platinum ounce-2019\" contest in the \"Vector of the year\" nomination, \"Project of the year. Business project\" subnomination, took the first place in the \"Fast-growing large companies\" category of the \"TECHUSPECH\" 2019 ranking, besides the company participated in the priority project of the Ministry of economic development of Russia \"Support for private high-tech leading companies\" (\"National champions\") in 2017.\n</div>\n<p>\n\t The company is now one of the Russia’s leading producers of paediatric vaccines. NANOLEK’s diversified drug portfolio covers the following therapeutic areas: vaccines, drugs for treatment of HIV, oncological diseases, etc. \n</p>\n<p>\n\t On August 14, 2019, Nanolek LLC was taken off the list of RUSNANO portfolio companies.\n</p>\n<p>\n\t In 2020, Nanolek LLC was included in the list of systemic companies in Russia.\n</p>\n<p>\n\t The decision to add the company to the list was made by the Government commission for improving the sustainability of the Russian economy. The business reference list is published on April 25, 2020 on the website of the Ministry of Industry and Trade of Russia.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/096/Radio.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK's General Director Takes Part in the INNOPROM Session: Innovations in Pharmaceuticals and Medicine: Overcoming Barriers in the Development and Creation of Solutions","date":"27.10.2020","desc":"","link":"/en/news/companynews/nanolek-s-general-director-takes-part-in-the-innoprom-session-innovations-in-pharmaceuticals-and-med/","inner_date":"27.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The participants discussed the critical issues of changes that are taking place in the coronavirus reality: challenges for manufacturers in the development of innovative products and relevant government support measures for them, the impact of the pandemic on attitudes to innovation on the part of business and regulators, as well as how the interaction of fundamental science and production is going to develop.\n</p>\n<p>\n\t The meeting was moderated by Vadim Tarasov (I.M.Sechenov First Moscow State Medical University). Among the participants in the session were: Dmitry Galkin (Deputy Director of the Development Department of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia), Dmitry Akhaev (Deputy Dean of the Faculty of Biology for Innovation at M.V.Lomonosov Moscow State University), Mikhail Nekrasov (NANOLEK's General Director), Dmitry Kudlai (General Director of Generium, JSC), Andrey Ivashchenko (Chairman of the Board of Directors of NP TsVT KhimRar) and others.\n</p>\n<p>\n\t The pandemic has highlighted some weaknesses in health systems worldwide. Due to this fact, we are continually analysing and making conclusions to take practical steps to improve communication among key stakeholders in the health industry. Simultaneously, the ongoing changes have sharpened and revealed one of the most important pharmaceutical and medical sectors' objectives - creating innovative products.\n</p>\n<p>\n <b>Vadim Tarasov, Director of the Institute of Pharmacy and Translational Medicine of the Sechenov First MSMU:</b> \"The pandemic has shown that Russia, like other leading countries of the world, can generate its innovative products thanks to its research school. In the shortest possible time, our companies, the industry leaders, have brilliantly made a whole range of Russian medicines that allow our state and citizens to feel protected and receive adequate high-quality preventive treatment. This applies to the developments that have been made, among other things, by the participants in our discussion today. This also applies to vaccines in the field of which our country is at the forefront.\n</p>\n<p>\n\t Now we are faced with the central question of creating a unified system in the Russian Federation that would make it possible to build truly innovative products. Moreover, there are already practical steps in this direction. Several large-scale projects for the development of science are being launched in the country, and a strategic academic leadership program is being launched. It is based on the cooperation of research institutions, scientific centres of Russian universities, which, in close connection with industrial, pharmaceutical enterprises, must build a chain for developing and implementing innovative products in the pharmaceutical and medical industries.\"\n</p>\n<p>\n\t Currently, we are all going through a severe ordeal. We are witnessing how the world's leading countries could create reasonably quickly innovative medications that are needed for the treatment and prevention of Covid-19, including vaccines. Finding and producing vaccines is difficult and expensive, although essential for national security and export potential.\n</p>\n<p>\n\t NANOLEK is one of the leaders in the production of paediatric vaccines. The participants were interested in hearing a comment on how the company sees development opportunities in terms of increasing its stability, what questions are there for the government and regulators about setting up the production of domestic vaccines, introducing the most promising developments, and what steps must be taken to perform the transition to innovation.\n</p>\n<p>\n <b>Mikhail Nekrasov, NANOLEK's General Director:</b> \"NANOLEK is an innovative company in the first place. We initially decided that we are an enterprise that is engaged in production as well as scientific research. Our company's development strategy is to combine scientific competencies and production resources for the implementation of joint projects to develop innovative immunobiological medicines; cooperation with leading scientific institutions. I mean collaborative work with the M.P.Chumakov Scientific Centre, and with Skolkovo. This approach helps develop science and ultimately not only creates but also produces original medicines.\n</p>\n<p>\n\t Finding vaccines is not an easy job, but we understand that a biotech enterprise has two parts: sterile filling and the finished form production. The second is the production of the antigens themselves.\n</p>\n<p>\n\t Thanks to the Ministry of Industry and Trade - its Pharma 2020 program has given impetus to develop innovative products in the industry. Now we discuss with them and the Ministry of Health the need to create additional experimental-industrial capacities that will make it possible to bring scientific developments into industrial production.\n</p>\n<p>\n\t In this case, we are following the path of agreements with leading institutions. From laboratory development to production - it is a big step. We started by making the first step - a pure form (vaccine production: Polimilex®, an inactivated poliomyelitis vaccine, and Pentaxim®, a vaccine against five infections). We have begun to form a recombinant site (production of the antigens themselves) to produce vaccines on a full cycle. We follow the path of agreements with leading scientific institutions as an industrial partner. The coronavirus infection has shown that our country could quickly mobilize and produce a vaccine. Still, it is almost impossible to make the required number of doses (about 150 million) in 2-3 months because there are no such facilities in Russia. I am firmly in favour of innovation, but at the same time, for the creation of the required number of capacities for the production of biotechnological products.\"\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/94b/1.jpg"},{"tag":"COMPANY NEWS","title":"New Course of the EEU Association of Pharmaceutical Manufacturers until 2030","date":"23.10.2020","desc":"","link":"/en/news/companynews/new-course-of-the-eeu-association-of-pharmaceutical-manufacturers-until-2030/","inner_date":"23.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Participants of the press conference organized by the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (APhMEEU) discussed the focal points of collaborative efforts and strategic tasks of the organization for the next 10 years.\n</p>\n<p>\n\t The press conference was attended by Stanislav Naumov, Chairman of the APhMEEU Management Board, Andrey Ivashchenko, Chairman of the Board of Directors of ChemRar Group, Dmitry Kudlai, General Director of Generium JSC, Alexey Torgov, Director of the Department for Government Relations at BIOCAD CJSC, Peter Rodionov, General Director of GEROPHARM, Alexander Semenov, President of Aktivny Komponent JSC, Vladimir Khristenko, President of NANOLEK LLC, Grigory Potapov, General Director of Pharmstandart JSC.\n</p>\n<p>\n\t All these companies contribute significantly to the growth of the industry, the economy of Russia and the entire nation. Since 2010, the Association's member companies have built 93 new infrastructure facilities and created more than 13,000 new high-tech jobs , of which almost 1,400 relate to the research and science. The total volume of investments over the past 10 years (2010-2019) made about 71 billion rubles. A significant portion of funds, namely 22.2 billion rubles, is allocated to research projects.\n</p>\n<p>\n\t Today, the companies that are members of the Association produce 223 medicines on the VED (vital and essential drugs) list in a variety of nosologies.\n</p>\n<p>\n\t The participants of the event focused on the tendencies that are common for all the members of the Association – the markets of Russia and the EAEU as the major ones in investment and development of competencies (R&D and production). These tendencies are adhering to high quality standards and striving for the industry that presents only effective and safe drugs, ambitions to enter the global pharmaceutical market, the desire to create advanced technologies in the prevention, diagnosis, treatment and rehabilitation, likewise the innovative medicines and other medical technologies. The APhMEEU Declaration was unveiled as well.\n</p>\n<blockquote>\n\t<p>\n <b>Stanislav Naumov, Chairman of the Board of APhMEEU: </b>\"The Association today brings together Russia's strongest pharmaceutical manufacturers. Of course we pursue the aim to strengthen the Association's membership, but we are going to be very picky in this. What is important to us is the integrity of the company as a manufacturer of effective and safe drugs, origination of its fixed capital fr om Russia and the EEU, and the potential member fully sharing the principles of the Association as enshrined in the Declaration. The word \"Eurasian\" in our name is not accidental: we are the center of expertise for the formation of the unified pharmaceutical market of the EEU.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK LLC:</b> \"It is very important that today we can freely discuss pressing issues. Pharmaceuticals is one of the industries where the government chooses critical points of competence. The drug supply system is built in such a way that drugs for treatment and prevention of life-threatening diseases are purchased by state customers. Therefore, it is extremely important for pharmaceutical manufacturers to know that the product they are developing or localizing will be in demand, and the state should proactively set tasks for pharmaceutical companies in terms of the most pressing issues that need to be addressed. Our company e.g. is focused on the production of vaccines and we are willing to be part of the state policy on the implementation of national projects \"Health Care\" and \"Demography\". On the whole, APhMEEU includes companies united by a common idea, a common strategy; and this is very important as the national pharmaceutical industry can be made truly global by joint efforts only.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Alexander Semenov, President of Aktivny Komponent JSC: </b>\"The advancement of full-cycle development of pharmaceuticals is one of the strategic areas of the Association. APS (Active Pharmaceutical Substances) is the first stage of drug production and so far only about 6.5% of the market is occupied by Russian substances. As part of the Association, we are working to ensure that more players in this country's market enjoy investing in substance production. An impetus could be given by the national program within the Pharma-2030 strategy encouraging the production of APS, reagents and intermediates in Russia through provision of customs, financial and other incentives, etc. for the local manufacturers. In particular, one of the incentive tools may be state contracts for the production of drugs wh ere the substance manufacturer is one the parties thereto. It is unlikely to create a fully functional pharmaceutical industry in Russia without developing a set of measures to facilitate the production of pharmaceutical components.\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Andrey Ivashchenko, Chairman of the Board of Directors of HemRar Group:</b> \"Today, there is no need to explain to anyone why the technological sovereignty of pharmaceuticals and biotechnology is so vital for any nation. With the successful adoption of the Pharma 2020 strategy over the past 10 years, we have created our own industry and lay the groundwork for providing patients with all of the drugs they need during the pandemic, even with all the borders closed. On top of that, we were able to quickly develop and were the first company worldwide to commercialize the new COVID-19 drugs and vaccines. Everyone has seen that if there is an industry, it can get mobilized, respond to the challenges faced and tackle them. In this context, the first part of the Pharma 2020 program concerning the generic substitution of imports has been successfully completed. At the next stage, innovative development should become the main driver of Pharma 2030. This means that Russian companies must learn how to make modern high-tech drugs that will be copyright patented. This will automatically cause our pharmaceutical manufacturers to put high-margin drugs in their portfolios. Indeed, everyone has learned how to make generics, everyone is joining price competition, profits are dropping, therefore no resources for growth will remain. The innovative drugs, on the contrary, will allow the profit to be reinvested in the development of our country, not elsewhere, rather than remitting it abroad to the partners granting exclusive rights to specific innovative drugs. Accordingly, this will gear up the development of the national industry.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Dmitry Kudlai, General Director of ENERIUM JSC:</b> \"APhMEEU puts high demands on the applicant companies for membership in the Association. This organization brings together the most competent and decent participants of the Russian pharmaceutical industry that meet the international standards of GMP Good Manufacturing Practice, have a scientific base and are able to secure sales of high-quality Russian pharmaceuticals on the world's highly regulated markets. An important event this year was the full-scale introduction of labeling. Notably, the APhMEEU attendees were the first to launch labeling of medicines; something which shows that the manufacturer is 100% confident in its product. GENERIUM is a full-cycle research and production company, being a model of translational biotechnology. It fully meets all the stated requirements and creates today medicines that are first-rate “blockbusters” treating orphan illnesses. Our efforts will be even more effective should our national manufacturers of orphan products be granted more preferences.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Peter Rodionov, General Director of GEROPHARM:</b> \"The Russian market is the key one for the members of the Association, and we are fully answerable for it. Today, there are unresolved issues regarding the quality and effectiveness of certain medicines circulating in the market. Therefore, one of the most important tasks at the moment is to \"restore\" the market \"to a healthy state\" and remove all dishonest players. This is the responsibility which lies with the manufacturers themselves, the Ministry of Industry and Trade, and the Ministry of Health. What can we as an Association do is to act as the driver of this process. Moreover, today it is highly important to create competitive products that meet international standards, allowing us to be competitive in international markets. Export is a key growth point and a chance of integration into global competition while offering biosimilars, generics, and innovative products. This is one of the key tools encouraging the national market growth. Indeed, the higher exports help draw more profit and invest it in the development of a portfolio of drugs produced by national manufacturers. But to wheel it out, we need clear and effective mechanisms of state support.\"\n\t</p>\n</blockquote>\n <br>\n<blockquote>\n\t<p>\n <b>Alexey Torgov, Director of the Government Relations Department at BIOCAD CJSC:</b> \"Pharma 2020 has led to the development of innovative original medicines in Russia. The volume of these innovations can be counted on the fingers of one’s hand, and the innovations are “delicate sprouts beneath the tough regulatory system's guidelines”. We advocate that innovations are supported by the state. For the inventions to be a success, developers should be in direct contact with the regulatory authority and the expert organization that issues permits and evaluates reports. We believe that the regulator should provide full support for developers all the way from laboratory to industrial production. That is why the companies being part of the APhMEEU have prepared the suggestions for changing the system for scientific consulting and forming an expert committee consisting of several representatives of expert organizations from different countries. This is how these companies will be able to advise developers on the scope and design of clinical trials, innovation-related issues and drug quality test methods. To speed up the commercialization of innovative medicines, the APhMEEU suggests presenting in more details the conditional registration procedure based on the findings of the second phase of clinical trials.\"\n\t</p>\n</blockquote>\n <br>\n<p align=\"center\">\n\t \n</p>\n<p>\n\t The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union was registered in 2012.\n</p>\n<p>\n\t The aim of the Association is to create conditions for the development of the pharmaceutical market in Russia and other EEU countries, to reinforce the position and competitive ability of the national pharmaceutical industry.\n</p>\n<p>\n\t Members of the Association maintain their main competence centers, including research laboratories and production facilities in the Russian Federation and other EEC countries. Likewise, and have proprietary know-how and other intellectual property in the field of development and production of medicines and medical technologies. The Association includes leading full-cycle pharmaceutical companies, namely: Pharmstandart PJSC, Biocad CJSC, GEROPHARM LLC, Nanolek LLC, Polysan NTFF, Aktivny Komponent JSC, Generium JSC, high-technology center ChemRar, NatiVita Joint Venture Limited Liability Company.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/3a0/AFPEES.jpg"},{"tag":"COMPANY NEWS","title":"Participants of the \"Open innovations\" Forum discussed the issues of vaccine production and prevention","date":"22.10.2020","desc":"","link":"/en/news/companynews/participants-of-the-open-innovations-forum-discussed-the-issues-of-vaccine-production-and-prevention/","inner_date":"22.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Healthcare systems in almost all countries have faced challenges on a large scale and received an impetus for further development. The pharmaceutical industry has found itself at the forefront and feels impelled to look for innovative solutions to combat coronavirus infection (diagnosis, treatment, and now there is also the need for prevention and vaccination) 24 hours a day.\n</p>\n<p>\n\t The world's first coronavirus vaccine has already been registered in Russia. What's next? Are any changes going to happen? What conclusions will be drawn by the global community?\n</p>\n<p>\n\t These talking points were discussed by the participants of the discussion: \"Revolutionary innovations in medical science. How to create a pandemic vaccine?\"\n</p>\n<p>\n\t • Maxim Stetsyuk, Executive Director of NANOLEK),\n</p>\n<p>\n\t • Darya Egorova (senior research fellow, the N.F. Gamaleya Research Institute of Epidemiology and Microbiology),\n</p>\n<p>\n\t • Polina Stepensky (Head of the Department of Bone Marrow Transplantation and Immunotherapy for Children and Adults at Hadassah Medical Center),\n</p>\n<p>\n\t • Ilya Timofeev (Chief scientific adviser at Rusfarmtech).\n</p>\n<p>\n\t The event was moderated by Vladimir Chulanov (Deputy Director for Research and Innovative Development at the National Research Center of Phthisiopulmonology and Infectious Diseases under the Ministry of Health of Russia).\n</p>\n<p>\n\t The discussion turned out to be interesting, comprehensible, but, most importantly, action-oriented. Insights from experts who are at the center of things here and now, are looking for solutions, changing strategies, finding ways – the \"new era\" of humanity is going to become cognizant.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk:</b> \"We definitely need to bet on innovations, we need to talk about collaboration between businesses and science. A synthesis of the best minds, breakthrough solutions, production and businesses will be the basis for the continued development of a fully functional pharmaceutical industry that is ready for any challenge.\n\t</p>\n\t<p>\n\t\t If we talk about practical steps, we should mention investments in a new generation as part of the national projects \"Healthcare\" and \"Demography\". It's now already time to discuss how we can expand the National calendar of preventive vaccinations to protect our children from vaccine-controlled diseases.\n\t</p>\n\t<p>\n\t\t It is also crucial to use the lessons learned by other countries – we need to deal with immunoprophylaxis measures from the very basics: In particular, we should take note of the experiences gained by Israel. The children in Israel are educated about the importance of immunizations already at school and this is how they increase their awareness and, consequently, confidence and correct perception.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/73c/Otkr-inny-Maks.jpg"},{"tag":"COMPANY NEWS","title":"Senior executive of Nanolek becomes the winner of the Eurasian Pharma Award","date":"21.10.2020","desc":"","link":"/en/news/companynews/senior-executive-of-nanolek-becomes-the-winner-of-the-eurasian-pharma-award/","inner_date":"21.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Maxim Stetsyuk, CEO of NANOLEK, has clinched the Eurasian Pharma Award in the “Business Success” nomination.\n</p>\n<p>\n\t This is a first time in history that a competition is held this year, in 2020, among the pharmaceutical manufacturers of the Eurasian Union. 72 nominees representing 13 different countries expressed their willingness to face the challenge, considering the fact that pharmaceutical markets of these nations are on the agenda of the Eurasian Virtual Pharmaceutical Summit (Russia, Kazakhstan, Uzbekistan, Azerbaijan, Kyrgyzstan, Belarus, Armenia, Ukraine, Georgia, Moldova, Turkmenistan, Tajikistan, Mongolia).\n</p>\n<p>\n\t As stated by Natalya Bayeva, Director of the Eurasian Virtual Pharmaceutical Summit, most applications for the Eurasian Pharma Awards were filed by pharmaceutical companies to compete for “The Best Digital Project” nomination. It shows that the pharmaceutical sector witnesses a rapid development, especially amidst the challenges during the current year.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk:</b> “I’m very obliged that you value so much my professional contribution, but this victory, though in the personal nomination, is primarily due to well-coordinated work of the whole team. The greatest strength of every company is people. That is why I express my gratitude to all employees of NANOLEK who we work with together to make the company grow and develop, to pursue our mission in unchanged way: to protect people’s lives and health by making the best world technologies available to everyone. Our success is a well-balance day-to-day interaction, sometimes by working at our limits. I’m sure that many victories lie ahead of us since we have an enormous potential.”\n\t</p>\n</blockquote>\n<p>\n\t Maxim Stetsyuk has been working in the capacity of CEO at NANOLEK since 2018; in March 2020, he joined the board of Nanolek LLC. During his tenure with the company he managed to increase several times the sales, implement global structural changes by generating the company’s first profit and enabling export of drugs to the CIS countries.\n</p>\n<p>\n\t By the end of the year 2019, the enterprise’s revenue increased by 60% and amounted to 7.5 billion rubles as compared to the 2018 metric. The company’s investment volume exceeded RUB M500. The profit was 596 million rubles. The company’s tax deductions to the budget of the Kirov region amounted to 100 million rubles.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/9a7/Aw.jpg"},{"tag":"COMPANY NEWS","title":"The Federal Center status may be granted to the Research and Educational Center “Biopolis”","date":"21.10.2020","desc":"","link":"/en/news/companynews/the-federal-center-status-may-be-granted-to-the-research-and-educational-center-biopolis/","inner_date":"21.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On the 20<sup>th</sup> of October the Kirov region Governor Igor Vasilyev delivered a workshop devoted to the Research and Educational Center (REC) “Biopolis”.\n</p>\n<p>\n <br>\n\t The REC comprises: Kurchatov Institute, Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of the Russian Academy of Sciences, Russian Foundation for Basic Research, Kirov State Medical University, Vyatka State Academy of Agricultural Sciences, Vyatka State University, pharmaceutical companies “Nanolek” and “Invak”.\n</p>\n<p>\n <br>\n\t We would like to remind that the regional authorities singled out the development of the regional biopharmaceutical industry, extension of enterprises and organizations’ cooperation in view of the cluster-based policy, increase in clinical studies and their quality improvement as the main priorities of the “Biopolis”. A more global goal is development of the domestic pharmaceuticals’ market and enabling better treatment of patients. <br>\n <br>\n <b>Igor Vasilyev: </b>“The Kirov region can look back at great traditions and an enormous scientific basis; the biomedical pharmaceutical cluster is being created beneath our very eyes.” The Governor also emphasized that the world-class Research and Educational Center “Biopolis” is expected to house in future an up-to-date municipality where there is enough place for high-tech production facilities, staff training and comfortable accommodation. It will be situated in the Orichevsky district, thus fostering development of its infrastructure and the region’s well-being in general.<br>\n <br>\n <b>First Deputy Chairman of the regional government Dmitry Kurdyumov</b> mentioned that the Ministry of Science and Higher Education of the Russian Federation launched a prequalification selection, and the Research and Educational Center “Biopolis” is going to take part in it: “The application we have been completing is almost ready. We will describe there the key agenda to form the basis of what will be the REC’s short-term action program. It is primarily related to clinical studies. Besides, we will also define other projects that may be added to the principal one. We proceed with this application form to obtain an official federal approval for our Research and Educational Center. One of the application’s key tasks is not only to set up an administrative division but also to establish a special economic zone and build transport and amenity infrastructure. We are planning to include all these aspects in the program and the operational roadmap.”\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e93/NOTS.jpg"},{"tag":"COMPANY NEWS","title":"The chairman of the Board of AFPEES (Association of Pharmaceutical Manufacturers of the Eurasian Economic Union) took part in the plenary session of the V BIOTECHMED–2020 Forum","date":"17.10.2020","desc":"","link":"/en/news/companynews/the-chairman-of-the-board-of-afpees-association-of-pharmaceutical-manufacturers-of-the-eurasian-econ/","inner_date":"17.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 17, the plenary session \"Russian healthcare in the era of fight against the pandemic. Contribution of the Russian industry” was held as part of the V forum \"BIOTECHMED-2020\".\n</p>\n<p>\n\t Participants elaborated on priorities in the development of health care and measures to ensure a stable epidemiological situation in the country as well as the practical role of the industry in health care.\n</p>\n<p>\n\t The session was attended by the following officials: Mikhail Albertovich Murashko (Minister of Health of the Russian Federation), Denis Valentinovich Manturov (Minister of Industry and Trade of the Russian Federation), Sergey Viktorovich Chemezov (General Director of Rostec State Corporation), Veronika Igorevna Skvortsova (Head of the Federal Medical-Biological Agency), Veniamin Ivanovich Kondratyev (governor of the Krasnodar Krai).\n</p>\n<p>\n\t The session was moderated by Evelina Zakamskaya, editor-in-chief at Doctor TV channel and TV host at Russia 24.\n</p>\n<p>\n <b>Stanislav Naumov, Chairman of the Board of the Association of pharmaceutical manufacturers of the Eurasian Economic Union (AFPEEC)</b>, delivered one of the key messages at the session – crucial significance of vaccination as a corner stone of the national projects \"Health\" and \"Demography\". Besides, he emphasized the following point:\n</p>\n<blockquote>\n\t<p>\n\t\t \"The long-term strategy \"Pharma 2020\" has proved to be successful. This is our collective merit and I speak on behalf of 8 pharmaceutical companies (shareholders and CEOs are present in this hall). I will give some statistics: 233 INNs, 71 billion rubles are joint investments over the past 10 years, 22 billion of them are R&D investments. And the result is: 13 thousand new jobs, of which 1,400 are scientists who work at our enterprises.\"\n\t</p>\n</blockquote>\n<p>\n\t AFPEES includes leading full-cycle pharmaceutical manufacturers: Pharmstandart PJSC, Biocad CJSC, GEROPHARM LLC, Nanolek LLC, NTFF Polisan, Active Component JSC, Generium JSC, HTC ChemRar, Nativita JV LLC, Karaganda pharmaceutical plant LLP.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/ba2/Bez-nazvaniya.png"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk, Executive Director at NANOLEK, takes part in the business program of the V Forum “Biotechmed”","date":"15.10.2020","desc":"","link":"/en/news/companynews/maxim-stetsyuk-executive-director-at-nanolek-takes-part-in-the-business-program-of-the-v-forum-biote/","inner_date":"15.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Participants of the online panel “Issues of preventive immunization and vaccine production” discussed the search for quick solutions to create vaccines against COVID-19, the strategy for the development of preventive immunization against infectious diseases until 2035, planning a horizon in vaccine production, technology transfer, clinical research and other pressing issues.\n</p>\n<p>\n\t The discussion was co-moderated by: Evelina Zakamskaya (Editor-in-Chief at the “Doctor” TV channel), Elena Denisova (Deputy Director of the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation), Konstantin Chernov (Deputy General Director for Design Activities and Innovations at the Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences). Following experts were invited to join the panel: Viktor Fisenko (Deputy Minister of Health of the Russian Federation), Vadim Tarasov (Director of the Institute of Translational Medicine and Biotechnology at the I.M. Sechenov First Moscow State Medical University), Elena Sakanyan (Director of Science at the Scientific and Production Association “Microgen”), Victor Trukhin (Director of the Federal State Unitary Enterprise “St. Petersburg Scientific Research Institute of Vaccines and Serum and Enterprise for the Production of Bacterial Preparations) and Maxim Stetsyuk (Executive Director at Nanolek) .\n</p>\n<p>\n\t Many highly dangerous infections (poliomyelitis, smallpox, etc.) have been eradicated or are under control at present, but the humanity quickly forgets the risks. The WHO believes that one of the biggest threats in today's world is the vaccine rejection. The panelists elaborated on the situation regarding protection of the population from infections using the example of the coronavirus pandemic. A reliable and timely protection of the population can be achieved only through joint and well-coordinated collaboration between all market players. Vaccine development is a complex long-term process involving developers, manufacturers and regulatory agencies.\n</p>\n<p>\n\t One of the important steps in this direction was the approval of the 15-Year Strategy for the Development of Preventive Immunization by the Government – the document developed by order of the President of Russia and defining an plan of activities for the next 15 years, until 2035. The strategy focuses on the immunization to get protected against a variety of infections and assumes that the preventive vaccination will cover at least 95% of the population. This is exactly the percentage that helps achieve a significant effect from vaccine prophylaxis.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk, Executive Director at NANOLEK, noted in his speech:</b> “For manufacturers, the Strategy for the Development of Preventive Immunization until 2035 now approved has become a very important milestone. In this case, COVID-19 can be seen as an impulse to boost the growth of the pharmaceutical industry. Indeed, the WHO included a rejection of of vaccines to the list of 10 major threats to humanity. As manufacturers, we acknowledge that immunization is a cost-effective step towards protecting people’s life and health: 1 ruble invested in vaccination equals 16 times the budget saving effect in the future.\n\t</p>\n\t<p>\n\t\t Currently, a road map is being developed as part of the Strategy to ensure the sustainability and the most transparent planning of the system. We believe we should stick to long-term planning. It is crucial to reinforce the practice of signing state contracts for longer periods (3, 5, 7 years). The 2-year contract which regulates our supplies of vaccines since 2019, for example, has proved to be effective: cyclical production, early planning, no regional shortages, and contract performance according to the set deadlines in a pandemic context.\n\t</p>\n\t<p>\n\t\t What can manufacturers do in return is, first of all, to keep their operations going according to internationally recognized GMP standards, to localize and produce patented state-of-the-art vaccines. E.g. combination vaccines that can protect a child from numerous vaccine-preventable diseases at the same time, thus decreasing the number of injections required and reducing visits to health care facilities.”\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/483/Maksim-v-btm.jpg"},{"tag":"COMPANY NEWS","title":"Representatives of NANOLEK discussed the issues related to quality, measures to counteract counterfeit and forged medications","date":"09.10.2020","desc":"","link":"/en/news/companynews/representatives-of-nanolek-discussed-the-issues-related-to-quality-measures-to-counteract-counterfei/","inner_date":"09.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 8, the video conference \"Medicines: quality issues, measures to counteract counterfeit and forged products\" was held.<br>\n <br>\n\t The event was organized by the Ministry of Industrial Policy of the Kirov region as part of the Six-party agreement on detection, prevention and suppression of illegal commercialization of industrial products.<br>\n <br>\n\t Alexey Pavlov, Head of the Quality Management Department at NANOLEK, and Andrey Kolupaev, a leading expert in IT support, delivered a report on the hands-on experience in implementation of drug labelling requirements at NANOLEK biomedical complex.<br>\n <br>\n\t They met the experts from Rospotrebnadzor (Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing), Roszdravnadzor (Federal Service for Surveillance in Healthcare) and other representatives of pharmaceutical providers in the Kirov region.<br>\n <br>\n\t Statutory requirements on labelling of medications have become mandatory on July 1, 2020 for all participants of the pharmaceutical industry – manufacturers, distributors, pharmacies and healthcare providers concurrently with the large-scale launch of the monitoring systems.<br>\n <br>\n\t Our colleagues told us how and within which time limits the project for drug labelling in the MTM system (medication traffic monitoring) was implemented at NANOLEK biomedical complex.<br>\n</p>\n<blockquote>\n\t<p>\n <b>Alexey Pavlov:</b> \"NANOLEK has managed to meet the deadline for launching the labelling project imposed by the regulatory authority. On November 21, 2019, NANOLEK biomedical complex in Kirov region manufactured a labelled commercial batch of Hunteraza® drug used to treat the mucopolysaccharidosis type 2 (MPS 2) included in the 14 Nosologies List.\n\t</p>\n\t<p>\n <br>\n\t</p>\n\t<p>\n\t\t In April 2020, we successfully performed a state contract on labelling of Darzalex® (Daratumumab) used in the treatment of multiple myeloma.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/87e/Pavlov-i-Klupaev.jpg"},{"tag":"COMPANY NEWS","title":"Sergey Tolstobrov, Director of the Department of Economic Territory Development at NANOLEK, takes part in the event organized by the Vyatka Chamber of Commerce and Industry in Kirov","date":"07.10.2020","desc":"","link":"/en/news/companynews/sergey-tolstobrov-director-of-the-department-of-economic-territory-development-at-nanolek-takes-part/","inner_date":"07.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Sergey Tolstobrov, Director of the Department of Economic Territory Development at NANOLEK, took part in the round table discussion \"Marketing strategies of biotechnological and biopharmaceutical companies\". The event was held on October 7 on the premises of the business center of the Vyatka Chamber of Commerce and Industry in Kirov.\n</p>\n<p>\n\t This was the first meeting in a series of gatherings (there will be four such meetings) held for participants of the biopharmaceutical cluster \"Vyatka-Biopolis\" and other biotechnological clusters of the Kirov region.\n</p>\n<p>\n\t Participants discussed the following topics: peculiarities of building a unique marketing strategy and its implementation, advertising and promotion of products manufactured by the biotechnological and biopharmaceutical companies; finding a customized approach to the development of a marketing strategy for companies of the biopharmaceutical cluster in the Kirov region.\n</p>\n<p>\n\t The event was supported by the Ministry of Economic Development of the Russian Federation, the government of the Kirov region and the Ministry of Economic Development and Support for Entrepreneurship of the Kirov region as part of the National project \"Small and medium-sized businesses and support for individual business initiatives\".\n</p>\n<blockquote>\n\t<p>\n <b>Sergey Tolstobrov: </b>\"NANOLEK is one of the founders of the Vyatka-Biopolis cluster that primarily focuses on helping small health care businesses. As an anchor participant, NANOLEK actively supports its cluster partners and facilitates the development of small biotechnological businesses in the Kirov region.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/853/VTTP.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK's project shortlisted for the InterComm 2020 award","date":"06.10.2020","desc":"","link":"/en/news/companynews/nanolek-s-project-shortlisted-for-the-intercomm-2020-award/","inner_date":"06.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 6, the list of companies nominated for the InterComm 2020 intra-corporate communications award was published.\n</p>\n<p>\n\t NANOLEK's project \"Make a healthy lifestyle!\" has been shortlisted in the \"Lifestyle\" nomination. It is symbolic that October has been declared the month of healthy lifestyle in NANOLEK. In-house communications play a vital role in the life of every company during a pandemic. Despite remote work, movement restrictions and mask wearing rules, it is important to find an opportunity to unite, inspire, motivate employees and, most importantly, not to fall into panic.<br>\n <br>\n\t We extend our congratulations to the companies added to the list, and we wish everyone a successful face-to-face defence which is expected to take place on October 13.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/364/Interkom.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is included in the National register of \"Leading organizations of industrial infrastructure in Russia\"","date":"02.10.2020","desc":"","link":"/en/news/companynews/nanolek-is-included-in-the-national-register-of-leading-organizations-of-industrial-infrastructure-i/","inner_date":"02.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t As recommended by the Ministry of industrial policy of the Kirov Oblast, NANOLEK was included in the National register of \"Leading organizations of industrial infrastructure in Russia\".\n</p>\n<p>\n\t The register contains industrial enterprises that hold leading positions in their industry and make a significant contribution to the socio-economic development of the region. Nanolek was added to the Register based on proposals by the government and municipal authorities.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/815/khren.jpg"},{"tag":"COMPANY NEWS","title":"Alexey Pavlov, Director of the NANOLEK Quality Management Department, speaker of the V All-Russian GMP conference","date":"01.10.2020","desc":"","link":"/en/news/companynews/alexey-pavlov-director-of-the-nanolek-quality-management-department-speaker-of-the-v-all-russian-gmp/","inner_date":"01.10.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Alexey Pavlov, Director of the Department of Quality Management at NANOLEK, took part in the round table discussion \"Specifics of the production of immunobiological drugs\", held as part of the V All-Russian GMP conference.\n</p>\n<p>\n\t The thematic event was moderated by Elena Denisova (Ministry of Industry and Trade of Russia) and Irina Novikova (GMP news magazine). Following speakers were invited to participate: Elena Makarova (MSD Pharmaceuticals), Stanislav Uyba (Mechnikov Institute), Stanislav Afanasiev (FORT), Mikhail Tsyferov (NPO Petrovax Pharm) and other representatives of pharmaceutical companies.\n</p>\n<p>\n\t The colleagues had a chance to discuss the issues of concern: development of production of immunobiological drugs in the Russian Federation and technology transfer, production cooperation, specifics of logistics, experience in inspecting production facilities and examples of cooperation between the Russian and foreign companies. Besides, the participants answered questions asked by the moderators.\n</p>\n<p>\n\t Alexey Pavlov shared his experience in localizing the production of the Pentaxime ® vaccine, told about technology transfer, stages of cooperation, quality guarantees, ins and outs of import substitution and important peculiarities of the production of immunobiological drugs.\n</p>\n<p>\n\t NANOLEK is implementing this project jointly with its French counterparts from Sanofi Pasteur. The vaccine is included in the National preventive vaccination calendar and protects children from five dangerous infections: diphtheria, tetanus, pertussis, polio, and infections caused by Hemophilus influenzae type B (HIB).\n</p>\n<p>\n\t You need to follow a number of regulations before proceeding to work with an international partner: you have to make sure that all requirements of both parties are met, and any contradictions with the legislation of both countries and in-house regulations of each of the companies are ruled out, and the equipment in the production facility is checked thoroughly by an international partner and local regulators. Checks are made at different stages and at all levels, which gives grounds for confidence that the NANOLEK production facility meets high GMP standards.\n</p>\n<blockquote>\n\t<p>\n <b>In his speech Alexey Pavlov emphasized the first-rate importance of the ability to work in a team: </b>\"I believe that we have managed to create a highly effective team of highly qualified professionals - one for both companies - which gives us an opportunity to move gradually forward, towards achieving our common goals set at the very beginning of this long and fruitful path. The success of any project depends on how professionally, carefully and systematically both parties will deal with solving these issues. If every participant understands the significance of their job and importance of their contribution to the common cause, if everyone realizes what targets we should strive for, and what benefits they will bring to the whole society, then such an undertaking will be guaranteed success.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bd3/AP.jpg"},{"tag":"COMPANY NEWS","title":"Experts discuss the First Efforts in implementing the Immunoprophylaxis Strategy until 2035","date":"29.09.2020","desc":"","link":"/en/news/companynews/experts-discuss-the-first-efforts-in-implementing-the-immunoprophylaxis-strategy-until-2035/","inner_date":"29.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On September 25, 2020, the press center of MIA \"Russia today\" hosted an online expert discussion \"Culture and immunoprophylaxis system: development focus amidst global challenges\" which took place shortly before government's plans to approve the strategy for immunoprophylaxis of infectious diseases until 2035 (hereinafter referred to as the Strategy).\n</p>\n<p>\n\t The discussion was focused on following main topics: development of immunoprophylaxis planning and implementation measures, efforts to enhance commitment of citizens to vaccination. The discussion was attended by representatives of the Federation Council and the State Duma, experts of the Ministry of Health, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor), representatives of the pharmaceutical industry.\n</p>\n<p>\n\t\"Prevention of infectious diseases, like any other system, is based on planning, organization, implementation and control,\" said <b>Alexander Plakida</b>, discussion's moderator, Executive Director of the \"Effective healthcare\" platform and adviser to the vice rector of RANEPA. However, I believe the red line in our conversation is the issue of vaccination culture as the focus of strategic development of the entire system.\"\n</p>\n<p>\n <b>Vladimir Chulanov</b>, the chief freelance expert on infectious diseases of the Russian Ministry of health, dwelled on the development of the National preventive vaccination calendar (NPVC). He particularly emphasized the interdepartmental communications between the representatives of Rospotrebnadzor, Roszdravnadzor, the Ministry of Industry and Trade and leading industry experts. Joint activities resulted in preparation of a draft Strategy.\n</p>\n<p>\n\t Priority areas for improving the NPVC are the universal use of inactivated polio vaccine, ensuring vaccination of all children against Haemophilus influenzae type B, vaccination against rotavirus infection, human papillomavirus (hereinafter referred to as HPV), chickenpox, meningococcal infection and revaccination against pertussis, quadrivalent influenza vaccine. The Strategy also aims to ensure the availability and affordability of high-quality vaccines, pharmacoeconomic research, budget planning, and enhanced commitment to immunoprophylaxis.\n</p>\n<p>\n\t<b>Ayrat Farrakhov</b>, member of State Duma, stressed the importance of planning efforts for immunoprophylaxis. According to Mr. Farrakhov, legislative regulation today can do a lot to improve people's trust in vaccination. Besides, the expert pointed out that in previous years the budget included higher expenses for vaccination. He also expressed confidence that the budgetary framework will remain the same in 2021 and the planned period.\n</p>\n<p>\n\tIn the opinion of <b>Alexander Gorelov,</b> Deputy Director of the Central Research Institute of Epidemiology of Rospotrebnadzor, adopting a National vaccination calendar for adults and post-vaccination status monitoring measures have become a particularly urgent issue. <b>Leila Namazova-Baranova</b>, President of the Union of pediatricians of Russia and a member of the Working party on immunoprophylaxis of infectious diseases under the Ministry of health, supported the statement on the development of the NPVC through expansion of the list of infections against which Russian citizens are vaccinated, age and professional groups, e.g. health care workers not included in the pneumococcal disease risk groups. The expert also spoke in favour of efforts aimed to accelerate changes to the vaccination plan amidst epidemiological challenges.\n</p>\n<p>\n\t<b>Frederic Jumel</b>, Head of Sanofi Pasteur Business Unit in the Eurasian region, noted the importance of partnership between the government, businesses, expert communities and society on the development of the immunoprophylaxis system. The main goal of this partnership should be children's health as the main investment in the future of our nation. In particular, the expert paid special attention to vaccine supply issues, with due consideration of long-term planning opportunities. The implementation of this tool will ensure continuity of supplies and timeliness of vaccination. According to him, when solving strategic tasks in healthcare, the implementation of long-term contracts has a positive impact on the timely production of vaccines in the required amounts and sustainability of supplies. The use of modern multicomponent combined vaccines helps increase the vaccination coverage and effectively control the spread of infectious diseases as well as reduce the number of injections and the number of visits to healthcare centers, which is especially important during a pandemic.\n</p>\n<p>\n\t According to <b>Vladimir Khristenko</b>, President of NANOLEK, the COVID-19 pandemic has unveiled systemic response and planning issues: \"The more responsible-minded approach we take in planning, the easier it will be for us to address the challenges. It normally takes at least 5 years from the idea to regular production provided that the necessary technology is available (if we talk about a vaccine). And in some extreme cases, planning turns into a critical process. Under these circumstances, a vaccine production development roadmap could be of great assistance as a hands-on document to specify a timeframe for inclusion of infections in the NPVC. This will ensure the stability and most transparent planning of the system.\"\n</p>\n<p>\n <b>Anton Katlinsky</b>, science adviser at Natsimbio, elaborated on the theme and mentioned estimates based on WHO data pointing out the impossibility to guarantee sufficient production volumes and availability of vaccines without planning in a 5-7 years perspective: \"Manufacturers must have an agreement on long-term cooperation and sales guarantees for a period of five or more years with their main customer - the state - if they wish to to reach fundamentally new production targets in Russia and update the NPVC.\"\n</p>\n<p>\n\t Following on the discussion of a long-term cooperation, <b>Andrey Lomakin</b>, First Deputy General Director of the FORT biopharmaceutical company, shared the details about a joint project with MSD: \"In 2019, we agreed that we will launch a joint project to localize the production of vaccines for the prevention of rotavirus infection, chickenpox and HPV using the facilities of the FORT plant. This project aims to upgrade the plant and boost production capacity so as to start over the next few years global supplies of modern vaccines which have proven their effectiveness and safety.\"\n</p>\n<p>\n\tWhen we are talking about the vaccination culture, we can not sidestep a new wave of speculations about immunization.\n</p>\n<p>\n\t The Ministry of health will soon add a special vaccination section to its website. This resource is very important when it comes to increasing awareness among citizens. <b>Vladimir Chulanov</b> said that the working party on immunoprophylaxis of infectious diseases, the independent expert committee of the Union of experts in immunoprophylaxis, representatives of pharmaceutical companies are expected to get involved in the development of this communication channel. There are also plans to conduct a study to explore the causes of public wariness towards vaccines.\n</p>\n<p>\n <b>Tatyana Kusayko</b>, representative of the Federation Council, drew attention to the importance to increase awareness among all age groups as the formation of a vaccination culture begins in childhood, and parents' informedness plays a significant role. Research \"Perfect calendar: development of the immunization program as a public healthcare priority\" revealed that physicians are the core group to influence the decision-making in vaccination issues. The participants of discussion also agreed on the need to review educational standards for physicians so that people learn from the aspects and importance of vaccination mainly from the qualified professionals.\n</p>\n<p>\n\t Regarding the responsibility for spreading false information about vaccination, <b>Ayrat Farrakhov</b>, member of State Duma, said both the source of information and resources publishing it must assume such responsibility. According to Farrakhov, it is important not to spiral into censorship, to ensure the openness of the discussion, including about possible post-vaccination side effects.\n</p>\n<p>\n <b>While commenting on the main Strategy development areas, the experts made the following conclusions:</b>\n</p>\n<p>\n\t · The mechanism of long-term contracts being a part of immunoprophylaxis planning measures guarantees the timely supplies of required vaccine amounts.\n</p>\n<p>\n\t · It is necessary to accelerate the process of making changes to the NPVC to have the ability of rapid response to epidemiological challenges and to create a unified procedure for justification of decisions on such amendments.\n</p>\n<p>\n\t · Verified and unbiased information about immunoprophylaxis should be easily accessible to citizens. Skilled medical professionals only should conduct awareness-raising activities.\n</p>\n<p>\n\t · An implementation of digital registration mechanisms will make it easier to record, collect and analyse data on the coverage and progress of immunoprophylaxis and post-vaccination follow-up efforts.\n</p>\n<p>\n\t · Prevention of infectious diseases is one of their priority goals in maintaining good public health. We should also explore the issue of responsibility for spreading false adverse information about vaccinations that endangers the viability of prevention projects.\n</p>\n<p>\n\t · We should not cut the current funding for the vaccine prevention program within the three-year budget horizon.\n</p>\n<p>\n\t \n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/296/VV-s.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK has been awarded the first market authorizations for export to Uzbekistan","date":"28.09.2020","desc":"","link":"/en/news/companynews/nanolek-has-been-awarded-the-first-market-authorizations-for-export-to-uzbekistan/","inner_date":"28.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Market authorizations for the drugs \"Nebivolol-Nanolek\" and \"Ramipril\" were issued by the Ministry of health of the Republic of Uzbekistan. Market authorizations shall remain valid for a period of 5 years.\n</p>\n<p>\n\t Nebivolol-Nanolek is used to treat arterial hypertension, coronary heart disease, and angina of effort. Apart from treatment of hypertension, Ramipril is used for the treatment and prevention of myocardial infarction, diabetic nephropathy, diffuse renal diseases and chronic heart failure.\n</p>\n<p>\n\t The Republic of Uzbekistan became the fourth export country in a row. Earlier, NANOLEK received market authorizations for various drugs intended for export to the Republic of Belarus, the Republic of Kazakhstan and the Republic of Azerbaijan.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk, Executive Director of NANOLEK:</b> \"These market authorizations will help us expand the territory of our export shipments, which is a sign that our products are in demand outside of Russia.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/2a5/Uzbekistan.jpg"},{"tag":"COMPANY NEWS","title":"Yulia Deeva, Director of Corporate Communications at NANOLEK - speaker at Mediasreda held by Interfax","date":"23.09.2020","desc":"","link":"/en/news/companynews/yulia-deeva-director-of-corporate-communications-at-nanolek-speaker-at-mediasreda-held-by-interfax-/","inner_date":"23.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tYulia Deeva, Director of Corporate Communications at NANOLEK, took part in the traditional Mediasreda meeting organized by Interfax.<br>\n <br>\n The speakers discussed the following topic: \"PR expert as a leader: effective team management and working with executives\".<br>\n <br>\n The conversation turned out to be informative and productive. How to effectively manage a press service or PR department, how to develop internal communications within a company, how to work with an executive?<br>\n <br>\n It is a great piece of luck when you can listen to speakers having extensive experience of working in large companies, learn about the path of professional career, \"bottlenecks\" and pitfalls, about complex issues and challenges, and even based on personal examples from working life. This was told at the meeting by Yulia Mikhailova, director of the SCAN project, Interfax Group; Galina Kushnaryova, coach, speaker, author of articles in Forbes Woman, Glamour, Marie Claire, HR Director; Vladimir Zaluzhsky, Head of Communications and Investor Relations, Severstal Group; Yulia Deeva, Director of Corporate Communications at NANOLEK pharmaceutical company.<br>\n <br>\n Some insights:<br>\n <br>\n • If you wish to be successful, train your persuasion skills <br>\n <br>\n • Prepare counterevidence – be always ready to answer tough questions<br>\n <br>\n • A PR expert doesn't need to have an industry-specific fundamental educational background. The most important thing is the desire to always learn new things, to have a spacious and inquisitive mind and competencies in a number of areas (related and far different areas)<br>\n <br>\n • You need to be a bit of a psychologist to work with a company's executive: it is crucial to \"catch the right wave\" and create the most comfortable environment for it. Someone likes to act in front of the public and enjoys it, while others find it easier to give written comments<br>\n <br>\n • A PR expert as a doctor: tell him the truth about everything, and he will suggest what to do with it<br>\n <br>\n • Develop a PR strategy and speaker map to facilitate the work with the media, your company's employees, and members of the professional community.<br>\n <br>\n<blockquote>\n <b>Yulia Deeva: </b>\"A PR expert should not parade itself in front of the company, keep in mind that we should stay focused on promoting a company or a specific person. This is our job, if you say so, a PR expert is a back office who follows the strategy, brings the company to the foreground. My advice to those wishing to become PR professionals: make your agreements \"on shore\". Needs and opportunities have to match and not contradict each other.\"\n</blockquote>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/62b/Mediasreda-say.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK - a Partner of the Crimean Priboi All-Russian Oncological Congress","date":"21.09.2020","desc":"","link":"/en/news/companynews/nanolek-a-partner-of-the-crimean-priboi-all-russian-oncological-congress/","inner_date":"21.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Congress was held in Alushta on September 17-19, 2020, as part of the 5th specialized medical exhibition \"Healthcare. Crimea 2020\". The scientific organizer of the event was the Crimean Republican Oncological Clinical Dispensary named after V.M. Efetov\".\n</p>\n<p>\n\t Congress's objective was to exchange experience, demonstrate science and technology's achievements, and introduce the latest technologies, materials, and newest medications in oncology treatment. Among the Congress and exhibition participants are representatives of the Ministry of Health of the Republic of Crimea, various healthcare organizations, chief doctors and executives of hospitals, pharmacists, medical personnel, top freelance specialists, and other professional representatives.\n</p>\n<p>\n\t NANOLEK took part not only in the exhibition exposition with the demonstration of drugs for the treatment of oncological diseases, but also became a partner of the discussion platform. In particular, NANOLEK, as part of the \"Oncohematology and Vascular Surgery\" section, supported the report of Arshak Vardanovich Vardanyan (Professor of the Department of Surgery, State Budgetary Educational Institution of Higher Professional Education Russian Medical Academy of Continuing Professional Education, MD). He made a report on the topic named \"Venous Thrombosis in Cancer Patients: How to Prevent, How to Treat Being Guided by Modern Recommendations\", demonstrating the experience of using the drug Zibor in their practice (NANOLEK company is its official distributor).\n</p>\n<p>\n\t NANOLEK takes an active part in specialized events to integrate knowledge, exchange experience, and discuss existing problems. The result of such work is always a stimulating effect on the further development of a particular health sector.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/264/Krym.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Is Included in the TOP-1000 Russian Managers Ranking","date":"15.09.2020","desc":"","link":"/en/news/companynews/nanolek-is-included-in-the-top-1000-russian-managers-ranking/","inner_date":"15.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Vladimir Khristenko, President of NANOLEK and Maxim Stetsyuk, executive director of the company, were included for the second year in a row in the TOP list of best managers in Russia, the Russian Association of Managers.\n</p>\n<p>\n\t The TOP list consist of leaders from different business areas, who, through their achievements, have proved not only their professional reputation but also their ability to meet the current challenges. The primary principle taken as a basis of the ranking for many years is as follows: \"The best sel ect the best.\" The experts are all the finalists of the past years' award and the current members of the Association of Managers (more than 150 participants). The list is annually updated by approximately 40-50%. This year, this figure has not been exceeded, which indicates the stability of business to a turbulent external environment.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk, Executive Director of NANOLEK:</b>\n\t</p>\n\t<p>\n\t\t \"NANOLEK is practically the youngest pharmaceutical company. We are only nine years old, and we have been in this list for two years now. I congratulate all my colleagues from the pharmaceutical industry on adding to the list. It is especially important to note that our work was acknowledged in this year as activities of pharmaceutical companies grab the headlines in these challenging times. I wish you good luck and, of course, new interesting projects. I want to say a huge 'thank you' to the entire NANOLEK team. Membership in the \"TOP-1000\" list resulted fr om well-coordinated everyday work. I am sure that there are still many successes ahead as we have great potential. Dear colleagues, you are the best!\"\n\t</p>\n</blockquote>\n<h3>\nTHE COMPANY'S ACHIEVEMENTS are THE BEST proof of THE DIRECTOR'S statement </h3>\n<p>\n\t In 2020, NANOLEK was included in the list of systemic companies of the Russian economy. The decision to add the organization to the list was made by the government commission to improve the sustainability of the Russian economy's development. The industry list was posted on the website of the Ministry of Industry and Trade of Russia on April 25, 2020.\n</p>\n<p>\n\t Besides, NANOLEK became the winner of the Platinum Ounce Award in the Vector of the Year nomination, sub-nomination \"Project of the Year. Business Project\" and received an award for establishment of a small investment company - Invac - jointly with the Chumakov Scientific Center, which will produce full-cycle vaccines to immunize the Russian citizens according to the National Vaccination Schedule. The first project of MIP Invac was the production of a fully domestic polio vaccine, which was submitted for registration in April 2020. As soon as vaccine is released for production, we will be able to uninterruptedly supply a highly efficient and safe vaccine included in the list of the National Vaccination Schedule to the citizens of the Russian Federation.\n</p>\n<p>\n\t In early September, NANOLEK was added to the first Forbes ranking \"The Best Russian Pharmaceutical Companies\".\n</p>\n<p>\n\t All these achievements became possible thanks to the well-coordinated work of both the Moscow office and the biopharmaceutical production in the Kirov Region, which, even during the pandemic, did not suspend its operations for a single minute.\n</p>\n<p>\n\t Traditionally, the TOP-1000 list is published in the media of the Kommersant publishing house (you can read the full version by clicking on the \"Source\" button).\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/b2a/TOP-1000.jpg"},{"tag":"COMPANY NEWS","title":"The Executive Director of NANOLEK Takes Part in the 12th International Conference \"What is Happening in the Pharmaceutical Market?\"","date":"15.09.2020","desc":"","link":"/en/news/companynews/the-executive-director-of-nanolek-takes-part-in-the-12th-international-conference-what-is-happening-/","inner_date":"15.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The conference was held on September 14, 2020 in Moscow and brought together different pharmaceutical industry experts in one place: experts from state authorities, manufacturers, distributors, and pharmacy retail sector.\n</p>\n<p>\n\t Despite the variety of topics discussed at the event, the pandemic became a cross-cutting issue in all disputes. Now, following six month of massive invasion of COVID-19 in all countries' economies, we can already draw the first confident conclusions and build hypotheses for the further development of the market (including the pharmaceutical one) based on analytics and accumulated data sets. The experts shared their observations, strategies for development and on how to overcome obstacles in taking adaptive crisis-response measures.\n</p>\n<p>\n\t The central questions that were discussed at the \"What is Happening in the Pharmaceutical Market?\" Conference – were the following: how big was the impact of the pandemic on the \"PHARMA-2030\" strategy? Are the goals and objectives of this strategy to be revised? How does the government support the pharmaceutical industry? Paradigm shift: new markets, new suppliers, new channels and sales formats; national safety net: production of substances in Russia - the first steps towards independence from imported products; amendments to regulations and measures to ensure profitability of drug production; and some other topics.\n</p>\n<p>\n\t Maxim Stetsyuk, Executive Director of NANOLEK, took part as a speaker in the discussion \"COVID-19 as the Main Threat to the Implementation of National Projects in 2020\" jointly with Alexey Alekhin (Director of the Department of Development of the Pharmaceutical and Medical Industry, Ministry of Industry and Trade of Russia), Alexander Semenov (“Active Component“), Rustem Muratov (Alium), Vladimir Shipkov (AIPM) and others.\n</p>\n<p>\n\t On the one hand, the panelists noted that the coronavirus highlighted industry-specific problems in pharmaceuticals, for example, dependence on imported substances. The borders with India and China were closed; air traffic was discontinued. And there was urgent need for production sites in Russia that would remove this dependence and produce drugs in a full cycle, including API. But on the other hand, the speakers noted a well-coordinated work of the regulatory agencies - the Ministry of Health and the Ministry of Industry and Trade in solving the arising problems. All market players kept a dialogue constantly active which finally helped to address existing issues, open up new opportunities, and provide positive impact on its development.\n</p>\n<blockquote>\n\t<p>\n <b>Maksim Stetsyuk, Executive Director of NANOLEK, expressed his point of view:</b>\n\t</p>\n\t<p>\n\t\t \"NANOLEK is an active participant in the pharmaceutical market. One of our main tasks is the uninterrupted production and supply activities. We were able to successfully complete this task during this challenging period.\n\t</p>\n\t<p>\n\t\t Now it is time for every pharmaceutical company to decide on its strategy. Undoubtedly, the PHARMA-2030 project is vital in terms of making the country more independent from from foreign suppliers of raw materials. Russia has every chance to set up a full -cycle pharmaceutical production plant.\n\t</p>\n\t<p>\n\t\t I would like to note that the list of strategically essential medicines, which should be manufactured in the Russian Federation, has been revised lately (for the first time since 2010). This list now contains 215 drugs. It must include all vaccines of the National Vaccination Schedule (NVS) and the calendar for epidemiological indications. It is highly important that the government starts paying close attention to vaccination issues.\n\t</p>\n\t<p>\n\t\t We should actively discuss the need to expand the NVS, by adding vaccinations against meningococcal infection, chickenpox, HPV, and to broaden the use of vaccines against haemophilus influenza type-b in all children. The issue is very complex and we certainly need to hammer out all the details relating to the production or localization of such vaccines. It is important to underline that launch of new vaccine localization projects helps gain new hands-on experience and new competencies, ensures the growth and development of pharmaceutical production with due regard to high technological requirements, gives an impetus for the development and implementation of in-house innovations to guarantee the national independence from imported products in the future.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/710/M-_1_.jpg"},{"tag":"COMPANY NEWS","title":"Champions of the second quarter receive awards from NANOLEK","date":"14.09.2020","desc":"","link":"/en/news/companynews/champions-of-the-second-quarter-receive-awards-from-nanolek/","inner_date":"14.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On September 10, the II quarter Champions were given their awards at the NANOLEK biomedical complex. The Company's Championship program is an incentive tool of the HR department to encourage and motivate team members.<br>\n\t ⠀<br>\n\t Mikhail Sergeevich Nekrasov, CEO of NANOLEK, handed over certificates, badges of merit and branded gifts to employees. They symbolise their diligence and contributions to the development and improvement of the Company's processes.<br>\n\t ⠀<br>\n\t We wish to congratulate and convey thanks to Evgeny Durnev, Denis Komarov, Oksana Kulikova, Natalia Mikryukova and Vyacheslav Shuklin. Please do not rest on your oars and strive to conquer new heights together with NANOLEK!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/8f0/CHempion-sent-2020.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK takes part in the \"Race of heroes\"","date":"07.09.2020","desc":"","link":"/en/news/companynews/nanolek-takes-part-in-the-race-of-heroes/","inner_date":"07.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t September 5, 2020 saw in Tula, to say the least, a real adventure for members of NANOLEK_TEAM from Moscow and Kirov. \"Barbed wire\", \"Born again\", \"Everest\" - the names of the trials speak for themselves. Participants of the Race climbed a steep mountain using ropes, crept, swam across a moat filled with water, and besides overcame almost 30 different tests. High-energy vibes and thrill, courage and overcoming, power and unity - all this marked the first corporate Race of NANOLEK Heroes.\n</p>\n<p>\n\t Such initiatives became a natural result of the corporate program \"It's time to start a healthy lifestyle\". NANOLEK actively promotes a healthy lifestyle. Employees of the Moscow office and the biomedical facility in Kirov attend various classes, and go in for CrossFit, which is a corporate sport.\n</p>\n<p>\n\t Sports spirit goes along with competitiveness, which is why our colleagues regularly take part in various contests. \n</p>\n<p>\n\t We recommend that you watch a video capturing the \"Race of heroes\" as evidence of respectable fight of the NANOLEK team (you can watch the video by clicking on the \"Source\" button).\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/456/Gonka.jpg"},{"tag":"COMPANY NEWS","title":"Forbes publishes first ranking of Russian top pharmaceutical companies","date":"01.09.2020","desc":"","link":"/en/news/companynews/forbes-publishes-first-ranking-of-russian-top-pharmaceutical-companies/","inner_date":"01.09.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The leading domestic pharmaceutical manufacturers were included in the list. NANOLEK ranked 19th. The long-listed companies match the industrial parameter “Production of medicinal products and materials for humans use”.\n</p>\n<p>\n\t The assessment used the weights method and was based on five criteria: revenue for 2019; changes in annual revenue; net profit; number of medicinal products for which marketing authorizations were issued per company and the number of clinical study permits issued in favor of the company.\n</p>\n<p>\n\t Financial performance was collected from public sources in the SPARK system; information on marketing authorization issue and clinical study permits - from the State Register of Medicinal Products (data as of August 5, 2020).\n</p>\n<p>\n\t We congratulate employees of NANOLEK, colleagues and partners!\n</p>\n<p>\n\t We wish you conquering new peaks!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/5a6/Forbes.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK renders assistance to Spas-Talitsa orphanage in the Kirov region","date":"31.08.2020","desc":"","link":"/en/news/companynews/nanolek-renders-assistance-to-spas-talitsa-orphanage-in-the-kirov-region/","inner_date":"31.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On the eve of the new school year, the company's employees visited a supported orphanage in Spas-Talitsa located in the Orichi district of the Kirov region.\n</p>\n<p>\n\t On August 13, 2020, CEO of NANOLEK Mikhail Nekrasov made a study trip to the orphanage in order to get to know the management. The parties discussed the scope of necessary assistance at a joint meeting and an official meeting was followed by acquaintance with boys and girls living in the house and presentation of gifts.\n</p>\n<p>\n\t A few days after the visit, laminate flooring was installed in the assembly hall of the orphanage, and on the eve of September 1, the necessary school supplies were handed over to future first-graders. ⠀\n</p>\n<p>\n\t Over the short term, we are planning to purchase medical equipment for a speech therapy room, and starting from 2021, we will support the orphanage on a continuous basis.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/fd2/DD.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK supports the IX online school of the Federation of Anesthesiologists and Resuscitators of Russia (FAR)","date":"23.08.2020","desc":"","link":"/en/news/companynews/nanolek-supports-the-ix-online-school-of-the-federation-of-anesthesiologists-and-resuscitators-of-ru/","inner_date":"23.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On August 15, 2020, an online FAR school dedicated to COVID-19 intensive care practices was held. NANOLEK traditionally supported the event. Three out of five reports covered the topic: \"The role and place of extracorporeal treatment methods\".\n</p>\n<p>\n <b>B.V. Silaev, Deputy Chief Physician for Anesthesiology and Resuscitation at the State Clinical Hospital # 15 named after O. M. Filatov, Department of Health of the City of Moscow</b>, emphasized in his report the importance of timely extracorporeal interventions in patients with multiple organ failure caused by COVID-19. Dr. Silaev shared his experience in using \"Efferon CT\" and \"Efferon LPS\" columns. All procedures were performed in the \"GD + hemoadsorption\" cascade mode, sorption columns were in use for not more than 12 hours. Indication for anti-cytokine hemoadsorption were signs of cytokine storm (at PCT<0.5), and for LPS-selective hemoadsorption – diagnosed gram negative sepsis.\n</p>\n<p>\n <b>S.V. Masolitin, an anesthesiologist-resuscitator</b>, represented the team of contributors on behalf of the State Clinical Hospital # 1 named after N.I. Pirogov, Department of Health of the City of Moscow. Is speech he elaborated on details of pathogenetic reasons for the use of anti-cytokine hemoadsorption in COVID-19 and summarized the experience of using Efferon CT columns in 29 patients with MOF (multiple organ failure) he managed to gather at his department. Early use of Efferon CT could stop progression of MOF, increase the oxygenation index, reduce the concentration of Il-6, and CRP. Dr. Masolitin made specific mention of the protective function of Efferon CT columns and emphasized that none of the self-breathing patients undergoing extracorporeal detoxification were subsequently transferred to a ventilator.\n</p>\n<p>\n\t A report delivered by <b>S.R. Gurbanova, transfusiologist of the Department of extracorporeal treatment and detoxification practices at the National Medical Research Center of Obstetrics, Gynecology and Perinatology named after academician V.I. Kulakov</b>, sparked the most lively discussion among more than 1,600 participants of the online school. Dr. Gurbanova told about several complex clinical cases that involved a series of intensive extracorporeal haemocorrection procedures. Dr. Gurbanova expressly indicated the unique properties of Efferon LPS columns, which selectively affect two heterogeneous types of therapeutic targets at the same time (LPS and cytokines), and noted the contribution of these properties to the therapy outcome.\n</p>\n<p>\n\t We would like to thank all participants of the event for their interest and attention devoted to the topic and questions asked.\n</p>\n<p>\n\t Please do not hesitate to send your questions and inquiries to: <a href=\"mailto:efferon@nanolek.ru\"><b>efferon@nanolek.ru</b></a>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/064/FAR.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK - a partner of the Vth ALL-Russian GMP conference","date":"20.08.2020","desc":"","link":"/en/news/companynews/nanolek-a-partner-of-the-vth-all-russian-gmp-conference/","inner_date":"20.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Headline - focus of anniversary conference: \"Common GxP rules — quality for the sake of health\".<br>\n <br>\n\t If you like to learn directly from professional experts and get to know all the rules governing the quality of development, production and further circulation of drugs, don't be late to register today, without waiting for tomorrow.<br>\n <br>\n\t Please note that the conference will be held online on following days: September 30-October 1, 2020, enjoy free participation during the event!<br>\n <br>\n\t NANOLEK supports the conference as a partner since the biopharmaceutical production complex of NANOLEK located in the Kirov region operates in line with GMP standards.<br>\n <br>\n\t The conference will be powered by the Ministry of Industry and Trade of the Russian Federation and the State Institute of Drugs and Good Practices.<br>\n <br>\n\t Register on the organizer's website by clicking on the \"Source\" button.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/03f/GMP-sayt.jpg"},{"tag":"COMPANY NEWS","title":"One Year Since NANOLEK Left the List of RUSNANO Portfolio Companies","date":"14.08.2020","desc":"","link":"/en/news/companynews/one-year-since-nanolek-left-the-list-of-rusnano-portfolio-companies/","inner_date":"14.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t One year ago, on August 14, 2019, Nanolek LLC left the RUSNANO portfolio companies' list.\n</p>\n<p>\n\t For the period from 2011 to 2014, RUSNANO invested 1.28 billion roubles in NANOLEK. The yield at the time of the exit reached 8.6%.\n</p>\n<p>\n\t Its independent year, part of which fell on a tough period of the pandemic turned out to be very productive for NANOLEK.\n</p>\n<p>\n\t Let us summarize some data:\n</p>\n<p>\n\t · In the autumn of 2019, NANOLEK began exporting its medicines to the foreign markets. The Company has registered three international generic medicines in Azerbaijan: antiallergic desloratadine Nalorius; also, Ramipril and Nebivolol, which are used for the treatment of cardiovascular diseases. The Company plans to join the state purchases of Uzbekistan and Belarus.\n</p>\n<p>\n\t · In October 2019, NANOLEK, together with Janssen, has launched a project to localize the production of Darzalex (daratumumab) in Russia, which is used in the treatment of multiple myeloma. It is the first human anti-CD38 monoclonal antibody approved for this type of disease.\n</p>\n<p>\n\t · In October 2019, NANOLEK became one of the founders and a member of the Biopolis Research and Educational Centre (REC) in Kirov Region. The purpose of the REC creation is to develop the biopharmaceutical industry in the region and the domestic pharmaceutical market. The other members of the association were the NRC Kurchatov Institute and the Federal State Budgetary Scientific Institution FNTSIRIP named after M.P.Chumakov of the RAS.\n</p>\n<p>\n\t At the end of 2019, the Company's revenue increased by 60% and reached 7.5 billion roubles compared to 2018. The volume of the Company's investments amounted to more than 500 million roubles. Profit reached 596 million. The Company transferred 100 million roubles as tax contributions to the budget of Kirov Region.\n</p>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b> \"I am thankful to our entire team for their enthusiasm to work towards results, develop new directions, and generate ideas. This period was difficult, but we are moving at an excellent pace, following the developed and approved strategy. Important agreements were signed, and on strategic partnerships, we entered new stages of cooperation in vaccine localization. I am certain that the financial results in 2020 will once again prove that the Company is on the right track.\"\n\t</p>\n</blockquote>\n<p>\n\t · In 2020, the NANOLEK site in Kirov Region was included in the federal list of backbone industries.\n</p>\n<p>\n\t · In March 2020, NANOLEK concluded a strategic partnership agreement with the Efferon Company to bring to the market medical devices that can be used, among other things, in the treatment of acute respiratory infection caused by SARS-CoV-2 (COVID-19). The companies donated medical devices developed by them to the city hospital in Kommunarka and the Moscow State University Medical Centre to treat severe complications caused by coronavirus.\n</p>\n<blockquote>\n\t<p>\n <b>Anatoly Valetov, Head of the Moscow Innovation Cluster Foundation: </b>\"This year, NANOLEK became a member of the cluster. This opened new opportunities for the development and creation of cooperative projects in the field of biomedicine. The symbiosis of proactivity and innovation always entails a rapid breakthrough, demonstrated in the partnership with another member of the cluster - Efferon Company. With great interest, I watch the development of the project and the joint work of NANOLEK and Efferon. The companies are promoting smart technologies in the healthcare market and using them to fight the new coronavirus infection. Besides, representatives of NANOLEK take an active part as experts in the Moscow accelerator Biomedtech track - they held an expert session, at which they shared advice on further development with the accelerator's participants. Thus, joining MIC, organizations expand their opportunities for cooperation with each other by implementing joint projects and joining the cluster's initiatives.\"\n\t</p>\n</blockquote>\n<p>\n\t · In April 2020, a little investment enterprise Invac filed for registration the first domestic inactivated vaccine against poliomyelitis based on Sabin strains using the technology developed by the FNCIRIP named after M.P.Chumakov of the RAS.\n</p>\n<p>\n\t · In May 2020, NANOLEK, in cooperation with NPK Kombiotech, launched a long-term project to produce an entirely domestic tetravalent vaccine, using patented technology, against human papilloma virus of four types (6, 11, 16, 18), which causes cervical cancer.\n</p>\n<p>\n\t · In the same month, Sanofi and NANOLEK bottled validation series as part of the full cycle production of the five-component paediatric combination vaccine (FCPCV) Pentaxim® in Russia. Sanofi is the vaccine developer. At the NANOLEK site in Kirov, a study of the stability of three validation series of the FCPCV began with the participation of Sanofi representatives.\n</p>\n<p>\n\t · In June 2020, NANOLEK has launched the first batch of hydroxychloroquine, which is included in the COVID-19 treatment regimens in the temporary guidelines provided by the Ministry of Health of the Russian Federation for the prevention, diagnosis, and treatment of the novel coronavirus infection.\n</p>\n<p>\n\t · In the same month, the Company received a registration certificate from the Ministry of Health of the Republic of Belarus for five years for the socially significant medicine named Hunterase. Green Cross is the manufacturer of the medication.\n</p>\n<blockquote>\n\t<p>\n\t\t “NANOLEK Company is only nine years old. It has been one year since it started operating independently, but it has already made some great successes. There are not many biopharmaceutical companies in Russia that are ready, and most importantly, able to interact within the framework of public-private partnerships. Our cooperation with NANOLEK is a powerful example of a successful collaboration between modern industrial production and a research and development enterprise. I am sure that our joint work in the field of modern domestic vaccines will contribute to import substitution, the expansion of the National Vaccination Schedule (NVS), and will create jobs for young workers, especially since we, together with NANOLEK, are members of the biotechnological and immunobiological scientific and educational centre BIOPOLIS, the decree on the creation of which was signed by the Governor of Kirov Region in October 2019\", s<b>aid General Director of FGBNU FNTSIRIP named after M.P.Chumakov of the RAS Aidar Ishmukhametov.</b>\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/6f9/rosnano-sayt.jpg"},{"tag":"COMPANY NEWS","title":"Nanolek Subsidiary IMMOLAB Becomes a Skolkovo Resident","date":"13.08.2020","desc":"","link":"/en/news/companynews/nanolek-subsidiary-immolab-becomes-a-skolkovo-resident-/","inner_date":"13.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Immolab, Nanolek, LLC subsidiary, received the rank of Skolkovo project member. With the support of the Innovation Centre, the company will be developing a vaccine against COVID-19.\n</p>\n<p>\n\t The official entry in the register was made on 12.08.2020.\n</p>\n<blockquote>\n\t<p>\n <b>Anton Pavlyukov, Director for Acceleration of the Biological and Medical Technologies Cluster of the Skolkovo Foundation:</b>\n\t</p>\n\t<p>\n\t\t \"New members of the cluster means new ideas, solutions, and experience exchange. Currently, the cluster pays particular attention to developments pointed at combating the COVID-19 pandemic. We often form projects in this field, when large industrial partners support our residents. We congratulate our colleagues and look forward to the soonest appearance of an innovative vaccine!\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t\"Immolab was created to develop innovative biotechnological medicinal preparations, primarily vaccines. The work is currently underway to create a vaccine against COVID-19 based on a unique recombinant protein molecule with a binary function. It is essential that the technological platform on which the development is taking place can be used to work on vaccines against influenza and other infections, where achieving long-term protection of the body is the most challenging goal. This platform will contribute a great deal to import substitution and maintain the country's epidemiological security,\" <b>as comments Timofey Nemankin, Deputy General Director of NANOLEK for Research and Development.</b>\n\t</p>\n</blockquote>\n<p>\n\t Currently, NANOLEK is a member of the Moscow Innovation Cluster (MIC), subordinate to the Moscow Department of Entrepreneurship and Innovative Development.\n</p>\n<p>\n\t The biopharmaceutical complex NANOLEK is located in Kirov Region. It is one of the members of the biotechnological and immunobiological scientific and educational centre BIOPOLIS. The decree to create it was signed by the Governor of Kirov Region Igor Vasiliev in October 2019.\n</p>\n<p>\n\t In 2020, Nanolek, LLC was included in the list of backbone enterprises of the Russian economy.\n</p>\n<p>\n\t The decision to include the organization in the list was made by the government commission to improve the sustainability of the Russian economy development. The industry list was published on the website of the Ministry of Industry and Trade of Russia on April 25, 2020.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a09/skolkovo-sayt.jpg"},{"tag":"COMPANY NEWS","title":"Mikhail Nekrasov, CEO of NANOLEK, participates in the discussion session \"Immunoprophylaxis during the pandemic\"","date":"12.08.2020","desc":"","link":"/en/news/companynews/mikhail-nekrasov-ceo-of-nanolek-participates-in-the-discussion-session-immunoprophylaxis-during-the-/","inner_date":"12.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On August 12, 2020, CEO of NANOLEK Mikhail Nekrasov visited the All-Russian Forum \"Health of the nation - the basis of Russia's prosperity\" and took part in the discussion session \"Immunoprophylaxis during the pandemic\" held under the auspices of the Ministry of Industry and Trade of Russia.\n</p>\n<p>\n\t The event was attended by: Nikolay Briko (Director of the Erisman Institute of Public Health, Head of Department of epidemiology and evidence-based medicine at I.M. Sechenov First Moscow State Medical University (MGMU), academician of the Russian Academy of Sciences (RAS), Leila Namazova-Baranova (President of the Union of pediatricians of Russia, academician of RAS), Dmitry Morozov (parliamentarian at the State Duma), Oksana Drapkina (Director of the National medical research center of preventive medicine, chief freelance therapist of the Ministry of Health of Russia), Andrey Prodeus (pediatrician, doctor of medical sciences, immunologist - allergist), Stanislav Gromov (Head of Operations Support Unit at the Department of development of pharmaceutical and medical industry of the Ministry of Trade and Industry of Russia).\n</p>\n<p>\n\t The main topics covered at the forum were: vaccination in Russia during the pandemic, scope and schedule of public procurement of vaccines for NCPP (National Calendar of Prophylactic Immunization), efforts taken by the immunobiological industry during the pandemic, the anti-vaccination movement as a global threat, the necessary measures to increase confidence in vaccination.\n</p>\n<p>\n\t The absolute majority of speakers showed their proactive position on immunization and responsible approach to their health. Through their example they prove that this is the most effective way to get protected against vaccine-preventable diseases. Misconceptions that exist around vaccination arise from a lack of information, as a consequence of distrust of the population, and due to other factors. One of the talking points expressed by Andrey Produes – \"mass immunization is necessary, but it must be a customized solution\" – may be taken as the basis of a public movement in support of immunization, which could provide clear answers to any questions related to this topic.\n</p>\n<blockquote>\n\t<p>\n <b>Mikhail Sergeevich Nekrasov, as a representative of the manufacturer of vaccines for the National Calendar of Prophylactic Immunization, commented:</b>\n\t</p>\n\t<p>\n\t\t \"The strategy pursued by NANOLEK is to produce and localize the production of high-quality modern vaccines as well as combined vaccines. Successful cooperation with leading global providers and Russian research institutes helps us produce world-class vaccines of the highest quality. I would like to emphasize that NANOLEK is the only company that produces inactivated polio vaccines (IPV) (\"Polimilex<sup>®</sup>\") as well as the only manufacturer of a five-component vaccine to prevent diphtheria, tetanus, whooping cough, polio and infections caused by Haemophilus influenzae type b (\"Pentaxime<sup>®</sup>\") in the Russian Federation.\n\t</p>\n\t<p>\n\t\t I would also like to mention one of the latest achievements of our production plant, which stayed opened during the pandemic:\n\t</p>\n\t<p>\n\t\t a new easy-to-use dosage form of IPV in monodose syringes; a phased transfer of technology to produce the finished dosage form of Pentaxime<sup>®</sup> vaccine is in its final stage, and stability checks of three industrial batches are now underway. NANOLEK reports on the availability of a vaccine produced at its own plant in the finished dosage form, starting from 2022. It is extremely vital that we initiate the vaccination of all children with 5-component vaccines in order to avoid a decrease in vaccine coverage and deterioration of the epidemiological situation.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f09/ZNOPR1.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK participates in the All-Russian forum \"Health of the nation - the basis of Russia's prosperity\" (ZNOPR)","date":"11.08.2020","desc":"","link":"/en/news/companynews/nanolek-participates-in-the-all-russian-forum-health-of-the-nation-the-basis-of-russia-s-prosperity-/","inner_date":"11.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Today, on August 11, 2020, the All-Russian forum \"Health of the nation - the basis of Russia's prosperity\" was kicked off at the Gostiny Dvor exhibition complex (4 Ilinka street). The forum will run until August 13.<br>\n <br>\n\t NANOLEK presents a new product in its portfolio – Efferon hemosorption columns, you can take a look at them at the joint booth of the Ministry of Industry and Trade. They have been successfully used for extracorporeal blood purification, and can also be used for effective treatment of complications from COVID-19.<br>\n <br>\n\t The schedule of the forum is expected to be eventful. Focus: protecting and promoting the health of our compatriots against the background of new challenges (relevant as never before!). ZNOPR forum is an annual event of the All-Russian public organization \"Nation's health league\" and the Ministry of Health of the Russian Federation.<br>\n <br>\n\t The forum will host a business program, the exhibition \"Health for everyone\" to showcase the latest practices and solutions in healthcare.<br>\n <br>\n\t The first day of the forum was attended by representatives of official agencies - Sergey Tsyb (First Deputy Minister of Industry and Trade of the Russian Federation), Igor Kagramanyan (First Deputy Minister of Health of the Russian Federation), Alexey Alyokhin (Director of Pharmaceutical and Medical Industry Development Department at the Ministry of Industry and Trade of the Russian Federation), etc.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/863/znopr.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK - a Nominee of the Second Stage of the Projects Selection for the Priority-2.0 National Award","date":"05.08.2020","desc":"","link":"/en/news/companynews/nanolek-a-nominee-of-the-second-stage-of-the-projects-selection-for-the-priority-2-0-national-award-/","inner_date":"05.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK was nominated for the second stage of project selection for the Priority-2.0 National Award, dedicated to the practical application of advanced technologies.\n</p>\n<p>\n\t The award organizers identified a new category called Overcoming, which can include innovative products, technological solutions, and new efficient technologies in the battle against the COVID-19 pandemic. NANOLEK passed the expert council's selection in the nomination with the Efferon hemosorption columns, which have already proven their effectiveness (the columns have been successfully used in medical institutions in many cities of Russia).\n</p>\n<p>\n\t Consequently, NANOLEK has been nominated in three categories for the Priority-2.0 Award in 2020:\n</p>\n<p>\n\t · Efferon Hemosorption columns (the Pharmaceuticals and Microbiological Industry Nomination);\n</p>\n<p>\n\t · Hunterase medicine (the Pharmaceuticals and Microbiological Industry Nomination);\n</p>\n<p>\n\t · Efferon Hemosorption columns (the Overcoming Special Nomination).\n</p>\n<p>\n\t The jury's final voting and the selection of the Priority Award winners, as well as the grand award ceremony, will take place in the second half of October 2020 in Moscow.\n</p>\n<p>\n\t Participation in the Priority Award has an impact on developing high-tech products and strengthening the position of domestic commodities in Russian and international markets. The award is a socially meaningful event and is widely supported by the leading Russian media.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/6f1/Prioritet.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK, a member of the Association of pharmaceutical manufacturers of the Eurasian Economic Union, congratulates Stanislav Naumov on his appointment as Chairman of the Association's Board","date":"03.08.2020","desc":"","link":"/en/news/companynews/nanolek-a-member-of-the-association-of-pharmaceutical-manufacturers-of-the-eurasian-economic-union-c/","inner_date":"03.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Effective from August 3, 2020, Stanislav Naumov will take up a post of Chairman of the Board of the Association of pharmaceutical manufacturers of the Eurasian Economic Union (hereinafter referred to as Association) to replace Dmitry Chagin in this position.\n</p>\n<p>\n\t Currently, Stanislav heads the Eurasian Center for Integrated Research and Communications powered by RSPP (Russian Union of Industrialists and Entrepreneurs), the National chamber of entrepreneurs of the Republic of Kazakhstan, Confederation of industrialists and entrepreneurs of Belarus and Secretariat of the Business Council of the EEU and is expected to combines these jobs with his duties at the Association. Before joining the Association Mr. Naumov worked in the capacity of Government Liaison Manager at X5 Retail Group. In the period between 2008-2010, Stanislav held the position of Deputy Minister of Industry and Trade of the Russian Federation. In this capacity, he personally participated in the development and implementation of industry strategies in energy, industry and trade as well as programs for the development of single-industry cities, small and medium-sized businesses.\n</p>\n<p>\n\t The Association of pharmaceutical manufacturers of the Eurasian Economic Union was registered in 2012. It includes leading full-cycle pharmaceutical manufacturers: Pharmstandart PJSC, Biocad CJSC, GEROPHARM LLC, Nanolek LLC, NTFF Polisan, Active Component JSC, Generium JSC, HTC ChemRar, Nativita JV LLC, Karaganda pharmaceutical plant LLP.\n</p>\n<p>\n\t In his new position, Stanislav Naumov will represent the members of the Association to the outside world, support finding solutions to strategic tasks facing the members, enhance the reputation of the domestic pharmaceutical industry and the Association as a guarantor standing for guaranteed access to high-quality, safe and effective high-tech drugs and medical devices. Besides, Mr. Naumov will participate in the harmonization of the current legislation of the Russian Federation and the EEU countries to international standards and regulations with regard to the sovereign interests of Russia and the EEU.\n</p>\n<blockquote>\n\t<p>\n <b>Stanislav Naumov, Chairman of the Board of the Association of pharmaceutical manufacturers of the Eurasian Economic Union (APMEEU): </b>\"It is a great honor and responsibility for me to join the union of such strong companies. I consider it as a very important task to join our efforts in the EEU market, and I hope that my experience in this field will open up new opportunities for the Association and attract new participants. I also hope that our joint work will make the integration with the EEU member states as effective as possible, and be of benefit to the state, business and society.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b> \"On behalf of the NANOLEK team, I'm happy to welcome the appointment of Stanislav Naumov to the position of Chairman of the Board of the Association of pharmaceutical manufacturers of the Eurasian Economic Union (APMEEU). I'm sure that his activities at a new workplace will boost the development of the domestic pharmaceutical industry and strengthen its global positions. I wish him good luck and declare that NANOLEK is willing to continue taking an active part in the Association's work.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/14d/sayt.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is a partner of the Istobenskiy cucumber festival 2020","date":"01.08.2020","desc":"","link":"/en/news/companynews/nanolek-is-a-partner-of-the-istobenskiy-cucumber-festival-2020/","inner_date":"01.08.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On August 1, Istobensk located in Orichevsky district of the Kirov region hosted a traditional holiday \"Istobenskiy cucumber\" in an unusual online format. This year the event will be held for the 24th time in a row.\n</p>\n<blockquote>\n\t<p>\n\t\t \"Such holidays help preserve traditions for future generations, popularize the Kirov Oblast as a region attractive for tourism, business development and as a place where local residents can enjoy a pleasant time, many of whom work at our biomedical complex. Therefore, our company is happy to support the festival,\" <b>commented Mikhail Sergeevich Nekrasov, CEO of NANOLEK.</b>The Festival host, the cucumber Tsar Istoben, showed the audience the brightest moments from the Chronicles of the past years (since 1998), organized competitions with prizes from partners, made a tour through local production plants, held a mini-championship on cucumber crisp and the First tournament on cucumber fights, visited the Museum of history of Istobensk.\n\t</p>\n</blockquote>\n<p>\n\t Although the festival was held online, almost 84,000 users were able to \"visit\" it!\n</p>\n<p>\n\t And we invite you to the next, 25th anniversary of \"Istobenskiy cucumber\" scheduled to be held on the last Saturday of July 2021!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/ccf/ogurets.jpg"},{"tag":"COMPANY NEWS","title":"Pyotr Koltypin, Vice-President of Sberbank PJSC, Chairman of the Volga-Vyatka Bank of Sberbank, visited the NANOLEK biomedical complex","date":"29.07.2020","desc":"","link":"/en/news/companynews/pyotr-koltypin-vice-president-of-sberbank-pjsc-chairman-of-the-volga-vyatka-bank-of-sberbank-visited/","inner_date":"29.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Pyotr Koltypin estimated the scale of production – a tour through the plant was personally conducted by Vladimir Khristenko, President of NANOLEK, and Danail Donchev, Director of BMC.<br>\n <br>\n\t In 2015, the Bank extended an investment loan to the company worth RUB 1.8 bln for a period of 7 years. All payments are made according to the schedule.<br>\n <br>\n\t Pyotr Nikolaevich visited our company for the first time and was pleased with what he saw.<br>\n\t NANOLEK is actively developing and expanding its production. At the end of the meeting, the parties discussed the prospects for further cooperation in lending to new investment projects. Besides, the parties shared their experience in business management amidst the ongoing coronavirus pandemic.<br>\n <br>\n\t Sberbank is a partner of NANOLEK in a wide range of banking products, including in a payroll program. This helps reduce the amount of paperwork: all information is transmitted electronically. Employees can always get paid on time, even if they are not in the workplace. We are planning to develop special programs for employees in the near future.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/93f/sber.jpg"},{"tag":"COMPANY NEWS","title":"Efferon columns shown to Veronika Skvortsova, head of the FMBA","date":"20.07.2020","desc":"","link":"/en/news/companynews/efferon-columns-shown-to-veronika-skvortsova-head-of-the-fmba-/","inner_date":"20.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On July 16, Skolkovo residents met Veronika Skvortsova, head of the Federal medical and biological agency (FMBA) of Russia. Six CEOs of biomedical companies presented their products to the head of the FMBA and discussed the prospects for implementing the developed solutions at the clinics of the Agency, conducting clinical trials as well as opportunities for contract development of solutions to meet the needs of the FMBA.\n</p>\n<p>\n\t Dmitry Romashin, Development Director at Efferon, showcased a similarly-named device for extracorporeal blood purification. Veronika Skvortsova said that FMBA is willing to examine the possibility of conducting clinical trials for extracorporeal blood purification devices: \"Given that toxicology and a large pool of hematology and transfusiology institutions are part of the FMBA of Russia, the proposed method may turn out to be very popular for a wide range of tasks. In particular, there is potential for using it in the treatment of COVID-19, but this naturally requires detailed research.\"\n</p>\n<blockquote>\n\t<p>\n <b>Veronika Skvortsova, head of the Federal medical and biological agency of Russia: </b>\"The Agency is represented by a wide network of institutions from different fields - ranging from basic science to high-tech applied medicine. By using this database and with the support of Skolkovo residents, we will be able to implement many projects conductive to develop domestic medicine.\"\n\t</p>\n</blockquote>\n<p>\n\t In spring 2020, Nanolek and Efferon entered into a strategic partnership targeted at vigorous roll-out of sorption columns to market. The Efferon LPS and Efferon CT columns are currently successfully used in a number of clinics in Moscow, St. Petersburg, Rostov-on-Don, Nizhny Novgorod, Surgut and other cities across the Russian Federation in the treatment of sepsis, bacterial-viral pneumonia, acute respiratory distress syndrome (ARDS) and the cytokine storm.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/2e0/VERONIKA-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Renewed market authorization for Nebivolol-NANOLEK","date":"17.07.2020","desc":"","link":"/en/news/companynews/renewed-market-authorization-for-nebivolol-nanolek/","inner_date":"17.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK was granted an extension of the market authorization for Nebivolol-NANOLEK. The corresponding entry LP-003049 was made in the State register of medicines.\n</p>\n<p>\n\t The drug has been manufactured at the NANOLEK biomecial complex in the Kirov region since 2015. The plant produces an average of 80,000 packages per year.\n</p>\n<p>\n\t Nebivolol-NANOLEK is used to treat arterial hypertension, coronary heart disease, angina of effort.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/40d/nebivolol-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Employees Joined the Certification Committee of Vyatka State University","date":"15.07.2020","desc":"","link":"/en/news/companynews/nanolek-employees-joined-the-certification-committee-of-vyatka-state-university/","inner_date":"15.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK and Vyatka State University have had a long-term partnership relation. Our company organizes the Doors Open Days and excursions to the enterprise for students who are involved in internships at BMC. A vivid illustration of the fruitful interaction is that 212 NANOLEK employees are real graduates of Vyatka State University, which is almost every third employee!\n</p>\n<p>\n\t Our company also attracts university professors to train employees, develop and implement a VR training project, etc.\n</p>\n<p>\n\t A unique tradition has been NANOLEK employees' presence in the examination committee for the protection of theses of graduates of Vyatka State University. This year, such an important role went to А. Grigorieva, A. Konkova, M. Sapozhnikov, O. Borovikova, I. Sorokina, M. Shuklina, M. Momotyuk.\n</p>\n<p>\n\t A total of 54 graduates were heard: Masters in Pharmaceutical Biotechnology and Microbiology and Virology, Bachelors in Pharmaceutical Biotechnology, Microbiology, and Chemistry.\n</p>\n<p>\n\t At the same time, six graduate students and one bachelor undergraduate are already working at NANOLEK.\n</p>\n<p>\n\t After defending the theses of the \"Pharmaceutical Biotechnology\" direction, the selection department employees received ten resumes from graduates. As regards one of them, a decision is already being made on employment at the chemical analytical laboratory of BMC NANOLEK.\n</p>\n<p>\n\t We thank Vyatka State University and, personally, its Vice-Rector for Science and Innovation - Sergey Litvinets - for the trust, and we look forward to continued productive cooperation!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d41/vyatgu-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Sums up Participation in GxP Summit","date":"13.07.2020","desc":"","link":"/en/news/companynews/nanolek-sums-up-participation-in-gxp-summit/","inner_date":"13.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t For the second year around, NANOLEK has become a partner of the GxP Summit.\n</p>\n<p>\n\t This is an excellent opportunity to tell young biotechnology professionals about our pharmaceutical company, which is almost the youngest in the world. To acquaint them with the achievements, whose number is quite significant already, and with the prospects of growth and improvement.\n</p>\n<p>\n\t NANOLEK is one of the leaders in the Russian Federation's paediatric vaccine market; it has unique experience in technology transfer, production, and commercialization of vaccines. Meanwhile, our corporate values, such as quality, openness, efficiency, partnership, and teamwork, are close to the new generation.\n</p>\n<p>\n\t This year, more than 720 participants attended the Summit from 87 universities, 61 cities of Russia, and 22 foreign countries.\n</p>\n<p>\n\t As a result, we received applications from 15 candidates to undergo an internship or try to catch the proposed vacancies. Do not doubt! All CVs will be carefully studied, and everyone will receive some feedback.\n</p>\n<p>\n\t If someone has not had time to apply, you can get familiarized with our vacancies.\n</p>\n<p>\n\t Join the NANOLEK team!\n</p>\n<p>\n\t See you at the 5th GxP-Summit-2021 in St. Petersburg, which will be anniversary!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/8b8/gxp-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Marina Mazurevskaya, Deputy General Director for Legal Issues and Work with Government Agencies Speaks at GxP Summit","date":"09.07.2020","desc":"","link":"/en/news/companynews/marina-mazurevskaya-deputy-general-director-for-legal-issues-and-work-with-government-agencies-speak/","inner_date":"09.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t July 9, as part of the GxP Summit, \"Choosing the Best. Time Forward,\" a Business Navigator was held. This is a kind of online compass in the world of pharma professionals. Participation in the navigator is an opportunity for senior students to qualify for an internship at a modern pharmaceutical company, and for holders of diplomas to start their career.\n</p>\n<blockquote>\n\t<p>\n <b>Marina Mazurevskaya, Deputy General Director for Legal Issues and Work with Government Agencies,</b> spoke about how actively NANOLEK grows and develops, what career opportunities it offers for employees: \"At work, we spend most of our lives, so it is crucial what the first job in life will be. Once choosing its path in pharmaceuticals, our entire team is responsible for the life and health of people who need our medications every day. We believe that our people are a real team. If you want to join a club of professionals, develop together with NANOLEK, grow, and gain new experience, we are waiting for you as an intern or a full member of our team.\n\t</p>\n</blockquote>\n<p>\n\t NANOLEK is not a soulless production line; first of all, it is PEOPLE, their actions, labour, and achievements. NANOLEK today is more than 700 employees, 35% are specialists in biotechnology, and 80% of top managers have two or more higher educations, including international ones, 60% have academic degrees. Our corporate values: quality, openness, efficiency, partnership, and the team.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/287/marina-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Supports the 8th Online FAR School","date":"06.07.2020","desc":"","link":"/en/news/companynews/nanolek-supports-the-8th-online-far-school-/","inner_date":"06.07.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t An online school of Anesthetists and Resuscitators Federation (PAR) was held on July 4, 2020, in the form of a training seminar. Practitioners from the medical community dedicated their reports to infectious diseases: COVID-19, sepsis, and nosocomial pneumonia.\n</p>\n<p>\n\t Although the pandemic spread across the globe yesterday a few months ago, we can observe positive statistics on the number of recovered. Yet, medicine is faced with a poorly studied aggressive virus. The webinar participants shared their gained expertise - this is what is the primary value when, in one place, medical workers can hear colleagues' experience, analyze it, and implement it in their work.\n</p>\n<p>\n\t The first speaker was V.V. Kulabukhov, Leading Researcher of GBUZ Research Institute of Ambulance, named after N.V. Sklifosovsky, Ph.D., docent. As you know, one of the hardest complications from the current COVID-19 is sepsis. Vladimir Vitalyevich spoke about present problems of sepsis, considered ways to solve this problem, raised epidemiology issues in general, as well as the questions of diagnosis and treatment. He also offered specific steps to combat sepsis for the medical community.\n</p>\n<p>\n\t One of the definitions of sepsis reads: sepsis is a pathological process based on the body's reaction in the form of systemic inflammation to an infection of different nature (bacterial, viral, fungal) in combination with acute signs of organ dysfunction or evidence of microbial dissemination.\n</p>\n<p>\n\t According to statistics Global Sepsis Alliance sepsis prevalence in the world is 30 million cases a year, about 6 million people die annually. However, only in 2017, did the WHO Assembly in Geneva recognize sepsis as a global problem.\n</p>\n<p>\n\t In his report, Vladimir Vitalyevich, in detail, shared his experience in the fight against sepsis. He also gave an example of a review of applied solutions for extracorporeal blood purification. He highlighted a unique bimodal sorption mechanism of Efferon-LPS. This column makes it possible to fight sepsis of the alleged gram-negative etiology, septic shock, critical endotoxemia, and ischemia syndrome-reperfusion.\n</p>\n<p>\n\t Since March 2020, NANOLEK has been actively engaged in sorption techniques in Russia and presents unique Russian solutions Efferon-LPS and Efferon-CT. The columns' production has been based on MSU Science Park and Cluster of Biomedical Technologies of the Skolkovo Foundation. \n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/5f7/sayt.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK expands its product line. Market authorizations for test kits were obtained","date":"26.06.2020","desc":"","link":"/en/news/companynews/nanolek-expands-its-product-line-market-authorizations-for-test-kits-were-obtained/","inner_date":"26.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK was awarded market authorizations for test kits to determine IgM and IgG antibodies against SARS-CoV-2 antigen in blood serum. Records RZN 2020/10959 (IgG) and RZN 2020/10963 (IgM) were included in the register on the website of Roszdravnadzor. These are the first market authorizations of NANOLEK for medical devices.\n</p>\n<p>\n\t Diagnostic test kits help determine your immune response to COVID-19 using ELISA method (biomaterial: blood). The presence of a minimum reference quantity of IgM antibodies may point to the onset and acute phase of the disease. The presence of IgG antibodies indicates the start of production of antibodies in blood against COVID-19 and a past disease that was asymptomatic or occurred with mild symptoms (similar to ARVI).\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk, Executive Director of NANOLEK:</b>\n\t</p>\n\t<p>\n\t\t \"Not so long ago the whole world and our country started returning slowly to normal life and usual rhythm. However, the media often publishes data and facts about asymptomatic transmission of COVID-19, people want to know information, and therefore it is important and necessary to pass antibody tests. We stay always in touch with our regional representatives in various regions of Russia and are well aware of their needs. In particular, we have received many times requests for diagnostic test kits. Therefore, it was decided to supply such systems to meet the demand in market in order to diagnose COVID-19, including in the Russian regions. There are signs that the pandemic is on the decline, but there is a great need for high-quality diagnostic and rapid test systems which we can use to quickly find out the presence or absence of IgG and IgM antibodies.\"\n\t</p>\n</blockquote>\n<p>\n\t \n</p>\n<h3>About NANOLEK</h3>\nNANOLEK\nis a modern fast-evolving Russian biopharmaceutical company with its own\nhigh-tech complete cycle production compliant with GMP and ISO standards.\nNANOLEK specialises in the production of import-substituting and innovative\npharmaceuticals, both in-house developed and invented with the help of\ninternational partners, focusing on the prevention and treatment of socially\nsignificant diseases. The company has unique experience in the area of transfer\nof technologies as part of partnership with the leading international\npharmaceutical companies (Merck, Sanofi, Novartis, Egis, Celltrion,\nRiemser, etc.). Nanolek LLC won the \"Platinum ounce\" contest in the\n\"Vector of the year\" nomination, \"Project of the year. Business\nproject\" subnomination, took the first place in the \"Fast-growing\nlarge companies\" category of the \"TECHUSPECH\" 2019 ranking,\nbesides the company participated in the priority project of the Ministry of\neconomic development of Russia \"Support for private high-tech leading\ncompanies\" (\"National champions\") in 2017\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f57/test-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK's Employees - Vadim Kalinichenko (Chief of Medical Department) and Daria Neverova (Chief of Registration Department) – attended the EAEU PHARMA WEEK","date":"19.06.2020","desc":"","link":"/en/news/companynews/nanolek-s-employees-vadim-kalinichenko-chief-of-medical-department-and-daria-neverova-chief-of-regis/","inner_date":"19.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Despite the summer heat and restrictive measures, business activity goes on! Especially when it comes to the industry's largest online event - the EAEU PHARMA WEEK, which is taking place on these days, June 17-19. This extraordinary event can't be missed because the organizers have prepared a highly topical program, an immersion course for pharmaceutical professionals.\n</p>\n<p>\n\t Many expert communities have already discussed what changes in life the coronavirus brought about. What lessons have we learned and how to live in a changed world? Today, it is time to expand horizons and plan for the future — headline forum topics: clinical trials in the EAEU, pharmacovigilance, and registration of medicines.\n</p>\n<p>\n\t Over 50 speakers, 300 participants in just three days, examined questions about the effect of coronavirus on clinical trials, the quality of remote monitoring and data obtained during the pandemic, and whether legislative changes are needed to conduct clinical trials. In addition to the remote work format, we also faced for the first time the need for accelerated medication development procedures, remote communication with regulating authorities as well as a shortage of medicines (restrictive measures had an effect here when imported raw materials for production cannot cross borders).\n</p>\n<p>\n\t We thank the organizers of the conference for the excellent reports delivered by the speakers and the opportunity to get information first hand. Undoubtedly, the world will never be the same as before. It is essential to exchange experiences, opinions, and best practices in a timely manner to jointly minimize the consequences of the processes that we are witnessing during the pandemic.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/999/4-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Yulia Deeva, Director for Corporate Communications at NANOLEK, a participant in the event of the Russian Managers Association \"Contours of Managerial Professions in a New Reality\"","date":"18.06.2020","desc":"","link":"/en/news/companynews/yulia-deeva-director-for-corporate-communications-at-nanolek-a-participant-in-the-event-of-the-russi/","inner_date":"18.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The strategic session was held on June 17 in the already traditional online format. Participants in the TOP-1000 Russian Managers Rating of different years were invited to take part. Specialists in HR, GR, PR, as well as lawyers, development, and promotion directors (from Unilever, Severstal, KFC, Coca-Cola, and Krasnaya Polyana) discussed how business development pathways changed. What threats exist? Are there any windows of opportunity out there?\n</p>\n<p>\n\t The colleagues were invited to discuss and enhance the following trends:\n</p>\n<p>\n\t - strengthening and expanding the role of the government, including control over private life;\n</p>\n<p>\n\t - a sharp decline in large-scale investments in prospective projects;\n</p>\n<p>\n\t - the shift in consumer preferences and habits towards more comprehensive rationality and pragmatism;\n</p>\n<p>\n\t - transfer to remote employment and a decrease in the importance of having a workspace in an office;\n</p>\n<p>\n\t - increasing the requirements for the competencies of employees, including the need to perform related functional responsibilities.\n</p>\n<p>\n\t During the discussion, some new additions appeared:\n</p>\n<p>\n\t - the trend of collaboration, both within different areas of the business, and between business and government agencies;\n</p>\n<p>\n\t - a change in the paradigm of interaction with different generations (various tasks need to be set, involved, a significant gap in the penetration of technology);\n</p>\n<p>\n\t - regional imbalance (this is acutely felt even not in geography but in terms of profit/income level, the difference in opportunities);\n</p>\n<p>\n\t - focus on mental health and psychological support.\n</p>\n<blockquote>\n\t<p>\n <b>Yulia Deeva:</b> \"Over the time of self-isolation, we noted that the demand for charity events has increased. People are willing to help those who are in much worse circumstances. I would also like to speak about working with the media. Often in the pursuit of click bait negative, panic moods are created that adversely affect the entire information background, and fact-checking also suffer.\"\n\t</p>\n</blockquote>\n<p>\n\t The research results will be presented in detail at the forum “The Future of Management Professions” this fall.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/479/yud-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK was given a market authorization by the Ministry of Health of the Republic of Belarus for the socially significant drug “Hunterase“","date":"17.06.2020","desc":"","link":"/en/news/companynews/nanolek-was-given-a-market-authorization-by-the-ministry-of-health-of-the-republic-of-belarus-for-th/","inner_date":"17.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK was given a market authorization by the Ministry of Health of the Republic of Belarus for the socially significant drug “Hunterase“ (Idursulfase beta) used in the treatment of the rare orphan disease Mucopolysaccharidosis type II. The drug is produced by Green Cross (Republic of Korea). At present, about 8 people in Belarus have been diagnosed with this disease.\n</p>\n<p>\n\t The market authorization is issued for a period of 5 years.\n</p>\n<p>\n\t Belarus became the third country where NANOLEK received a market authorization for this drug.\n</p>\n<p>\n\t<br>\n</p>\nMarket authorizations are also issued in Russia and\nKazakhstan.\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/9c9/x-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"General Director of NANOLEK - Mikhail Nekrasov - Takes Part in the ADVANTIX PHARMA VIRTUAL PLATFORM Virtual Farm Marathon","date":"10.06.2020","desc":"","link":"/en/news/companynews/general-director-of-nanolek-mikhail-nekrasov-takes-part-in-the-advantix-pharma-virtual-platform-virt/","inner_date":"10.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Mikhail Nekrasov, General Director of NANOLEK, took part in the virtual session “Priorities of the Russian Pharmaceutical Sector during the Global Pandemic.” The event was held using the Advantix Pharma Virtual Platform.\n</p>\n<p>\n <br>\n\t The organizers brought together the top managers and representatives of regulatory bodies to discuss Russian pharmaceuticals during the global pandemic. This is because pharmaceutical companies bear a great responsibility in this situation. What challenges did the industry face? What adjustments were needed to be made in the Russian healthcare system? Is it possible to organize the delivery of necessary medicines for their uninterrupted supply? How the priorities and directions of the Pharma-2030 program will change due to the global coronavirus pandemic? These, as well as many other questions, were raised during the discussion.<br>\n</p>\n<blockquote>\n\t<p>\n <b>Mikhail Nekrasov:</b> \"The Pharma-2030 program pays exceptional attention to immunology. Now we see an impetus for the development of the immunobiological industry. Around the world, a focus is being placed on research centers and production sites that can provide the population with protective equipment, including immunoprophylaxis vaccines. Yet you must remember that the development of a vaccine is one process. Still, its production is another, and it takes some time. For instance, it takes a year and a half to develop a polio vaccine. To release a sufficient amount of vaccines in an emergency, extra capacity is needed. If a vaccine for coronavirus is developed this July, then the entire population will be vaccinated by the end of next year.\n\t</p>\n\t<p>\n\t\t The pandemic has taught us a lot. It is necessary to be well-prepared in order to provide our population with medications and vaccines uninterruptedly.\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/737/1-MS-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK becomes the nominee of the \"Priority 2.0\" national award","date":"08.06.2020","desc":"","link":"/en/news/companynews/nanolek-becomes-the-nominee-of-the-priority-2-0-national-award-/","inner_date":"08.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Organizing committee of the \"Priority 2.0\" National award which is given for effective use of advanced technologies announced the nominees for the first stage of the contest. More than a dozen companies from different Russian regions were shortlisted and submitted applications with innovative products and solutions in several nominations. In September, the Expert council and the nominees will continue fighting for the victory in the competition.\n</p>\n<p>\n\t The festive award ceremony will take place in Moscow in early October 2020.\n</p>\n<p>\n\t By summing up the first stage of nominees' selection, Vitaly Rasnitsyn, Chairman of the Organizing committee of the \"Priority\" National award, emphasized that this year almost all business activities of the contest are carried out online, including receipt of applications and interaction with participants, and online sessions on industry-related topics.\n</p>\n<p>\n\t Nanolek has also become a nominee for the first stage of the Priority 2020 award with two projects at the same time.\n</p>\n<p>\n\t Nanolek LLC: a drug to treat the Hunter syndrome and sales of an extracorporeal blood purification device. Nomination - \"Pharmaceutics and microbiological industry\".\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/80d/2-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Mikhail Nekrasov, General Director, NANOLEK, supports construction of a sports ground in the village of Ugor","date":"07.06.2020","desc":"","link":"/en/news/companynews/mikhail-nekrasov-general-director-nanolek-supports-construction-of-a-sports-ground-in-the-village-of/","inner_date":"07.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t In 2019, the state program Integrated Development of Rural Territories started being implemented.\n</p>\n<p>\n\t Mikhail Sergeevich Nekrasov, General Director of NANOLEK, took part in the development of the Improvement of Rural Territories division by providing sponsor support for the construction of the sports ground in the village of Ugor.\n</p>\n<p>\n\t It was opened on June 1, on the Children’s Day and became an important part of the Healthy Lifestyle for Everyone project.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/7e4/1-vot-etot-fayl.png"},{"tag":"COMPANY NEWS","title":"Yulia Deeva, Head of Сorporate Сommunications at NANOLEK, live on the Echo of Moscow radio, Kirov","date":"05.06.2020","desc":"","link":"/en/news/companynews/yulia-deeva-head-of-sorporate-sommunications-at-nanolek-live-on-the-echo-of-moscow-radio-kirov/","inner_date":"05.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Yulia took part in Daria Tangel's \"101 PR\" show. She shared with the audience the anti-crisis PR activities, told about the process of building external and in-house communications, whether each employee should hype up their company, evaluating the efforts of a particular PR department and the common mistakes made by PR experts.\n</p>\n<p>\n\t Some interesting quotes:\n</p>\n<blockquote>\n\t<p>\n\t\t \"Communications do not cease to exist during a crisis. Public relations is a constantly ongoing process and you can't just stop doing it.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"A single information policy and speaker map help companies navigate quickly enough in the information landscape. PR community must always stay alert for any type of crisis, which may be predictable or unpredictable. And nowadays we all find ourselves in a new information reality.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"Employees have the right to know what is happening to the company, especially in such challenging times. Similarly, employees must be loyal towards their company. To do this, you need to create comfortable and attractive terms of employment. In-house communications are communications with employees in various chats, social networks, and on the portal.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"The information landscape does not tolerate any vacuum, and if you choose not to comment on the event, someone else will do it for you.\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/9c0/3-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Wins the Platinum Ounce Award","date":"05.06.2020","desc":"","link":"/en/news/companynews/nanolek-wins-the-platinum-ounce-award/","inner_date":"05.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On June 4, the anniversary ceremony of the All-Russian Open Competition for Pharmaceutical Market Professionals - Platinum Ounce 2019 - was held in an online format. Platinum Ounce is one of the honored professional competitions of the Russian pharmaceutical market. This year, the contest celebrated its 20th anniversary.\n</p>\n<p>\n\t NANOLEK hit the shortlist and became a finalist in two nominations: \"Vector of the Year\" sub nomination \"Project of the Year\" Business Project (for the creation of a joint venture Invak with the Chumakov Scientific Center) and \"Deal of the Year\" (for exiting profile company - \"Rusnano\").\n</p>\n<p>\n\t NANOLEK became the winner in the nomination \"Vector of the Year\" sub nomination \"Project of the Year\" Business Project and received an award for the creation of a small investment enterpriseInvak with the Chumakov Scientific Center, which will produce a full-cycle vaccine for immunization of the population of the Russian Federation under the NVS. The first project of the SIE Invak became the production of an entirely domestic polio vaccine, which was submitted for registration in April 2020.\n</p>\n<p>\n\t The registration of the vaccine will make it possible to uninterruptedly provide citizens of the Russian Federation with a highly effective and safe vaccine, which is included in the list of the National Vaccination Schedule (NVS). The partnership of the Federal State Budgetary Institution for Health and Social Development named after M.P. Chumakov of the RAS and Nanolek LLC - a successful example of a public-private business to bring promising domestic developments to the market.\n</p>\n<blockquote>\n\t<p>\n <b>Maxim Stetsyuk, Executive Director of NANOLEK:</b>\n\t</p>\n\t<p>\n\t\t \"On behalf of NANOLEK, I thank the jury and everyone who voted for the high appreciation of the activities of our company. We are pleased to receive the Platinum Ounce Award as a symbol of recognition of our team's merits. NANOLEK hit the list of backbone companies of the Ministry of Industry and Trade. Therefore, we did not stop our work even for a minute, even in these difficult conditions. SIE Invak may become a new model of a public-private partnership to market promising domestic developments. The project provides for the construction of additional production facilities as part of the biotechnological immunobiological research, and educational center's development in the Kirov Region named Biopolis. Both organizations are the participants thereof. I congratulate our company's staff for the next breakthrough in the history of modern pharmaceuticals and urge all companies to pay attention to talented young people, young scientists whom we, by our example, can motivate for discoveries!\"\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/9af/untsiya-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK provides charity support to regional medical institutions and patient organizations during the epidemic","date":"04.06.2020","desc":"","link":"/en/news/companynews/nanolek-provides-charity-support-to-regional-medical-institutions-and-patient-organizations-during-t/","inner_date":"04.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK has provided support to 16 medical centers in 8 regions of the Russian Federation. The company delivered medical masks, protective gloves, and disinfecting agents free of charge in order to build barriers preventing from the spread of SARS-CoV-2 among employees working with the state healthcare providers.\n</p>\n<blockquote>\n\t<p>\n <b>Maksim Stetsyuk, Executive Director of NANOLEK:</b>\n\t</p>\n\t<p>\n\t\t “For our company, protection of people’s health and lives is not mere words, but a mission. We live this idea and put it into life every day. The willingness to support physicians has emerged immediately after the official onset of the pandemic. NANOLEK positions itself as a socially active organization that supports physicians not only in the regions of its presence (its industrial complex is located in Kirov oblast and its head office is in Moscow), but also in other regions of Russia. The socially important program for the realization of charity support covers such regions as: Central Federal District, Northwest Federal District, Volga Federal District, South Federal District, etc.”\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Head of the medico-genetic department of the State Budgetary Healthcare Institution of Novosibirsk oblast State Clinical Hospital 1, Doctor of Medicine, professor Yulia Vladimirovna Maksimova:</b>\n\t</p>\n\t<p>\n\t\t “On behalf of the team of the Diagnostic Center of the State Budgetary Healthcare Institution of Novosibirsk oblast State Clinical Hospital 1, in particular on behalf of the medical staff of the Medico-genetic Department, I would like to convey sincere appreciation to the team of Nanolek LLC for the humanitarian aid provided as personal protective equipment and disinfecting solutions in times of hardest struggle against potentially severe acute respiratory infection caused by SARS-CoV-2.\n\t</p>\n\t<p>\n\t\t Considering the fact that the virus is transmitted through the air, during the pandemic of coronavirus infection COVID-19, physicians remain vulnerable without personal protection means and sufficient amounts of antiseptic and disinfecting agents.”\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Lyudmila Vasilyevna Goroshko, Head of medico-genetic consulting department of the Regional Clinical Consulting and Diagnostic Center of Stavropol Krai:</b>\n\t</p>\n\t<p>\n\t\t “On behalf of all employees of our Center, I would like to express our sincere gratitude to NANOLEK for the aid provided. In these hard times, personal protection means delivered came in handy and allowed our physicians to keep providing aid to patients suffering from inherited pathologies and other diseases and stay protected from the subtle and discrete enemy without suspending their activities. Our thanks to NANOLEK!”\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Employees of V.A. Almazov National Medical Research Center:</b>\n\t</p>\n\t<p>\n\t\t “In these tough times, when physicians often risk their lives in the background of a pandemic, working to save patients, any aid is important. We are sincerely grateful to NANOLEK for care, attention and concerned approach.”\n\t</p>\n</blockquote>\n<p>\n\t The donated item is considered as special-purpose receipts in line with the Civil Code of the Russian Federation and Federal Law 135-FZ dated 11.08.1995 ”On Charitable Activities and Charitable Organizations.”\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/689/Blago-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Releases Its First Batch of Hydroxychloroquine","date":"02.06.2020","desc":"","link":"/en/news/companynews/nanolek-releases-its-first-batch-of-hydroxychloroquine/","inner_date":"02.06.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK released the first batch of Hydroxychloroquine produced at its production site in the Kirov Region.\n</p>\n<p>\n\t Hydroxychloroquine has been included in the COVID-19 treatment regimen in temporary guidelines of the Russian Ministry of Health for the prevention, diagnosis, and treatment of new coronavirus infection.\n</p>\n<p>\n\t The first batch of this medicine has been sent to medical institutions.\n</p>\n<blockquote>\n\t<p>\n\t\t \"Our high-tech full-cycle production, according to GMP and ISO standards, located in the Kirov Region, allowed us to deploy the production of this drug within the shortest possible time. We have vast experience in the production of solid dosage forms (SDF). We hope that the medicine release will reduce the shortage and cover the need for this drug because there is still a need for patients with malaria and rheumatoid arthritis who have been treated with this medication for many years. Our company began the development of Hydroxychloroquine back in 2013, together with BIOCOM as a co-executor, under the state contract for the implementation of research and development work \"Development of Technology and Organization of the Production of Synthetic Vital and Essential Medicine - Hydroxychloroquine not produced by domestic manufacturers and not protected by patents of foreign companies on the territory of the Russian Federation; \"Code\" 1.1. Hydroxychloroquine 2013\", <b>said Mikhail Nekrasov, CEO of NANOLEK.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"The laboratory complex at BMС consists of several units: chemical-analytical, microbiological, biochemical, input control groups, finished product control, design, and control group and a monitoring group. The equipment of laboratories makes it possible to carry out quality control of any level of complexity. Currently, 123 specialists are working in the quality control department. All types of control have been passed following the data on the drug dossier; a positive conclusion was received, allowing the quality service to confirm the safety of the drug for release into circulation,\" <b>said Alexey Pavlov, Director of Quality Department, BMС NANOLEK.</b>\n\t</p>\n</blockquote>\n<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/063/gkhkh-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Takes Part in the ONLINE EVENT: PHARMA ADVANCE CONFERENCE","date":"30.05.2020","desc":"","link":"/en/news/companynews/nanolek-takes-part-in-the-online-event-pharma-advance-conference/","inner_date":"30.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Key players in the pharmaceutical business have come together to discuss current issues and exchange opinions gavel-to-gavel.\n</p>\n<p>\n\t The participants exchanged their views and thoughts on the work of the pharmaceutical industry in the new environment, discussed what legislative initiatives had emerged, and whether they would survive the pandemic, whether the approach to the development and research of new medications had changed.\n</p>\n<p>\n\t Maxim Stetsyuk, Executive Director of NANOLEK, took part in the Round Table Talk: \"PHARMACEUTICAL MARKET IN RUSSIA IN THE AGE OF UNCERTAINTY: HOW TO LIVE ETHNIC BUT PRACTICAL LIFE?\n</p>\n<p>\n\t He told how, in his opinion, the world would change after the coronavirus pandemic and what changes in legislation await the pharmaceutical business.\n</p>\n<p>\n\t Interesting quotes:\n</p>\n<p>\n\t \"Certainly, the crisis will change approaches in business. Even now, many are reconsidering their costs and managing to assess whether or not employees' transition to remote access was successful.\"\n</p>\n<p>\n\t \"In general, the pharmaceutical market has received an incentive for development, but each segment reacts differently. Pharma is a regulated industry, and some processes have accelerated, while the others slowed down.\"\n</p>\n<p>\n\t<br>\n</p>\n\"As regards legislative initiatives, we have room to develop the\nNational Preventive Vaccination Calendar (NPVC) and, following the example of\nmany countries, adopting their experience, switch to the use of combined\nvaccines that can reduce the injection burden on children. For example, one\nvaccine can protect against five infections at the same time.\"\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/c73/afhvf-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK and Sanofi Enter a New Stage of Localization of a Five-component Combined Pediatric Vaccine","date":"29.05.2020","desc":"","link":"/en/news/companynews/nanolek-and-sanofi-enter-a-new-stage-of-localization-of-a-five-component-combined-pediatric-vaccine/","inner_date":"29.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Companies Sanofi and NANOLEK announced a new stage in the development of a long-term partnership to localize the full-cycle production in Russia of a five-component combined pediatric vaccine developed by Sanofi, in particular, successful bottling of validation series.\n</p>\n<p>\n\t At the biomedical production complex of NANOLEK in Kirov, the stability of three validation series of a five-component combined pediatric vaccine is being studied with the participation of representatives of Sanofi. Under the Technology Transfer Agreement, during the established period, quality control will be carried out.\n</p>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b> \n\t</p>\n\t<p>\n\t\t\"We are happy that our partnership with Sanofi Pasteur has entered a new era. Multi-component vaccines are a modern and important instrument to combat vaccine-controlled infections. We hope that the new stage of localization - the full-cycle production of the finished dosage form will remove all barriers to the inclusion of the five-component combined pediatric vaccine in the National Calendar of Preventive Vaccinations for all children, and not just for risk groups. The pandemic has shown how acute the vaccination issue may be, and that we can all be at risk at any time.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Frederick Jumel, General Manager of Sanofi Pasteur Eurasia:</b>\n\t</p>\n\t<p>\n\t\t\"Over the last years, Sanofi Pasteur and Nanolek have contributed significantly to the fight against vaccine-controlled infections. Thanks to the mutual efforts, we have passed another essential step in the project to localize our five-component pediatric vaccine production, which means we are one step closer to our common goal: to protect all Russian children against dangerous infections. In the context of the challenges the world is facing today, issues of increasing vaccination coverage and effective disease control are stepping forward. Thanks to the implementation of our project, we can make a significant contribution to solving these problems\". \n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Nikolay Briko, Head of the Department of Epidemiology and Evidence-Based Medicine, First Moscow State Medical University named after I.M. Sechenov, M.D., an academician of the Russian Academy of Sciences, Professor, Honored Worker of Russian Science, chief freelance epidemiologist of the Ministry of Health of the Russian Federation: </b>\n\t</p>\n\t<p>\n\t\t\"I see great potential in collaboration between Sanofi and NANOLEK; it helps us to introduce advanced technologies for the production of vaccines in the Russian Federation. The product quality meets high international standards. And most importantly, in this case, we are talking about a combined vaccine. Combined vaccines can reduce the number of injections, especially for children in their first two years of life, as well as the costs of administering, storing, and trafficking medications throughout the multi-faceted supply chain.\"\n\t</p>\n</blockquote>\n<h3>\nAbout the Partnership Project of Sanofi and NANOLEK </h3>\n<p>\n\t NANOLEK and Sanofi are united by a common goal - the protection of Russian children against vaccine-controlled infections. In achieving this goal, Sanofi Pasteur and NANOLEK have already made a notable success.\n</p>\n<p>\n\t The cooperation agreement was signed in 2016. Since 2017, the vaccine has been successfully supplied as part of the National Calendar of Preventive Vaccinations. In 2019, a 2-year state contract was concluded for the first time (for 2019-2020) for the supply of vaccines to the NKPP. Under the agreement, NANOLEK entirely performed the obligations of the first year: the first phase of the delivery of a pediatric five-component combined vaccine was completed. In total, 3.5 million doses of the vaccine were produced and delivered in 2019 - this helped protect about 1 million children against five dangerous infections: tetanus, pertussis, diphtheria, poliomyelitis, and Haemophilus influenza type b.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/877/Validatsiya-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK has awarded its champions","date":"27.05.2020","desc":"","link":"/en/news/companynews/nanolek-congratulated-the-champions/","inner_date":"27.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Championship Program in the 1st quarter of 2020 became a unique tool for encouraging and motivating members of the NANOLEK team. In this challenging time of the pandemic, all employees continued to work: someone in remote access mode; production - in a usual way, but with increased labor protection measures. Many employees worked in an even more intense manner, sometimes at the limit of their capabilities. Therefore, the number of nominees was three times higher than usual.\n</p>\n<p>\n\t On May 27, at BMK NANOLEK, in Kirov, General Director Mikhail Nekrasov congratulated the Champions, and Executive Director Maxim Stetsyuk awarded the Moscow Champions.\n</p>\n<p>\n\t Congratulations to Maxim Bakin, Olga Valko, Denis Zapevalov, Julia Ivanova, and Aliya Khabibova!\n</p>\n<p>\n\t According to the corporate tradition, the champions received certificates, honorable distinctions, and branded gifts.\n</p>\n<p>\n\t Since the 2nd quarter of 2020, the program rules will be improved, which will give an even higher impulse for the development and motivation of the NANOLEK team!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e55/chempiony-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"CANCER Can Be Prevented: NANOLEK and Combiotech NPK Announce the Start of a Joint Project to Develop and Market First Fully Domestic Vaccine against Human Papillomavirus","date":"26.05.2020","desc":"","link":"/en/news/companynews/cancer-can-be-prevented-nanolek-and-combiotech-npk-announce-the-start-of-a-joint-project-to-develop-/","inner_date":"26.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The Russian biopharmaceutical company NANOLEK and the research and production company COMBIOTECH announced a long-term strategic partnership for the production, under the patented technology, of an entirely domestic 4-valent vaccine against human papillomavirus (HPV) of 4 types (6, 11, 16, 18) that cause cervical cancer, following the development strategy of the Russian pharmaceutical industry.\n</p>\n<p>\n\t It was found that cervical cancer (CC) in 66.2% is caused by HPV type 16 and 18, according to independent scientific publications.\n</p>\n<p>\n\t According to the World Health Organization, cervical cancer (CC) is only cancer that can be prevented by primary prevention - vaccination against HPV.\n</p>\n<p>\n\t In Russia, the economic damage fr om cervical cancer associated with HPV is about 50 billion rubles a year.\n</p>\n<p>\n\t The full-cycle production of this medication will be carried out by the NANOLEK facilities in the Kirov Region in strict compliance with GMP standards and technical requirements for the creation of such vaccines.\n</p>\n<p>\n\t Investments in the organization of the production of an entirely domestic vaccine against human papillomavirus (HPV) of 4 types (6, 11, 16, 18) will amount to about 1.8 billion rubles.\n</p>\n<p>\n\t The vaccine has high export potential. To date, the WHO is increasing procurement and predicting a deficit of vaccine supplies in the future, so the project also involves an export component (prequalification of the vaccines is being planned according to the WHO's requirements). Until 2027, the WHO prognosticates a vaccine deficiency of up to a third of the need. The WHO intends to expand vaccination age for multi-age cohort (MACs) introduction campaigns fr om 9-14 years old to 5-14 years old. Additional demand may create the introduction of vaccination for boys.\n</p>\n<blockquote>\n\t<p>\n <b>Ivan Borisov, President of Combiotech NPK, commented on the signing of the agreement: </b>\"I would like to emphasize that NANOLEK is a competent partner with great experience in vaccination. I am sure that our joint project has a great future and a good export potential. The HPV vaccine is relevant worldwide in the fight against cancer. The development and launch of entirely domestic production of HPV vaccines meet the instructions of the Russian President to ensure a full-cycle production of domestic vaccines in the Russian Federation. The planned time lim it to complete preclinical trials is mid-2020; meanwhile, clinical trials will continue until the end of 2022. At the end of 2023, it is planned to register and start production of the medicine\".\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b> \"Our joint project is a vivid illustration of the NANOLEK mission - to protect the lives and health of people by making the best technology available to everyone. To date, 91 countries in the world have included the HPV vaccine in their national vaccination calendars. I want to give a positive example of Moscow, wh ere vaccination against HPV is included in the Regional calendar of preventive vaccinations and is free of charge. We hope that this pattern will be followed throughout Russia, and the NKPP will be expanded, which will significantly reduce mortality from this disease\".\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"The human papillomavirus is extremely dangerous because it can cause cervical cancer. HPV vaccination significantly reduces this risk. The maximum effect of vaccination is achieved before contact with the infection. Therefore it is advisable to conduct it in adolescence. According to the Regional Preventive Vaccination Calendar, vaccination against HPV is free for girls aged 12–13,\" <b>noted the Chief of the Moscow Department of Health Alexey Khripunat</b> at the March 4th event dedicated to World HPV Day.\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n <b>Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation: </b>\"This investment project will make it possible to create new production facilities, high-tech jobs, to form production competencies for the introduction of unique industrial technology, an analog of which is currently missing in the Russian Federation. The initial production volume will be at least 2 million doses, with the subsequent increase in capacity for export projects. According to experts, 70% of the vaccination coverage of the target population in Russia will help preserve the health of many women\".\n\t</p>\n</blockquote>\n<p>\n\t About COMBIOTECH\n</p>\n<p>\n\t CombiotechScientific Production Company\" was founded in 1992 by a group of Russian scientists. The company's objective was to develop effective and safe vaccines for mass immunization of adults and children. Vaccine production by CombiotechNPK meets the current GMP requirements. The quality management system implemented at the enterprise is certified for compliance with the requirements of GOST R ISO 9001-2001 and GOST R 52249-2004. The scientific and production base created over the years allows Combiotech NPK CJSC to carry out constant scientific research independently and with the involvement of other specialized research and production enterprises. The following products represent the leading product portfolio: hepatitis B vaccine recombinant, combined vaccines BuboCoc (HebbDTP), and Bubo-M (HebbDS), HPV vaccine (at the stage of DPI).\n</p>\n<p>\n\t About NANOLEK\n</p>\n<p>\n\t NANOLEK is a modern fast-growing Russian biopharmaceutical company with its high-tech full-cycle production according to GMP and ISO standards, which specializes in the production of import-substituting and innovative medications, both of its own design and those created with the involvement of international partners, with a focus on prevention and treatment of socially significant diseases. The company has unique experience in technology transfer in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.). Nanolek LLC took first place in the category \"Fast-growing large companies\" TEKHUSPEKH -2019 ranking. The company was also a member of Minek's priority project \"Support for Private High-Tech Leading Companies\" (\"National Champions\") in 2017.\n</p>\n<p>\n\t Today, the company is one of the leaders in the production of pediatric vaccines in the Russian Federation. The diversified product portfolio of NANOLEK preparations is presented in the following therapeutic areas: vaccines, drugs for the treatment of HIV, cancer, etc.\n</p>\n<p>\n\t August 14, 2019, Nanolek LLC left the list of RUSNANO portfolio companies.\n</p>\n<p>\n\t \n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/634/Kombiotekh-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk, Executive Director of NANOLEK, a speaker at the online-conference The Economy of the Virus. Pharmaceutical Market at the Forefront","date":"21.05.2020","desc":"","link":"/en/news/companynews/maxim-stetsyuk-executive-director-of-nanolek-a-speaker-at-the-online-conference-the-economy-of-the-v/","inner_date":"21.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Today, on May 21, there was conducted online conference organized by the Kommersant Publishing House. Obviously, the spread of coronavirus has affected all areas of our lives and, to a greater extent, the pharmaceutical industry, subjected to its unique laws. Especially since the pharmaceutical industry is now literally at the forefront in the fight against the unfolding pandemic. The critical concern of the conference: is the industry ready for changed realities? What changes await it? What are government support measures needed? \n</p>\n<p>\n\t Representatives of departments, regulatory organizations, and business - the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade, the Association of Russian Pharmaceutical Manufacturers, etc participated in the conference.\n</p>\n<p>\n\t Maxim Stetsyuk, in his speech, outlined the situation from the perspective of a pharmaceutical manufacturer, reminding that vaccination is the most effective way to fight viruses and infections. During the pandemic, NANOLEK has been involved in the development of modern vaccines and medications that can help to cure coronavirus. But to prevent the disease in the future, it is necessary, way in advance, to prepare and understand what vaccines will be needed; hence, the National Calendar of Preventive Vaccinations needs to be developed now.\n</p>\n<p>\n\t<br>\n</p>\n<blockquote>\n\t \"Our industry faced some obstacles throughout the pandemic. For example, the localization issue has become exacerbated: we felt that we were dependent on substance manufacturers in China and India, not so much because of exchange rates, but because of closed borders under restrictions. It is essential to develop within the country the full cycle and development of own substances, as well as their availability in the market. It is necessary to create educational collaborations between research institutes and manufacturers to create appropriate modern medications,\" <b>commented Maxim Stetsyuk.</b>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/8ec/Posty-v-sotssetyakh-_-YArlyk.lnk.jpg"},{"tag":"COMPANY NEWS","title":"President of NANOLEK Vladimir Khristenko takes part in Science Bar Hopping","date":"18.05.2020","desc":"","link":"/en/news/companynews/president-of-nanolek-vladimir-khristenko-takes-part-in-science-bar-hopping/","inner_date":"18.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Science Bar Hopping is a science festival organized by the Foundation for Infrastructure and Educational Programs - FIOP (RUSNANO Group) and the media company \"Bumaga\" from Saint Petersburg.\n</p>\n<p>\n\t Vladimir gave an interview on a very important and interesting topic – how to produce vaccines. This is a unique chance to prise out the whole truth firsthand from a CEO of a pharmaceutical company.\n</p>\n<p>\n\t Some interesting quotes:\n</p>\n<blockquote>\n\t<p>\n\t\t \"It is widely accepted that one of the three main phenomena that influenced the growth of life expectancy in the XX century (along with clean water and eradication of hunger) is the widespread introduction of vaccination. This has helped to increase the average life expectancy of the world's population by 20-30 years.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"Vaccines protect us and our children from various infections. As a father of two small children, I will tell you honestly - we do all the necessary vaccinations, including the combined vaccines produced at our factory.\"\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"The obvious trend is to improve convenience and ease of use of vaccines: combination vaccines instead of monovalent vaccines. You can take just two (!) combined vaccines to get protected from ten infections at the same time (such as diphtheria, whooping cough, tetanus, hepatitis B, Hemophilus infection, polio, measles, rubella, mumps, chicken pox).\"\n\t</p>\n</blockquote>\n<p>\n\t \n</p>\n<p>\n <i>You can watch the recorded interview with Vladimir Khristenko in Russian by clicking on the \"Source\" button.</i>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/c00/Bar-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Results of Mandatory Audit of NANOLEK for 2019 Are Now Published","date":"18.05.2020","desc":"","link":"/en/news/companynews/results-of-mandatory-audit-of-nanolek-for-2019-are-now-published/","inner_date":"18.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t An Auditor's Report has been prepared by an independent auditor on the annual accounting (financial) statements of Nanolek LLC for 2019 «10» of April 2020, compiled by Crow RusauditLLC. The auditor made the opinion that the Accounting (financial) statements of Nanolek LLC are reliable and adequately reflect the financial results of operations and cash flows of Nanolek LLC.\n</p>\n<p>\n <b>Audited entity:</b>\n</p>\n<p>\n\t NANOLEK LLC\n</p>\n<p>\n\t TIN 7701917006, OGRN 1117746339369\n</p>\n<p>\n <b>Auditors:</b>\n</p>\n<p>\n\t CROW RUSAUDIT LLC\n</p>\n<p>\n\t TIN 7716044594, OGRN 1037700117949\n</p>\n<p>\n\t \n</p>\n<h3>\nFINANCIAL STATEMENTS</h3>\n<p>\n\t Reporting period: 01.01.2019 - 31.12.2019\n</p>\n<p>\n\t List of Documents:\n</p>\n<p>\n\t The balance sheet as of December 31, 2019, the Statement of Financial Results (January-December 2019), the Statement of Changes in Equity for January - December 2019, the Statement of Cash Flows for January - December 2019.\n</p>\n<p>\n\t \n</p>\n<h3>\nAUDIT RESULTS </h3>\n<p>\n\t Date of Conclusion: 10.04.2020\n</p>\n<p>\n\t Auditor's Opinion:\n</p>\n<p>\n\t The financial statements of Nanolek LLC reliably reflect the financial position of Nanolek LLC as of December 31, 2019, as well as the financial results of Nanolek LLC for 2019, and cash flows in 2019. The financial statements of Nanolek LLC have been compiled and maintained following the current accounting standards adopted in the Russian Federation.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f64/audit-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Supports the Russian Health Ministry's Children Health School","date":"15.05.2020","desc":"","link":"/en/news/companynews/nanolek-supports-the-russian-health-ministry-s-children-health-school/","inner_date":"15.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On May 14, 2020, the Children Health School, a new project launched by the Russian Health Ministry's National Medical and Research Center for Children's Health (federal state-owned autonomous institution), was held online.\n</p>\n<p>\n\t The advanced research based on the contemporary approach to the key pediatric problems underlies the School's curriculum. The target audience is pediatricians, allergologists and immunologists, dietologists, neurologists, neonatologists.\n</p>\n<p>\n\t NANOLEK supported the session held by Prof. Ludmila Mikhailovna Kuzankova, Ph.D., who covered the Hunter's Syndrome Diagnosis and Treatment in Children. Ludmila Mikhailovna dwelled on the difficulties with early diagnosis of this rare but severe genetic condition (Type II mucopolysaccharidosis), reviewed the clinical pattern and the multi-disciplinary treatment principles. The second report part presented by Tatiana Vladimirovna Podkletnova, Candidate in Medicine, was devoted to the enzyme substitution treatment of Type II mucopolysaccharidosis and included a clinical case of Idursulphase Beta (Hunterase) administration.\n</p>\n<p>\n\t NANOLEK has localized manufacturing of several socially significant drugs that did not use to be produced in Russia, in particular, the original drug of Idursulphase Beta, for Type II mucopolysaccharidosis treatment. The Federal Register of Patients with Life Threatening and Orphan Diseases contains data on 128 patients suffering from Type II mucopolysaccharidosis, as of January 2020, according to the Russian Health Ministry.\n</p>\n<p>\n\t Experts have already estimated that the use of original drug of Idursulphase Beta helps save almost RUB 800 million of federal budget funds as compared with the alternative treatment options.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d01/SHkola-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK joins the American Chamber of Commerce (AmCham Russia)","date":"12.05.2020","desc":"","link":"/en/news/companynews/nanolek-joins-the-american-chamber-of-commerce-amcham-russia/","inner_date":"12.05.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The American Chamber of Commerce (AmCham Russia) is one of the leading foreign business associations in Russia, which unites more than 500 major American, European and Russian companies.\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t \"For NANOLEK, membership in AmCham Russia is an important step in the reality that we are witnessing today. The world is changing, and we must all support each other, share experiences and ideas and be at the forefront of the global scientific and business agenda. This is exactly the strategy that can be implemented through the cooperation with representatives of the global community. The American Chamber of Commerce is the very platform that gives you the opportunity to share experience and implement joint initiatives with representatives of the leading global corporations,\" <b>commented Vladimir Khristenko, President of NANOLEK.</b>\n\t</p>\n</blockquote>\n<p>\n\t \n</p>\n<blockquote>\n\t<p>\n\t\t \"The American Chamber of Commerce in Russia (AmCham) welcomes the decision of NANOLEK, an innovative Russian company developing its business in such mainstream area as biopharmaceutics, to join our business community. Members of our Chamber in Russia are many world-class pharmaceutical providers worldwide. I'm sure that our entire pharmaceutical community will benefit from NANOLEK becoming a member of AmCham and through the establishment of new global partnerships this will boost business development inside NANOLEK,\" <b>said Alexis Rodzianko, President of the American Chamber of Commerce in Russia.</b>\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d74/AmCham-vot-etot-fayl.jpg"},{"tag":"COMPANY NEWS","title":"Danail Donchev is appointed Director of the NANOLEK biomedical complex located in Kirov Oblast","date":"29.04.2020","desc":"","link":"/en/news/companynews/danail-donchev-is-appointed-director-of-the-nanolek-biomedical-complex-located-in-kirov-oblast/","inner_date":"29.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Danail's duties will include implementing measures to organize development and management of process regulations; preparation of technical documentation, consumption rates of raw and auxiliary materials; arrangement of work processes and employee training; involvement in processes related to management of nonconformities, corrective and preventive actions as per GOST ISO 9001 and according to the Good manufacturing and quality assurance practices for pharmaceutical products (GMP).<br>\n<br>\nDanail holds a Master's degree in Chemical engineering (Asen Zlatarov Technical University, Bulgaria), a diploma in engineering from the Department of Processes & Systems Engineering (Otto von Guericke University, Germany), and a PhD (doctorate at the Engineering center of the Department of Thermal Process Technology, Martin Luther University, Germany).<br>\n<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/68f/NA-SAYT.jpg"},{"tag":"COMPANY NEWS","title":"April 28 NANOLEK Celebrates Its Anniversary","date":"28.04.2020","desc":"","link":"/en/news/companynews/april-28-nanolek-celebrates-its-anniversary/","inner_date":"28.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Dear friends, today, NANOLEK celebrates its birthday.\n</p>\n Although the holiday date fell on a difficult period, this is not a reason not to exchange warm words of support and good wishes. Today, we accept congratulations from our leaders, friends, colleagues, partners, and we want to share joyful moments with you.<br>\n <br>\n <b>Well-wishings from the NANOLEK President Vladimir Khristenko:</b><br>\n <br>\n<blockquote>\n\t \"Dear Colleagues, today is the anniversary of NANOLEK. For the pharmaceutical industry, NANOLEK is a very young company. Still, it has already succeeded in proving that it can do a lot. And this is our joint achievement. Of the entire NANOLEK team. I want to say THANKS for your indifference, involvement, professionalism, and dedicated work\".\n</blockquote>\n<p>\n</p>\n <b>Well-wishings from the General Director of NANOLEK Mikhail Nekrasov:</b><br>\n <br>\n<blockquote>\n\t<p>\n\t\t \"Dear colleagues, I wish you a happy anniversary of NANOLEK!I do not get tired of saying that you are NANOLEK's employees who are behind every success, every number, and every single package. A company is not about constitutional documents or walls of its offices, laboratories, and workshops. A company is PEOPLE, its team; I think - one of the best. For me, it is a great personal pride for what we were able to create together because I know what difficulties it cost us. I wish all our employees good health, good mood, inspiration, creativity, and drive\".\n\t</p>\n</blockquote>\n<h3>\nCONGRATULATIONS FROM OUR COLLEAGUES AND PARTNERS </h3>\n<p>\n <b>Matthias Wernike, the CEO of Merck in Russia and the CIS countries:</b><br>\n <br>\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t \"On this day, I want to convey the warmest congratulations on the anniversary of the company to the NANOLEK team! We are glad for our long and prosperous cooperation. Thanks to collectively implemented localised projects, millions of Russian patients receive uninterrupted medications for the treatment of cardiovascular and endocrine disorders. I wish NANOLEK positive and never-ending progress, continuous development, and new fulfillments!\"\n\t</p>\n</blockquote>\n<p>\n\t As you know, the biomedical complex NANOLEK is located in the Kirov Region. We are pleased to receive a congratulatory address from <b>Governor Igor Vladimirovich Vasiliev:</b>\n</p>\n<blockquote>\n\t<p>\n\t\t “I congratulate the NANOLEK team on the anniversary of the founding!\n\t</p>\n\t<p>\n\t\t This year, NANOLEK celebrates its 9th anniversary: the company is young, but ambitious, having proved its strength and power in the development of the domestic biopharmaceutical industry and entrepreneurship. NANOLEK laboratories are the basis for the development of Russian biotechnology. The company's production is an illustration of the effective implementation of international standards in the manufacture of innovative import-substituting drugs that save the lives and health of people in our country.\n\t</p>\n\t<p>\n\t\t Historically, the Kirov Region is a region of scientists, the scientific potential of the country. And I, as the head of the region, am pleased that the Vyatka land is home to the NANOLEK Biomedical Complex, which is one of the founders of the world-class scientific and educational centre Biopolis. It is also a scientific and production cluster securing the epidemiological safety and drug independence of our country, the future world leader in immunobiology, the flagship of the development of world science. To date, more than 700 highly qualified jobs have been created at BMK. With the development of Biopolis, their number will only increase. I wish every employee of the company a happy anniversary of NANOLEK, thank you for the dedication and commitment that you demonstrate every day in an uncertain epidemiological environment.\n\t</p>\n\t<p>\n\t\t I wish the company sustained growth, development, innovative projects, and successful work!\"\n\t</p>\n</blockquote>\n<p>\n\t Collaboration with significant players in the pharmaceutical market helps to do more to maintain health and save lives. We thank our partners from the company Sanofi for sweet words.<br>\n <br>\n <b>Oksana Monge, the CEO of Sanofi in the countries of the Eurasian region:</b><br>\n <br>\n</p>\n<blockquote>\n\t<p>\n\t\t \"Dear partners, company NANOLEK!\n\t</p>\n\t<p>\n <br>\n\t</p>\n\t<p>\n\t\t Accept the most sincere congratulations on behalf of Sanofi on your 9th Anniversary! In just a little less than a decade, you have managed to do a lot - created a world-class biopharmaceutical company that produces an extensive portfolio of the most modern medications that Russian patients need - vaccines, drugs for the treatment of HIV, cancer, built your high-tech manufacturing complex, joined partnerships with leading world companies, became one of the key participants in the Russian pharmaceutical market, daily contributing to the development of the domestic pharmaceutical industry.All these are the evidence of the high professionalism of the NANOLEK team, your determination, and faith in your work. We are proud of our partnership with NANOLEK and wish you continued successful development, prosperity, and implementation of strategic plans!\"\n\t</p>\n</blockquote>\n<p>\n <b>Congratulations from the head of the Moscow Innovation Cluster Anatoly Valetov:</b><br>\n</p>\n<blockquote>\n\t<p>\n\t\t “On behalf of the Cluster, let me congratulate NANOLEK on the company's day. NANOLEK, as a resident of the Moscow Innovation Cluster, is a participant in the innovation ecosystem and a driver of future technologies. The expertise gained by the founders of the company and its employees is precious in terms of developing the ties of our Cluster, which was founded for the introduction of innovations and cooperation between business, science, education, and the city.\n\t</p>\n\t<p>\n\t\t Dear colleagues, together, we will be able to expand the Cluster's intellectual capital, do a lot to strengthen the investment attractiveness of projects, set trends in innovative practice, and develop knowledge-intensive sections of the economy. The future is innovation. We wish you prosperity, discoveries, and breakthrough ideas!\"\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n\t \n</p>\n<p>\n <br>\n</p>\n<p>\n <br>\n</p>\n <br>\n <br>\n <br>\n <br>\n <br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/028/na-sayt-engl.jpg"},{"tag":"COMPANY NEWS","title":"The Kirov NANOLEK hits the list of backbone enterprises","date":"27.04.2020","desc":"","link":"/en/news/companynews/the-kirov-nanolek-hits-the-list-of-backbone-enterprises/","inner_date":"27.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Nanolek LLC, whose biotechnological production site is located in the Kirov Region (Orichevsky district, Levintsy), entered the list of systemically important organizations of the Russian economy. \n</p>\n<p>\n\t The decision to include the organization in the list was taken by the Government Commission created to increase the sustainability of the development of the Russian economy. The industry list was published on the website of the Ministry of Industry and Trade of Russia on April 25, 2020.\n</p>\n<p>\n\t The list of backbone organizations supervised by the Ministry of Industry and Trade of Russia includes organizations that meet the numerical criteria for the values of industry indicators established for industries also provides for some additional criteria. For pharmaceutical companies, there is a selection criterion - the revenue must be at least one billion rubles and the number of enterprises - at least 250. Let us remind you that the company's revenue for 2019 amounted to 7.5 billion rubles, which is 60% higher than in 2018 (4.7 billion). The number of employees is more than 700 people.\n</p>\n<blockquote>\n\t<p>\n\t\t\"NANOLEK is a high-tech company that produces vaccines and socially significant medications for the treatment of HIV, cancer, orphan disorders, etc. All divisions: research, production, and logistics continue to operate without interruption, performing all contractual obligations. Moreover, in the middle of restrictive measures that were taken in connection with the COVID-19 pandemic, as well as instability of exchange rates, we need to count on support from the government\", <b>said the company's executive director Maxim Stetsyuk.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"Companies included in the list of backbone organizations have the right for the individual support and assistance with debt refinancing\", <b>declared First Deputy Prime Minister Andrei Belousov.</b>\n\t</p>\n</blockquote>\n<h3>\nAbout the Company </h3>\n<p>\n\t NANOLEK is a modern fast-growing Russian biopharmaceutical company with its high-tech full-cycle production according to the GMP and ISO standards, which specializes in the manufacture of import-substituting and innovative medicines, both of its design and created with the involvement of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique expertise in the field of technology transfer in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc..). Nanolek LLC took first place in the category \"Fast-growing Large Companies\" TEKHUSPEKH -2019 ranking. The company was also a member of Minek's priority project \"Support for Private High-Tech Leading Companies\" (\"National Champions\") in 2017.\n</p>\n<p>\n\t \n</p>\n<p>\n\t Today, the company is one of the leaders in the production of pediatric vaccines in the Russian Federation. The diversified product portfolio of NANOLEK products is presented in the following therapeutic areas: vaccines, medications for the treatment of HIV, cancer, etc.\n</p>\n<p>\n\t \n</p>\n<p>\n\t August 14, 2019, Nanolek LLC left the list of RUSNANO portfolio companies.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/619/minpromtorg-na-sayt.jpg"},{"tag":"COMPANY NEWS","title":"The first domestic inactivated polio vaccine has been submitted for registration","date":"24.04.2020","desc":"","link":"/en/news/companynews/the-first-domestic-inactivated-polio-vaccine-has-been-submitted-for-registration/","inner_date":"24.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Small investment company Invak - Nanolek LLC Joint Venture and the Federal State Budgetary Institution for Health and Social Development named after M.P. Chumakov of the RAS - applied for registration the first domestic inactivated polio vaccine (IPV). The registration of the vaccine will make it possible in the future to uninterruptedly provide citizens of the Russian Federation with a highly effective and safe vaccine, which is included in the list of the National Calendar of Preventive Vaccinations (NKPP).\n</p>\n<p>\n\t The inactivated polio vaccine (IPV) on Sabin strains will be produced according to the technology developed by the Federal State Budgetary Institution of Scientific Research named after M.P. Chumakov of the RAS. The production of the finished dosage form is to take place at the NANOLEK site in the Kirov Region. The project provides for the construction of additional production facilities as part of the development of the Biopolis biotechnological immunobiological research and educational centre located in the Kirov Region. Both organizations are the participants of that centre.\n</p>\n<p>\n\t The planned production capacities will fully cover the additional needs of our state for the IPV - for the full transition to the inactivated polio vaccine within the framework of the NKPP of the Russian Federation and deliveries to the EAEU and other foreign markets within the context of cooperation with the UNICEF and WHO.\n</p>\n<p>\n\t The partnership of the Federal State Budgetary Institution for Health and Social Development named after M.P. Chumakov of the RAS and Nanolek LLC - a successful example of a public-private partnership to bring promising domestic developments to the market. Implementation at the NANOLEK site of the production of the vaccine developed by the Federal State Budgetary Institution of Scientific Research named after M.P. Chumakov of the RAS was made possible thanks to the production and technological competencies acquired by NANOLEK in the process of transfer and organization of production of the finished dosage form of the IPV fr om the substance (Bilthoven Biologicals).\n</p>\n<blockquote>\n\t<p>\n\t\t \"It is important to note the relevance of the project not only for Russia, wh ere the annual need for IPV has been estimated at 8 million doses but also for export potential. It consists, first of all, in a drastic shortage of IPV on the international market associated with the WHO polio elimination program and the systematic transition to the use of inactivated vaccines instead of living ones. According to experts, the export potential of IPV can be up to 20 million doses per year. Our institute produces substances on the territory of Russia. It has the permission of the WHO to supply vaccines for the needs of UN agencies (UNICEF),\" <b>noted the General Director of the Federal Scientific Research and Design Institute named after Chumakov Aidar Ishmukhametov.</b>\n\t</p>\n</blockquote>\n<p>\n\t According to the Central Research Institute of Epidemiology of Rospotrebnadzor, 95% of the population is required to prevent the occurrence of epidemics of dangerous diseases. The problem was also identified in Presidential Decree No. 97 of March 11, 2019, which approved the Fundamentals of the state policy of the Russian Federation in the field of ensuring a chemical and biological safety until 2025 and for the future. The primary biological threats are the absence of specific immunity in the population to individual infections controlled by preventive measures, i.e., vaccinations.\n</p>\n<blockquote>\n\t<p>\n\t\t \"In the current epidemiological situation, the WHO European Region recommends that each country take all possible measures to maintain a high level of population immunity. Prioritise primary vaccine complexes, especially when it comes to vaccines containing measles and rubella or polio components and other combined vaccines. We, at NANOLEK, see this as our primary task - to meet the needs of the Ministry of Health of Russia with effective, safe, and high-quality vaccines, the production of which is organised in the Russian Federation\", <b>said the Executive Director of NANOLEK Maxim Stetsyuk.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"MIP Invak can become a new model of cooperation, which will fully allow implementing the scientific potential of domestic research centres in partnership with proven vaccine manufacturers and the necessary experience on the most modern international quality standards,\" <b>said Yuri Tikhonovich Kalinin, President of the Rosmedprom Association, chairman of the RUIE Commission for the pharmaceutical and medical industries.</b>\n\t</p>\n</blockquote>\n<p>\n\t The IPV is the first project of MIP Invak. It is being implemented as part of the country's development of immunobiological safety and the transition to the production of full-cycle vaccines. It is planned that at the end of 2020, the production of the finished dosage form will begin with the release of the substance in 2023. The plans of the Invak enterprise include the full-cycle production of other vaccines for immunization of the population of the Russian Federation under the NKPP, taking into account its future needs.\n</p>\n<p>\n\t Poliomyelitis\n</p>\n<p>\n\t According to the World Health Organization, poliomyelitis is a threatening disease caused by the virus. It affects the nervous system and can lead to general paralysis in a matter of hours. The virus is transmitted from person to person, mainly through some common carrier of infection (for example, contaminated water or food). In one out of 200 diseases, irreversible paralysis (usually of the legs) takes place. About 5-10% of such paralysed people die due to the onset of respiratory muscle paralysis.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/592/ppppppppp1.jpg"},{"tag":"COMPANY NEWS","title":"Adsorption columns for the treatment of severe complications of viral pneumonia were delivered to the Clinic of Moscow State University, which was opened by Sobyanin and Sadovnichy","date":"23.04.2020","desc":"","link":"/en/news/companynews/adsorption-columns-for-the-treatment-of-severe-complications-of-viral-pneumonia-were-delivered-to-th/","inner_date":"23.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Mayor of Moscow Sergey Sobyanin and rector of MSU Viktor Sadovnichy opened on Tuesday, April 21, a coronavirus hospital located on the premises of the University Clinic - the Medical Research and Educational Center of MSU on Lomonosovsky Prospekt.\n</p>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t \"I acted in cooperation with Viktor Antonovich to ensure supplies of process equipment, therefore the MSU Clinic is one of the best in terms of infrastructure and equipment,\" <b>said mayor of Moscow Sergey Sobyanin.</b>\n\t</p>\n</blockquote>\n<p>\n\t The MSU Clinic was transformed into a hospital to treat coronavirus patients, which made it possible to accommodate 100 beds for patients sick with coronavirus and 24 critical care beds. The in-patient facility boasts state-of-the-art medical equipment, including two CT scanners, one MRI scanner, 16 ventilators and 22 anaesthetic and respiratory apparatuses.\n</p>\n<blockquote>\n\t<p>\n\t\t \"We are receiving more and more reports fr om various physicians who share their successful experience of using our products, adsorption columns. The core of our team is made up of graduates of Moscow State University, and our company is a resident of the MSU Science Park, that is why it is especially difficult for us to stand on the sidelines. We joined efforts with our partners from NANOLEK to deliver a batch of devices to the University clinic for free, and I hope that this will help preserve people's health,\" <b>commented Ivan Bessonov, co-founder and Technical Director of Efferon, on his decision.</b>\n\t</p>\n</blockquote>\n<p>\n\t Earlier, Nanolek and Efferon also donated adsorption columns to the state budgetary healthcare institution of Moscow \"City clinical hospital No. 40\" in Kommunarka that treats patients with a new coronavirus infection.\n</p>\n<blockquote>\n\t<p>\n\t\t \"We are glad that medical devices developed by residents of the MSU Science Park in partnership with scientists of MSU will help in the fight against complications following coronavirus infection,\" <b>said Maxim Stetsyuk, Executive Director of NANOLEK.</b>\n\t</p>\n</blockquote>\n<p>\n <b>Background information</b>\n</p>\n<p>\n\t Efferon JSC is a resident of the Science Park of Lomonosov Moscow State University and Skolkovo Foundation. The company produces adsorption columns \"Efferon CT\" and \"Efferon LPS\".\n</p>\n<p>\n\t Nanolek LLC is a Russian biopharmaceutical company with its own high-tech full-cycle production according to GMP standards, which specializes in the production of vaccines, drugs for the treatment of HIV, cancer and other diseases.\n</p>\n<p>\n\t The first device - \"Efferon CT\" - is intended to treat acute respiratory distress syndrome (severe lung damage in patients with pneumonia). The second column — \"Efferon LPS\" - can be used to purify blood in sepsis which can develop in a weakened body during long-term treatment and in cases wh ere artificial ventilation (ventilators) is used.\n</p>\n<p>\n\t \n</p>\n <br>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/ebf/pOLIKLINIKA.jpg"},{"tag":"COMPANY NEWS","title":"Employees of NANOLEK support the All-Russian flash mob","date":"17.04.2020","desc":"","link":"/en/news/companynews/employees-of-nanolek-support-the-all-russian-flash-mob/","inner_date":"17.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t We have supported the All-Russian flash mob <span style=\"color: #00aeef;\">#\"We Stay At Your Disposal Seven Days A Week\"</span>, which was recently launched by agricultural enterprises.<br>\n <br>\n\t We take the baton over from farmers, send them regards and wish them ample harvest! The floor is now turned over to the PHARMACEUTICAL DIVISION.<br>\n <br>\n\t NANOLEK biopharmaceutical company keeps working 7 days a week for you, dear Russians. Without a single day of downtime, without doubting for a minute or hesitating for a second. We go always forward.<br>\n <br>\n\t We keep guard over the health of the BIG COUNTRY.<br>\n <br>\n\t Everyone is doing their job on their workplaces (while observing safety regulations), so that life-saving medicines come in the required volume on time and uninterruptedly to save and protect people's lives and health. And this flash mob is a great reason to take a look at the labs and production halls of the pharmaceutical plant, access to which is normally almost impossible.<br>\n <br>\n\t We encourage our fellow pharmacists to hit on the idea and show how we work in unison and don not panic.<br>\n <br>\n\t Please watch the video showing employees of BMC NANOLEK by following the link and clicking on <b>\"Source\"</b>.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/88f/fleshmob.jpg"},{"tag":"COMPANY NEWS","title":"Participants of the Moscow Innovation Cluster donate medical devices to the hospital in Kommunarka to treat complications in COVID-19 patients","date":"16.04.2020","desc":"","link":"/en/news/companynews/participants-of-the-moscow-innovation-cluster-donate-medical-devices-to-the-hospital-in-kommunarka-t/","inner_date":"16.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n <i>A joint project organized by the members of the Moscow Innovation Cluster will save the lives of patients who have caught the coronavirus. Sorption columns for the treatment of severe complications of viral pneumonia were delivered to the medical staff in the City clinical hospital No. 40 in Kommunarka.</i>\n</p>\n<p>\n\t The participants of the Moscow Innovation Cluster (MIC), which is subordinate to the Moscow Department of entrepreneurship and innovative development — Nanolek and Efferon — donated their in-house developed medical devices for the treatment of severe complications in patients with COVID-19. They were admitted to the state budget healthcare institution of Moscow \"City clinical hospital No. 40\" in Kommunarka that treats patients with a new coronavirus infection.\n</p>\n<p>\n</p>\n<p>\n\t The first device - \"Efferon CT\" - is intended to treat acute respiratory distress syndrome (severe lung damage in patients with pneumonia). The second column — \"Efferon LPS\" - can be used to purify blood in sepsis which can develop in a weakened body during long-term treatment and in cases where artificial ventilation (ventilators) is used.\n</p>\n<blockquote>\n\t<p>\n\t\t \"Our partners and we want to help doctors who are at the forefront of the fight against the pandemic. We follow international publications and read a lot about anti-cytokine sorption that can improve the condition of the most severe patients with coronavirus pneumonia by reducing peak levels of IL-6 and other cytokines. We hope that the adsorbers we have received will be in demand \"on the front line\" and help survive this difficult period. I take this opportunity to congratulate Denis Nikolayevich Protsenko on the encouraging news of his recovery, and on behalf of all our team we wish him good health and energy to continue his efforts under challenging conditions,\" <b>said Ivan Bessonov, co-founder and Technical Director of Efferon.</b>\n\t</p>\n</blockquote>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t \"The priority task today is to reduce the percentage of deaths and severe complications in patients. Therefore, we as a socially responsible company want to donate medical devices that will help reduce the mortality rate and reduce the time spent by patients with severe SARS-CoV-2 (COVID-19) in intensive care units\", <b>said Maxim Stetsyuk, Executive Director of Nanolek.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t \"Cooperation of participants in launching much-in-demand technology solutions to the market is one of the major tasks of creating a digital platform for the Moscow Innovation Cluster. The strategic partnership between Nanolek and Efferon serves as good example of effective cooperation within the platform\", <b>emphasized Alexey Fursin, Head of the Department of Entrepreneurship and Innovative Development.</b>\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n\t \n</p>\n<p>\n <br>\n</p>\n<p>\n <br>\n</p>\n<p>\n <br>\n</p>\n<p>\n <br>\n</p>\n<p>\n <br>\n</p>\n<p>\n\t \n</p>\n<p>\n <br>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/576/kommunarka.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK summarizes financial and production results of 2019","date":"14.04.2020","desc":"","link":"/en/news/companynews/nanolek-summarizes-financial-and-production-results-of-2019/","inner_date":"14.04.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n <b>FIGURES </b>\n</p>\n <b> </b>\n<p>\n</p>\n<ul>\n\t<li>\n\tIn 2019, the company’s earnings totalled RUB 7.5 bn, which is 60% higher than in 2018 (RUB 4.7 bn). </li>\n\t<li>\n\tThe total amount of investments exceeds RUB 500 mln. </li>\n\t<li> NANOLEK’s R&D experts evaluated 80 new medication ideas.</li>\n\t<li>\n\t5 new registration certificates for medications were received (4 in the Russian Federation and 1 in Azerbaijan).</li>\n</ul>\n<p>\n</p>\n<blockquote>\n\t<p>\n\t\t “We are happy with our results, the company demonstrates sustainable growth that hopefully will persist inspite of current market fluctuations,” <b>said Vladimir Khristenko, President of NANOLEK.</b>\n\t</p>\n</blockquote>\n<p>\n <b>WITHDRAWAL FROM THE LIST OF RUSNANO PORTFOLIO COMPANIES</b><br>\n</p>\n<blockquote>\n\t<p>\n\t\t “NANOLEK became an independent company, now we count on our efforts only, and I believe in our team, we will move forward in accordance with our development strategy,” <b>said Vladimir Khristenko, President of NANOLEK.</b>\n\t</p>\n</blockquote>\n<p>\n\t As of August 14, 2019, Rosnano JSC ceased to be a member of the Russian biopharmaceutical company NANOLEK after selling its 33.33% stake in the charter capital to other shareholders. The proceeds of sale exceeded the amount of investments by two times and amounted to RUB 2.35 bn.\n</p>\n<p>\n <b>VACCINE BUSINESS DEVELOPMENT AND SUPPLIES UNDER GOVERNMENTAL CONTRACTS</b>\n</p>\n<p>\n\t In 2019, the company continued strengthening its positions in the vaccine business, being NANOLEK’s priority. \n</p>\n<p>\n\t NANOLEK proceeded to the third stage of pneumococcal vaccine clinical research. This project assumes gradual transfer of technologies resulting in the establishment of a full vaccine production cycle in the Russian Federation.\n</p>\n<p>\n\t Usually, children under 5 years and elderly people suffer from pneumococcal disease. Diseases induced by pneumococcus are dangerous and may result in severe complications. Vaccination helps decrease the number of severe invasive pneumococcal infections, pneumonia cases and therefore cut healthcare costs and increase the length and quality of life of patients suffering from chronic non-specific lung diseases.\n</p>\n<p>\n\t Several agreements were concluded with companies in order to continue development of NANOLEK’s vaccine business, being the company’s priority:\n</p>\n<p>\n</p>\n<ul>\n\t<li>Sanofi Pasteur - the project to localize production of a combined conjugated vaccine for meningococcal disease prevention was launched. The partnership will broaden opportunities for protection of Russian children from meningococcal disease (MD).</li>\n\t<li>Creation of a joint venture INVAK together with the Chumakov Scientific Centre was a landmark event. The company will produce the first entirely domestic inactivated polio vaccine (IPV). This project illustrates the process of transfer from localisation of a medication to a complete production cycle, which is one of NANOLEK’s priorities.</li>\n</ul>\n<p>\n</p>\n<p>\n\t In 2019, a 2-years’ governmental contract for vaccine supply for the National Vaccination Schedule (for 2019-2020) was concluded for the first time in NANOLEK’s history. Under the contract, NANOLEK fulfilled the first year’s obligations in full: it successfully completed the first stage of supplies of a paediatric five-component combined vaccine (Pentaxim®) produced by the Nanolek’s biomedical cluster. In total, 3.5 mn vaccine doses were produced and supplied in 2019, which allowed protecting approx. 1 mn children from five dangerous infections, i.e. tetanus, pertussis, diphtheria, poliomyelitis and haemophilus influenzae type b.\n</p>\n<p>\n\t We would like to remind you that haemophilus influenzae type b vaccination is currently made for risk groups only, while the protection of healthy children from this infection is achieved either according to the regional schedules (Moscow, Saint-Petersburg and several other regions) or on parent’s account. Currently, only three countries, including Russia, have not introduced the haemophilus influenzae type b vaccines as part of the scheduled immunisation of all children during the first years of life according to vaccination schemes recommended by the WHO.\n</p>\n<p>\n <b>MEDICATION PORTFOLIO</b>\n</p>\n<p>\n\t NANOLEK focuses on prevention and treatment of socially significant diseases. NANOLEK’s diversified product portfolio includes drugs for treatment of HIV, orphan, oncological diseases, etc.\n</p>\n<p>\n <b>Partnerships</b>\n</p>\n<p>\n\t The company pays great attention to developing of partnerships with major industry players. In 2019, long-term agreements for production and transfer of technologies were concluded with leading corporations:\n</p>\n<p>\n</p>\n<ul>\n\t<li>NANOLEK strengthened its oncological drug portfolio by launching a joint project with Janssen in order to localize Darzalex® (daratumumab) used to treat multiple myeloma. The medication is the first human monoclonal anti-CD38 antibody approved for this type of disease;</li>\n\t<li>NANOLEK and Merck announced the launch of a complete production cycle of one of key medications Concor® used to treat arterial hypertension, coronary heart disease and chronic cardiac failure. The medication will be produced by NANOLEK’s production plant in Kirov region in full compliance with the GMP standards;</li>\n\t<li>For the first time in its history, NANOLEK enters the veterinary vaccine market, an agreement was signed with the market leader MSD Animal Health (full-cycle production of veterinary vaccines in Russia).</li>\n</ul>\n<p>\n</p>\n<p>\n <b>Medications to treat HIV</b>\n</p>\n<p>\n\t In 2019, NANOLEK registered its own prescription drug Atazanavir-NANOLEK® to treat HIV. The complete production cycle of a finished dosage form will be produced at NANOLEK’s production site in Kirov region with a capacity to produce more than 100 thousand packs per year, while the price of the medication will be lower than that of analogues available in the market. In May 2019, Darunavir-NANOLEK® was registered (thus, in 2019, the ART drug portfolio includes the following medications: atazanavir, darunavir, lamivudine-zidovudine, tenofovir, efavirenz as well as valganciclovir also used to treat cytomegalovirus infection).\n</p>\n<p>\n <b>Orphan diseases</b>\n</p>\n<p>\n\t The first stage of localisation of production of an original medication Hunteraza® (idursulfase beta) in the Russian Federation used to treat the orphan disease mucopolysaccharidosis type 2 (MPS 2), being a severe disease that causes disability, was completed. Since January 1, 2019, MPS 2 has been included in the 14 Nosologies List (NL) and is financed at the expense of the federal budget. In February 2019, Hunteraza® was included in the standards for Hunter syndrome treatment.\n</p>\n<p>\n\t Today, NANOLEK is the only Russian company that has set up a local production in Russia to manufacture drugs for the treatment of this disease. The drug is produced at NANOLEK’s biopharmaceutical complex in Kirov region. This allows ensuring continuous supplies of this medication to Russian patients suffering from this rare disease. The domestic production also helps decrease financial burden on the federal budget as the price of use of Hunteraza® is more than 20% lower as compared to the alternative enzyme replacement therapy method.\n</p>\n<p>\n <b>DRUG LABELING</b>\n</p>\n<p>\n\t NANOLEK was one of the first companies to implement the Labeling project. On November 21, 2019, NANOLEK’s biomedical complex in Kirov region manufactured a labelled commercial batch of Hunteraza® used to treat the orphan disease mucopolysaccharidosis type 2 (MPS 2) included in the 14 Nosologies List. The Company has successfully implemented the labelling software and hardware. The active testing of communication exchange in the system for medication flow monitoring was completed together with partners. Today, we also produce labelled Fraxiparine at our biotechnological production facility in Kirov, and we prepare production of labelled series of Pentaxim® combined vaccines supplied for the needs of the National Vaccination Schedule.\n</p>\n<p>\n <b>CORPORATE SOCIAL RESPONSIBILITY, </b><b>TAX PAYMENTS TO THE BUDGET OF KIROV REGION</b>\n</p>\n<p>\n\t Please keep in mind that NANOLEK’s production biotechnological complex is located in Kirov.\n</p>\n<p>\n\t NANOLEK is a socially responsible company that pays great attention to the development of the Kirov region. Currently, more than 700 workplaces for highly skilled workers have been created at NANOLEK’s biopharmaceutical complex, of which 170 employees graduated from the Vyatka State University, 35% are the specialists in the area of biotechnologies.\n</p>\n<p>\n\t NANOLEK is one of the founders of the industrial biotechnology cluster in Kirov region established at the initiative and with active participation of Igor Vasilyev, Governor of Kirov region.\n</p>\n<p>\n\t In 2019, NANOLEK became a member and one of the founders of a world-class research and education centre BIOPOLIS in Kirov region. Other members of the association include Kurchatov Institute National Research Center and Chumakov Federal Scientific Center for Research and Development of Immunobiological Drugs of the Russian Academy of Sciences. The main goal behind the creation of the research and education centre was to build a distributed scientific and production cluster, a tool to achieve a global leadership in immunobiology, one of the most promising areas of world science development.\n</p>\n<p>\n\t As part of research and education centre’s activities, it will develop new drugs in order to ensure epidemiological safety and medicinal independency of the country, develop innovation technologies for the production of those drugs and arrange projects for their implementation. Training and advanced training of qualified scientific, technical and managerial workers along with international cooperation will become an important part of center’s operations.\n</p>\n<p>\n\t NANOLEK makes its contribution to the regional fiscal capacity (by paying taxes to the local budget). In 2019, tax payments totalled approx. RUB 100 mn, which is 2.5 times more than in 2018 (RUB 40 mn).\n</p>\n<p>\n <b>COOPERATION WITH UNIVERSITIES. Basic University: Vyatka State University</b>\n</p>\n<p>\n\t NANOLEK entered into a cooperation agreement with the Vyatka State University. Today, NANOLEK employs 170 graduates of the Vyatka State University.\n</p>\n<p>\n\t NANOLEK’s representatives take an active part in the life of the basic university. In spring, NANOLEK arranged an excursion into its production facility for schoolchildren specialising in Chemistry and Biology as part of the VIII Week of High Technologies and Technical Entrepreneurship. The schoolchildren visited several laboratories (chemical and analytical, microbiological, biochemical) and inspected all production premises and equipment; NANOlock intellectual game was organised for students.\n</p>\n<p>\n\t In June 2019, NANOLEK’s employees acted as members of the state attestation board, and in July they assessed bachelors and future microbiologists’ theses.\n</p>\n<p>\n <b>AWARDS AND RANKING</b>\n</p>\n<p>\n\t In 2019, Mikhail Nekrasov, General Director of NANOLEK, was awarded the Annual Prize “Person of the Year 2019. Large Business and Social Sector” in the nomination “Production Man of the Year”. The award ceremony was held by the Business Class magazine supported by the Government of the Kirov region.\n</p>\n<p>\n\t We would like to remind you that Mikhail Nekrasov is in his second year in office as deputy of the Legislative Assembly of the Kirov region. He is a member of the Committee for Environmental Safety and Natural Resource Management as well as the Committee on Social Affairs. He monthly receives local dwellers at the public reception office to address local issues, actively participates in regional social and cultural events. In 2019, he supported the following events: the 39th All-Russian Ski Marathon Shizhma, traditional festival Istobensky Ogurets, ХIХ Intermunicipal Rifle Shooting Competition.\n</p>\n<p>\n\t In 2019, NANOLEK was awarded a prestigious national award in import substitution and transfer of technologies Prioritet-Pharma for the development and establishment of production of the inactivated polio vaccine and was ranked first in the category Fast Growing Major Companies of the reputable TekhUspekh rating evaluating Russian companies that rapidly evolve, demonstrate dynamic turnover and innovative technologies in their work.\n</p>\n<p>\n\t NANOLEK managers were listed in the Top-1000 Russian Managers rating released by the Managers Association of Russia and Kommersant Publishing House:\n</p>\n<p>\n</p>\n<ul>\n\t<li>\n\tTop-250 Senior Managers: Vladimir Viktorovich Khristenko, President; </li>\n\t<li>\n\tTop-100 Commercial Directors: Maksim Viktorovich Stetsyuk, Executive Director. </li>\n</ul>\n<p>\n</p>\n<p>\n\t \n</p>\n<p>\n\t \n</p>\n<p>\n\t \n</p>\n<p>\n\t \n</p>\n <br>\n<p>\n <i>NANOLEK is a modern fast-evolving Russian biopharmaceutical company with its own high-tech complete cycle production compliant with GMP and ISO standards. NANOLEK specialises in the production of import-substituting and innovative pharmaceuticals, both in-house developed and invented with the help of international partners, focusing on the prevention and treatment of socially significant diseases. The company has unique experience in the area of transfer of technologies as part of partnership with the leading international pharmaceutical companies (Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.)</i>\n</p>\n <i> </i>\n<p>\n <i>\n\tThe company is now one of the Russia’s leading producers of paediatric vaccines. NANOLEK’s diversified drug portfolio covers the following therapeutic areas: vaccines, drugs for treatment of HIV, oncological diseases, etc. </i>\n</p>\n <i> </i>\n<p>\n <i>\n\t </i>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/ca3/ppppppppp.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK and EFFERON: New Technologies to Combat Coronavirus","date":"31.03.2020","desc":"","link":"/en/news/companynews/nanolek-and-efferon-new-technologies-to-combat-coronavirus/","inner_date":"31.03.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Nanolek and Efferon announce the launch of a strategic partnership for taking active efforts to market a specialized medical device that can also be used in treatment of acute respiratory infections caused by SARS-CoV-2 (COVID-19).\n</p>\n<p>\n\t Efferon, which is a resident of the Science Park of Moscow State University and the Skolkovo Foundation Biomedical Cluster, has developed and is now producing two new medical devices for extracorporeal therapy – Efferon CT absorption columns to relieve cytokine storm syndrome and treat acute respiratory distress syndrome (ARDS), and Efferon LPS for the treatment of sepsis and septic shock, whose most common pathogenetic causes are bacterial lipopolysaccharides. Both medical devices received market authorization granted by Roszdravnadzor and are approved for use in clinical practice.\n</p>\n<blockquote>\n\t<p>\n\t\t “It is known that SARS-CoV-2 causes atypical pneumonia (COVID-19) which is accompanied by life-threatening complications: firstly, acute respiratory distress syndrome (ARDS) and secondly, sepsis that can develop in a weakened body during a difficult treatment process, including with the use of ventilators. The experience of physicians from Wuhan, the epicenter of the new epidemic, shows that extracorporeal blood purification can stop the progression of such complications.\n\t</p>\n\t<p>\n\t\t The blood of a patient is pumped under low pressure through a plastic cylindrical column filled with a special absorbent polymer. The surface of the absorbent selectively binds the spectrum of therapeutic targets. The purified blood flows back to the circulatory system, and the toxic substances firmly bound to the absorbent are removed from the body and disposed of. In recent years, extracorporeal blood purification has been widely and successfully used in treatment of critical conditions, and has recently been included in the Chinese recommendations for the treatment of atypical pneumonia in patients with SARS-Cov disease,” <b>explained Ivan Bessonov, Co-Founder and Technical Director of Efferon.</b>\n\t</p>\n</blockquote>\n<p>\n\t The Efferon LPS and Efferon CT columns are currently successfully used in a number of clinics in Moscow, St. Petersburg, Rostov-on-Don, Nizhny Novgorod, Surgut and other cities across the Russian Federation in the treatment of sepsis, bacterial-viral pneumonia, acute respiratory distress syndrome (ARDS) and the cytokine storm.\n</p>\n<blockquote>\n\t<p>\n <b>V.B. Chentsov, Head of the Anesthesiology and Resuscitation Department, IDH (infection disease hospital) No. 2, Candidate of Medical Sciences, Senior Anesthesiologist and Resuscitationist:</b>\n\t</p>\n\t<p>\n\t\t “When using the Efferon CT column in a patient with acute respiratory distress syndrome, which developed as a result of viral pneumonia caused by AH1N1 flu, we saw a distinct improvement of health condition. Oxygenation increased rapidly (for example, from 86% when using pure oxygen to 100% with oxygen mixture).”\n\t</p>\n</blockquote>\n<p>\n\t The Efferon LPS column is also used in treatment of sepsis.\n</p>\n<blockquote>\n\t<p>\n <b>N.D. Ushakova, Anesthesiologist and Resuscitationist, Department of Anesthesiology and Resuscitation, Rostov Research Center for Oncology, MD, professor, MD:</b>\n\t</p>\n\t<p>\n\t\t “When performing surgery in a patient with lung cancer suffering from lung destruction, absessed paracancerous pneumonia, one of abscess areas was drained and pus entered the pleural and pericardial cavities . Since the patient was in an extremely critical condition (mechanical ventilation, vasopressor support) and developed an acute lung damage based on clinical laboratory and X-ray findings and didn’t show positive response to treatment, a hemoperfusion using the Efferon LPS column was made a day after the operation along with intensive care.\n\t</p>\n\t<p>\n\t\t As early as two hours after the completion of the procedure, the hemodynamics were stabilized, interleukin-6 in blood decreased significantly, vasopressor support was waived. On the third day of the postoperative period after complete recovery of consciousness and muscle tone, the patient was treated with non-invasive ventilation. On the fifth day the patient was transferred to a specialized department for further treatment. This is an illustrative clinical example showing the possibility to prevent the development of acute lung damage in surgically wounded patients following radical thoracoscopic surgery”.\n\t</p>\n</blockquote>\n<p>\n</p>\n<p>\n</p>\n<p>\n</p>\n<p>\n\t According to the WHO, for every 100,000 people, about 200 cases of blood poisoning (sepsis) are recorded and this figure is growing annually. Throughout the world, sepsis is also one of the leading causes of death in medical institutions: from 30% to 60% of cases of this disease result in the death of the patient.\n</p>\n<blockquote>\n\t<p>\n\t\t “Right now, the partnership between Nanolek and Efferon is becoming even more important, since the method of selective hemosorption has proven to be effective in countries such as Italy, China, Panama, and others. We hope to use it on a regular basis in treatment of pneumonia caused by SARS-CoV-2, and in our country. One of the worst consequences of this virus is acute respiratory distress syndrome (ARDS). According to the Russian Ministry of Health, excessive response of the immune system with a rapidly developing fatal cytokine storm play a major role in the pathogenesis of ARDS caused by SARS-CoV-2 infection. Studies have shown that mortality with COVID-19 is also associated with increased levels of interleukin-6 (IL-6).\n\t</p>\n\t<p>\n\t\t The principle of the Efferon CT column is to bind any excess of tissue-damaging cytokines, such as IL-6 and IL-8, etc. The use of such a hemosorption column lowers mortality of patients and the length of time spent in intensive care, and reduces the need for ventilators which are so desperately required today. This is especially important since almost half of patients with severe lung damage from coronavirus are people under 60 years of age, making up 45% of the total number of patients in a severe condition according to Interfax. 15% of patients in a severe condition are under the age of 40,” <b>says Vadim Kalinichenko, Head of the Nanolek Medical Department.</b>\n\t</p>\n</blockquote>\n<blockquote>\n\t<p>\n\t\t “We need a strong partner – a Russian company that has extensive experience in launching drugs with various applications to market. We are pleased that we and Nanolek have similar history and share common principles of doing business. Our colleagues from Nanolek created a start-up and are fully aware of challenges in the fleding period. We colloborate with each other easily and comfortably as we share a common language and have a common goal, which is to provide people with access to the best global technologies. We are confident that with the team of Nanolek will help us expand the range of applications of our device and make it available for patients in Russia,” <b>says Ivan Bessonov.</b>\n\t</p>\n</blockquote>\n NANOLEK is ready to supply Efferon columns directly to medical facilities. \n<p>\n\t About EFFERON\n</p>\n<p>\n\t Efferon was established in 2017 by graduates of the Department of Chemistry of Lomonosov Moscow State University and INEOS RAS (Nesmeyanov Institute of Organoelement Compounds of the Russian Academy of Sciences). The company is a resident of the Science Park of Moscow State University and the Skolkovo Foundation Biomedical Cluster. It has developed and is now producing two new medical devices - Efferon CT absorption columns for the treatment of cytokine storm syndrome and acute respiratory distress syndrome (ARDS), and Efferon LPS for the treatment of sepsis and septic shock. Both medical devices received market authorization granted by Roszdravnadzor and are approved for use in clinical practice. The columns have been successfully tested at the Medical Scientific and Educational Center of Lomonosov Moscow State University, City Clinical Hospital No. 67 named after L.A. Vorokhobov, City Clinical Hospital No. 1 named after N.I. Pirogov, Infectious Diseases Hospital No. 2, National Medical Research Center of Oncology (Rostov-on-Don) and many other advanced medical institutions.\n</p>\n<p>\n\t About NANOLEK\n</p>\n<p>\n\t Nanolek is a modern, fast-growing Russian biopharmaceutical company with its own high-tech full-cycle production facility that meets GMP standards, specializing in the production of innovative and generic drugs, developed both by the company and in collaboration with international partners, with a focus on the prevention and treatment of socially significant diseases. Today, the company is one of the leading producers of pediatric vaccines in Russia. NANOLEK’s diversified medicinal product portfolio features following areas: vaccines, drugs for treatment of HIV, cance, etc. The company has unique experience in the transfer of technologys in collaboration with leading global pharmaceutical companies.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/80c/na-sayt.jpg"},{"tag":"COMPANY NEWS","title":"Address of the Company's management to employees: NANOLEK is among the companies that take urgent action in emergency situations","date":"27.03.2020","desc":"","link":"/en/news/companynews/address-of-the-company-s-management-to-employees-nanolek-is-among-the-companies-that-take-urgent-act/","inner_date":"27.03.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tDear Colleagues,<br>\n <br>\n on March 25, 2020, President of Russia Vladimir Putin delivered a speech addressing all Russians and this event could not be disregarded. It is perfectly right that the head of state personally addressed the nation and made the necessary decisions that will help our country counteract the pandemic.<br>\n <br>\n NANOLEK is a big family, therefore we are now addressing each one of you. Our trade is among the the most sought-after industries nationwide. It is usual practice for everyone of us to visit the pharmacy at least once a week: to buy vitamins or basic supplies for your home first aid kit. But let's just think about people who need vital and essential drugs, without which their health would be at risk of deteriorating significantly, and children would not be protected against life-threatening and vaccine-preventable infections. <br>\n <br>\n We can't relax while taking care of these people and we do not have a moral right to act like this at that difficult time for our country and the rest of the world. We can not stop production, suspend all supply chains, stop development and go on leave. NANOLEK means not just callous production lines, NANOLEK means first of all PEOPLE, that is, US and YOU. <br>\n <br>\n The experience of the previous week shows that employees not directly involved in production are able to maintain the continuity of processes by working from home. Able to secure a solid foundation for the development of our company in the future. All our employees who once opted for pharmaceutical science are responsible for the lives and health of people requiring our drugs on a daily basis. <br>\n <br>\n Our mission never changes at any time: We protect the lives and health of people, making the world's best technologies available to everyone.<br>\n <br>\n We believe that our staff form a real team. It's time to prove that the Company's values are not just lofty rhetoric, but words supported by real action. <br>\n <br>\n <b><i>NANOLEK has to meet its obligations to people in need of our drugs.</i></b><br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/ce2/nanolek_news.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is ready to share its experience in the implementation of labelling","date":"27.03.2020","desc":"","link":"/en/news/companynews/nanolek-is-ready-to-share-its-experience-in-the-implementation-of-labelling-/","inner_date":"27.03.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\"We have gone through challenging times where we made every effort to fine tune all the production processes. Therefore, we know the difficulties behind the implementation like no one else. It's not so easy e.g. to tune up the equipment without any help from foreign colleagues who have vast experience in this area and considering the complexity of IT solutions.<br>\n<br>\nNanolek was one of the first pharmaceutical providers in the market to produce a labelled drug series. This happened in November 2019.<br>\nCurrently, our biotechnological production cluster in Kirov manufactures labelled drugs \"Hunterase\" (supplied as part of the cost-intensive nosology program (VZN)) and \"Fraxiparine\", and is gearing up for the production of a labelled series of combined vaccine \"Pentaxime®\" to satisfy the needs of the National vaccination calendar.<br>\n<br>\nNotwithstanding the fact that we are entirely prepared for supplies of labelled products, the coronavirus pandemic is reshuffling plans, and based on that we support the request by the Association of Russian pharmaceutical manufacturers (ARFP) to postpone the launch of mandatory labelling. The current situation around COVID-19 constitutes a force majeure and largely affected the introduction of labelling at many pharmaceutical companies. <br>\n<br>\nTherefore, keeping in mind that we support the idea of labelling (it will definitely help track the movement of pharmaceuticals at every stage and protect the end user by making the market completely transparent), we are ready to join the working party together with representatives of the Association of Russian pharmaceutical manufacturers (ARFP) and help our colleagues regarding any questions arising. We can look back on extensive experience and have well-trained employees\", said Maxim Stetsyuk, Executive Director of NANOLEK.<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bb5/MG_0185-_1_.jpg"},{"tag":"COMPANY NEWS","title":"Information letter for partners to notify of NANOLEK's adherence to normal business practice","date":"19.03.2020","desc":"","link":"/en/news/companynews/information-letter-for-partners-to-notify-of-nanolek-s-adherence-to-normal-business-practice/","inner_date":"19.03.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Dear colleagues and partners,<br>\ngiven the current situation around the coronavirus pandemic, which affects the business processes of most companies and enterprises worldwide, we would like you to know that NANOLEK sticks to its normal operations as before. <br>\n<br>\nBased on the latest data received from our HR Department, all our employees, both on the shop floor and in office, continue to work at full pace, and none of them has shown any symptoms of coronavirus disease so far.<br>\n<br>\nWe have warned employees of all departments of epidemiological safety, rules of conduct amidst the spread of the virus, purchased antibacterial cleaners and disinfectants, installed bactericidal air recirculators in premises. <br>\n<br>\nNANOLEK positions itself as a high-tech company, therefore we have necessary tools to arrange remote work practices. Since we have previously taken necessary efforts to digitize all our data and considering our daily remote communication with partners and employees of our production facility in Kirov, we were able to quickly set up and implement remote work patterns for a number of employees of the Moscow office. This is a preventive measure that helps employees avoid crowded places (subway and other means of public transport).<br>\n<br>\nWe have adopted enhanced security measures at the NANOLEK production facility in the Kirov region in line with the best global practices. Moreover, we have set up an emergency response team to counteract the spread of the virus to employees and minimize harm caused by the spread of the virus to the overall activities of the facility. We have given an in-depth briefing and restricted access of third parties. We measure body temperature of our employees on a daily basis before they proceed to their shift work. <br>\n<br>\nNANOLEK stays in touch continuously, and all departments are fully involved in their daily duties: research, production and logistics departments. We have fulfilled and continue to fulfil all our contractual obligations. <br>\n<br>\nBesides, we are constantly doing the media monitoring and follow the latest news related to research on coronavirus disease, emergence of new tests and treatment options.<br>\n<br>\nPlease do not hesitate to contact us should you have any questions or require any further information. We always stay in touch.<br>\n<br>\nYours sincerely, management of NANOLEK<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/052/DJI_0024.jpg"},{"tag":"COMPANY NEWS","title":"A NANOLEK employee becomes the best player of the football tournament in Orichi","date":"25.02.2020","desc":"","link":"/en/news/companynews/a-nanolek-employee-becomes-the-best-player-of-the-football-tournament-in-orichi/","inner_date":"25.02.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>On the eve of the Defender of the Fatherland Day, the NANOLEK corporate football team competed for the title of best with combined teams from Strizhi, Mirny, Orichi, and Pustoshi villages.<br>\n<br>\nMinifootball competitions were held on February 22 in the village of Orichi, Kirov region. During the persistent struggle, FC \"BMK\" (our football team was named so) managed to take an honorable third place, and one of its members - Vladimir Protasov, an expert for closure systems at the biotech drug facility, was given a number one ranking in the tournament! FC \"BMK\" took as a trophy the winning cup, the diploma, and Vladimir was awarded a special prize by the contest organizers.<br>\n<br>\nWe thank our competitors for their sharp and high-quality game, expertise and enthusiasm. See you again on the sports field of battle!<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/6f2/3903da5c_4ce2_4267_9566_0c7ddb117c2d.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEKblog: Alexey Malakhov, investment manager, about investments, risks and a bitcoin","date":"19.02.2020","desc":"","link":"/en/news/companynews/nanolekblog-alexey-malakhov-investment-manager-about-investments-risks-and-a-bitcoin/","inner_date":"19.02.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Investment is a term that is familiar to many of us, but most people perceive it as something complex and mysterious. This is also evidenced by official statistics, according to which only about 2% of the Russian population invest their savings in the stock and bond markets, currency and money markets. <br>\n<br>\nTens of millions of our compatriots open deposit accounts in banks. Of course, deposit accounts can also be called investments: deposit accounts are considered to be absolutely risk-free investments, and return on investment is rarely much higher than inflation. <br>\n<br>\nOn February 7, 2020, at its first meeting in 2020, the key interest rate was lowered by the Central Bank of the Russian Federation for the sixth time in a row and amounted to 6%. The REPO auction minimum interest rate of the Bank of Russia for a period of one week or the maximum interest rate at deposit auctions of the Bank of Russia for a period of one week are set equal to this key rate. <br>\n<br>\nTo paraphrase it in simple terms, this is the interest rate at which the Central Bank is ready to extend funds to commercial banks. If a commercial bank can easily take out a loan fr om the Central Bank at 6%, then it will be ready to get funds from individuals at a more favourable percentage only. This is due to the fact that collection of funds from individuals requires maintenance of a large number of employees to process applications for maintaining deposit accounts. Therefore, the interest rate offered by the majority of banks rarely exceeds 4-5% on deposits with a duration up to 12 months. <br>\n<br>\nAs a result, our compatriots start investing in alternative tools that can generate a greater income. And these investment opportunities are really vast and to the taste of everyone. These may be shares and bonds of companies from different countries, mutual funds, personal investment accounts, and investments in foreign currencies. <br>\n<br>\nHowever, please keep in mind that the main difference from a bank deposit is the existence of a risk. It always has a direct relationship with profitability: the higher the risk, the more you can earn or lose. The most spectacular example of this is bitcoin. One day, this currency can grow by a couple of thousand dollars, and the next day – fall by the same amount, and sometimes even by a larger sum.<br>\n<br>\nThe most important thing I intended to communicate is: never invest in tools that you are not very well versed in, even if they seem very simple to you. A striking example that immediately springs to mind is a novice private trader from Kazan. This man has not just reset his brokerage account to zero for 1 day (almost 5.6 million rubles), but also owed 9.5 million rubles to his broker, while playing with the RUB/USD currency pair. This is a very instructive story about an individual with no professional educational background who started thinking that he saw earning potential which even highly-experienced traders with the best PCs and systems were not able to recognize. However, life is not a fairy tale. <br>\n<br>\nI highly recommend reading the article covering this story \"Without a lim it\": how a private trader reached a turnover of RUB 42 bln by buying and selling foreign currencies on the foreign exchange\". In the next article I'm going to elaborate on this case and tell you how to avoid such a situation.<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bd6/Aleksey-Malakhov-ENG.jpg"},{"tag":"COMPANY NEWS","title":"Evgeniy Barinov - speaker at the Forum of Chief Financial Officers - 2020 \"CFO of the future: partner, mentor, strategist\"","date":"13.02.2020","desc":"","link":"/en/news/companynews/evgeniy-barinov-speaker-at-the-forum-of-chief-financial-officers-2020-cfo-of-the-future-partner-ment/","inner_date":"13.02.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Evgeniy Barinov, Deputy CEO for Finance and Digital Technologies at NANOLEK, took part in the Forum of Chief Financial Officers - 2020 \"CFO of the future: partner, mentor, strategist\" organized by RBK media group.<br>\n<br>\nThe forum brought together the heads of financial departments working with major Russian and international companies. The forum participants shared with their peers experience in financial management and ways of how to improve their functionality for better efficiency amidst the rapid development of a business environment.<br>\n<br>\nThere is no doubt that the classic CFO duties should be backed up with new tools in order for the company to be successful and reach a new level of efficiency. Today, CFO is a business partner who sets new goals, implements digital technologies, and trains colleagues in new skills.<br>\n<br>\nEvgeniy opened the third session of the forum, which was devoted to the role of CFO in the digital era. He provided a clear evidence of what changes are taking place in his occupation field by personal example: digitalization becomes an integral part of the functionality in a rapidly changing reality; for the next 3-4 years, we are planning to develop a digital transformation strategy, search for in-house innovations as part of automation, monitor the organization chart and participate in external accelerators.<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/80b/2I8A1330.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK Is Now a Partner of the Russian Association of Oncologists","date":"06.02.2020","desc":"","link":"/en/news/companynews/nanolek-is-now-a-partner-of-the-russian-association-of-oncologists/","inner_date":"06.02.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>The primary task of the Association is to bring together oncologists who conduct practical activities, improve treatment methods, implement them, and pay particular attention to the prevention of cancer and timely diagnosis. The union also includes theoretical experts involved in scientific research and education in this sphere.<br>\n<br>\nAccording to statistics, cancer mortality today is in second place. Still, thanks to the joint efforts, together we can make a significant contribution to this fight, expand patients' access to effective therapy, and improve the quality of life and its duration. <br>\n<br>\nNANOLEK will take an active part in the work of the Association, since the oncological direction, along with the vaccine, is one of the focal points for the company today. NANOLEK is actively developing a portfolio of medicines for the treatment of cancer, both in partnership with major international companies and through its developments.<br>\n<br>\nThus, in October 2019, NANOLEK and the Janssen company announced the localization of the production of the medicine called Darzalex® (daratumumab) in Russia. This medication is used in the treatment of multiple myeloma. <br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a7b/AOR-770-400.png"},{"tag":"COMPANY NEWS","title":"NANOLEK - a partner of the ping pong tournament","date":"03.02.2020","desc":"","link":"/en/news/companynews/nanolek-a-partner-of-the-ping-pong-tournament/","inner_date":"03.02.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tOn February 1, at a comprehensive secondary school in Levintsy village of the Kirov Region, a ping pong tournament was held with the help of a great supporter - NANOLEK.\n\nAs many as 18 athletes from Orichi, Mirny, and Levintsy attended the competition and, of course, the BMK NANOLEK team consisting of Artem Burdin (an engineer), Evgeny Vasiliev (an equipment operator for preparing sterile solutions), Vladimir Klygin (a specialist in the control and design group). The tournament was held in a circular system. Our athletes had to spend 14 difficult and intensive matches with each of the participants in the competition.\n\nThe level of skill and sports spirit of the players deserves special attention: they regularly train twice a week with the chief judge of the tournament, a sports teacher of the school Nikolai Alexandrovich Kataev.\n\nAnd now the credits to the winners:\nMen - Sergei Perminov from Orichi, who had not lost a single match, took the first place; - The second place got a tennis player from Levintsy village - Alexei Semenov; - Maxim Shishkin from Orichi won third place.\n\nWomen\n- Nadezhda Novoselova from the village Levintsy took the first place;\n- The second place got Alexandra Maltseva also from village Levintsy; - Anna Tolstogorova from the same settlement got third place.\n\nAt the award ceremony, the Director of the Department of Economic Territory Development NANOLEK Sergey Tolstobrov granted the athletes commemorative letters, medals, and gifts. We are happy to congratulate the winners and wish them to achieve new sports results! \n\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/311/1.jpg"},{"tag":"COMPANY NEWS","title":"Vadim Kalinichenko, Director of the NANOLEK Medical Department, about immunity, vaccines and homo sapiens fighting for the right to have a long life","date":"31.01.2020","desc":"","link":"/en/news/companynews/vadim-kalinichenko-director-of-the-nanolek-medical-department-about-immunity-vaccines-and-homo-sapie/","inner_date":"31.01.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Throughout history, mankind has fought for the right to live happily ever after on this planet. People had to deal with all sorts of challenges such as natural disasters, threats of predators and insects, famine, war, etc.</p>\n<p>But the harshest ordeal is an epidemic that has always been at the top of the list. In the Chronicles of control of epidemics and pandemics, there are pages describing infections that destroyed cities, entire regions, and even civilizations. Outbreaks of infectious diseases caused the most awful horror; people dedicated all their resources to fight them.</p>\n<p>In the beginning, we were completely helpless and one of the main reasons was a lack of knowledge. Over time, different abatement techniques have come along. We have progressed from chasing evil spirits away to the development of recombinant vaccines, antibiotics, and antivirals.</p>\n<p>Why can’t an individual cope with the infection himself? Let us work this out.<br>\nAny microorganism consists of various proteins which our immune system tries to recognize and destroy. Phagocytosis is the first and evolutionary oldest defense mechanism. Phagocytes, border dendritic cells form a widely distributed cellular system throughout the body: skin, intestinal track, mucous secretions in the respiratory tract. When anything appears, which is not marked as «friendly», these cells capture and cleave the object. However, this is not enough to ensure effective fighting.</p>\n<p>One of the drawbacks is that trespasses being found are not memorized, so each time you have to make a fresh start. There is a huge variety of microbial heterologous proteins. In some cases, it is a matter of life and death to make a quick assessment and respond promptly to a threat.</p>\n<p>Therefore, we have lymphocytes, the elite troops, which have special receptors on their surface that identify a particular heterologous protein in a personalized manner. After contacting this protein, some of the lymphocytes transformed into a plant for producing antibodies that destroy the intruder or evolves killer cells; the other part becomes memory immune cells so that the next penetration of the same antigen will be instantly detected and eliminated.</p>\n<p>This scenario does not describe all the victories of our body. Why? If we don’t discuss disease states that lead to reduced immunity, the answer to this question can be found in the desire of microorganisms to live. To overcome our body’s defense mechanism, these foreign invaders have also learned to adapt and fight. Some examples of creating such protection are quite admirable. In these cases, an individual cannot cope without external assistance.</p>\n<p>Currently, vaccines are one of the most powerful weapons in the arsenal of homo sapiens. It is precisely through them that we defeated such terrible diseases as smallpox, poliomyelitis, rabies, measles, etc.</p>\n<p>Principle of vaccine is quite simple. Such medication contains a weakened or killed pathogenic microorganism and its proteins in some cases, which can cause an immune response. After the introduction of the vaccine to the body, the same process described above takes place and immunity is well suited to respond from this point.</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/080/Vadim.jpg"},{"tag":"COMPANY NEWS","title":"This is a typical day in the life of our colleague: Irina Chernitsyna, Warehouse Manager of NANOLEK Biomedical Facility","date":"28.01.2020","desc":"","link":"/en/news/companynews/this-is-a-typical-day-in-the-life-of-our-colleague-irina-chernitsyna-warehouse-manager-of-nanolek-bi/","inner_date":"28.01.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Do you love your work the way we do? When you work with joy, you like to share your impressions with everyone. Therefore, we decided to tell you the way our working days are being developed and posted a rubric “This is a typical day in the life of our colleague\". Today, the main character is Irina Chernitsyna, Warehouse Manager of NANOLEK Biomedical Facility. She is cheerful and benevolent, but at the same time, strict and responsible. Irina is one of those managers who won't allow you to fool around.<br>\n<br>\nMake yourselves comfortable, we will spend a day with Irina: from sunrise right through to sunset of working responsibilities. So...<br>\n“The morning begins in the warehouse at 8 am with a 5-minute briefing with the staff to discuss plans for the day. At the same time, I hold a pre-shift occupational health and safety briefing. In addition, it is necessary to walk round the “possession”: inspect equipment, racks, cold warehouses, ensure everything is functioning properly. If necessary, I immediately take steps to fix any failures.<br>\n<br>\nI get to my office desk at about 8:30 and start planning business hours specifically. I believe that the warehouse should be run like clockwork, without fails, smoothly and efficiently. I do my best to reach the goal. A capable manager is not the one who wants to be in control and/or to do the job by oneself, but someone who skillfully distributes it for the staff members.<br>\n<br>\nTime flies during working hours, and soon enough, it is lunch break. During lunch, you can chat about unrelated matters with your colleagues: about life, children, news, and hobbies. After lunch, time passes even faster: Before you know it, it's time to go home.<br>\n<br>\nMy husband and children are waiting for me at home. I help my children with their homework, listen to funny (and not so funny) stories that happened during the day, do the cooking ... In addition, I go to the swimming pool a couple of times a week (it alleviates stress, by the way), and read some professional books and belles-letters. Well, sometimes I wonder, why is there only 24 hours in a day? I realize that planning of working hours and family life is “be-all and end-all.”<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/afa/2.png"},{"tag":"COMPANY NEWS","title":"NANOLEKblog: Elena Stukun, Director of NANOLEK Sales Department, speaks out on the productive work, factors of success and an ideal sales department employee","date":"22.01.2020","desc":"","link":"/en/news/companynews/nanolekblog-elena-stukun-director-of-nanolek-sales-department-speaks-out-on-the-productive-work-fact/","inner_date":"22.01.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t First, productive work is not possible, without the coordinated action of the department staff, which can be represented as a clockwork: all are interconnected; the success of tasks and goals is excellent cross-functional work.\n</p>\n<p>\n</p>\n<p>\n\t An employee of the sales department always strives for balance, taking into account the pressure of the external and internal environment. Such an employee is both the face of the company and its internal client. His main task is to create a need in a formless market, especially when it comes to innovative products.\n</p>\n<p>\n\t What is it like to be a sales manager? Of course, for a female leader, at first glance, it should be more challenging to combine family life and career because of emotionality and the idea of us as a \"weak\" area. But, in this case, the main thing is to understand that emotions and weakness are only brief moments. They recede into the background when you strive for the goal and lead your colleagues.\n</p>\n<p>\n <br>\n</p>\n<blockquote>\n\t<p>\n\t\tA lifehack: I try not to take work home; I learned this lesson when I was an attending physician. Everyone knows that there is always no time to fill out case reports. Hence, there is a great temptation to take some work with you. In my opinion, this is not an option. I try to use all the slightest free time intervals for work: between meetings, before the meeting, and on the plane. Today, electronic devices allow you to check email, respond promptly in instant messengers, and stay in touch regularly.\n\t</p>\n</blockquote>\n<p>\n\t I believe that the main achievement of this year is that the market started talking about the team of the NANOLEK sales department. Our partners and customers see significant positive changes that have occurred over the current year. When working with us, confidence, and a transparent order of relations with customers are pointed out.\n</p>\n <br>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e4e/NANOLEK_.jpg"},{"tag":"COMPANY NEWS","title":"Focus on Immunological prophylaxis. Vladimir Khristenko, speaker at the Gaidar Forum","date":"16.01.2020","desc":"","link":"/en/news/companynews/focus-on-immunological-prophylaxis-vladimir-khristenko-speaker-at-the-gaidar-forum/","inner_date":"16.01.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Passionate debates on hot topics continue at the Gaidar Forum. Vladimir Khristenko, President of NANOLEK, participated in the discussion on Immunological Prophylaxis: Development Prospects for 2035.\n</p>\n<p>\n\t This topic has been raised for quite a long time at various specialised venues and passionately discussed by experts from various authorities. The most efficient prophylaxis of various diseases, including lethal, is vaccination, it is a well-known fact. It becomes even more important in the context of implementation of demographical policy, ensuring biological safety in the modern world and increasing population’s expectancy of healthy life.\n</p>\n<p>\n\t What challenges are faced by the community and what tasks are to be resolved to use the existing achievements more efficiently? How to implement the immunisation concept, taking into account the prospects of vaccination calendar planning? Is vaccination supply planning possible in the long-term? Those and many more questions have been discussed by gathering experts.\n</p>\n<p>\n\t Vladimir Khristenko expressed his point of view and shared his vision of existing problem solving:\n</p>\n<p>\n\t “Both the Russian healthcare system and National Vaccination Schedule develop actively, this should be admitted: previously non-existent vaccines (e.g. pneumococcal disease) appear in the calendar, combined vaccines start to be used, budget is growing. Over the last several years it has increased from RUR 8 to 22, positive shifts are obvious.\n</p>\n<p>\n\t On the other part, there are some aspects that restrain the industry from development. I would like to switch the most important thesis. Most of various support programs could be changed by the only one: guarantee of the National Vaccination Schedule development and guarantee of vaccine procurement within the framework of developing National Vaccination Schedule.\n</p>\n<p>\n\t Here is why. Time is of essence in our industry. The project for inactivated poliomyelitis vaccine localisation was launched in 2012. In 2017, when we prepared a pharmaceutical form, a problem known to everyone arisen, it was a global deficit of poliomyelitis vaccine. Thanks to the existing pharmaceutical form, we were able to fix this problem quite quickly.\n</p>\n<p>\n\t Last year we entered into agreement with the Chumakov Institute (that develops a full-cycle poliomyelitis vaccine) to launch a full-cycle production in 2022 in Russia and enter the WHO market in 2027. It will take 10 years from the project launching to full-cycle production, 15 years until export is started.\n</p>\n<p>\n\t We need guarantees of inclusion of a vaccine in the National Vaccination Schedule in a certain year. In 2019, NANOLEK entered into a range of agreements (with GSK for varicella vaccine localisation, with Sanofi for Meningococcal disease vaccine localisation, etc.), yet actually we have no idea of when these vaccines would be included in the National Vaccination Schedule. The most awful is that by the end of this work, unfortunately, there is no guarantees that the product to be produced will be demanded.\n</p>\n<p>\n\t Let us consider Rospotrebnadzor’s official figures: economic losses from three vaccine manageable infections, i.e. varicella, rotavirus and meningococcus, last year totalled to RUR 53 bn. The budget of the National Vaccination Schedule totals to RUR 23 bn.\n</p>\n<p>\n\t For example, given the cervical cancer sickness statistics, it is clear that this malignancy is the main cause for death of women at the age of 30 to 39. The question is what we wait for to include this vaccine in the National Vaccination Schedule.\n</p>\n<p>\n\t Therefore, we are ready as manufacturers, we have vision and offers. Obviously, a huge work is needed to achieve this goal: epidemiologists’ forecast for growth in incidence rate, the state is to perform work for procurement price planning, data on childbirth in 5 years are needed, the above requires huge preliminary work from in terms of forecasting. Similarly, our work requires huge preparation as well, huge contribution of time, resources and, first and foremost, intellectual capital. Therefore, I would like to invite all attending experts to return to this question repeatedly.\n</p>\n<p>\n\t \n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/a31/1.jpg"},{"tag":"COMPANY NEWS","title":"Maksim Stetsyuk is a speaker in the course of the discussion Cell and Genetic Technologies Development in Russia at the Gaidar Forum","date":"15.01.2020","desc":"","link":"/en/news/companynews/maksim-stetsyuk-is-a-speaker-in-the-course-of-the-discussion-cell-and-genetic-technologies-developme/","inner_date":"15.01.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Today, the XIth Gaidar Forum - an expert international scientific and practical conference in the area of Economy attended by world’s leading scientists and politicians, representatives of financial circles and global business elite - has commenced its work in Moscow.\n</p>\n<p>\n\t The key topic of the Forum Russia and World: New Decade Challenges covers issues relating to the next decade challenges, economic development, healthcare, digital revolution and forefront of modern research in other areas.\n</p>\n<p>\n\t Maksim Stetsyuk, executive director of NANOLEK, participated in the panel discussion Cell and Genetic Technologies Development devoted to detailed consideration of the problem and introduction to the practice and application of innovative gene-therapy and cell technologies in Russia.\n</p>\n<p>\n\t Executive director of NANOLEK shared his opinion: “Recently, there have been a lot of discussions relating to discovery of new products that have not yet been invented in the world.\n</p>\n<p>\n\t The answer is where joint interests of scientific circles and medical community and business overlap. I am optimistic about the trend for development of discussion venues where regulators, medical experts, patient organisations, commercial sector may meet.\n</p>\n<p>\n\t Creation of an innovative product is the basis for early diagnostics development, which result in accumulating expertise by the medical community, expanding young scientists’ knowledge base, development of educational process at institutions and formation of well-prepared young human resources for business. This promising link is to be developed.”\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/821/Bezymyannyy2222.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK was ranked first in the category Fast Growing Major Companies rating TEKHUSPEKH 2019","date":"15.01.2020","desc":"","link":"/en/news/companynews/nanolek-was-ranked-first-in-the-category-fast-growing-major-companies-rating-tekhuspekh-2019/","inner_date":"15.01.2020","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t TekhUspekh is the most influential rating of Russian companies that demonstrate fast growth, dynamic turnover and innovative technologies in their work.\n</p>\n<p>\n\t Annual TekhUspekh rating has been organised by the Russian Venture Company (RVC) in cooperation with the Association of Innovative Regions of Russia (AIRR) and other partners to evaluate innovative business potential of rapidly developing hi-tech companies that have a high leadership potential both at the Russian and global market.\n</p>\n<p>\n\t The main criteria for evaluation of the level of success and technological effectiveness of companies are the size of a company, rate of growth in companies’ income, innovativeness and product novelty, intellectual property owned by the company, investments in innovation projects and acquiring of hi-tech, the level of demand in products at export markets.\n</p>\n<p>\n\t We would like to thank the expert council for high rating assigned to NANOLEK’s activities. The highest position in TekhUspekh rating is a great honour, we head on to further development of national pharmaceutics.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/515/1031_b.jpg"},{"tag":"COMPANY NEWS","title":"Merry Christmas and happy New Year","date":"31.12.2019","desc":"","link":"/en/news/companynews/merry-christmas-and-happy-new-year/","inner_date":"31.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tWe wish you a Merry Christmas and a happy New Year!<br>\n <br>\n May miracles happen and all your dreams will come true!<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/fc3/2020_eng.gif"},{"tag":"COMPANY NEWS","title":"The First Step of Pentaxim® Vaccine Delivery Under a 2-year Contract Successfully Completed: a New Era in Fighting Against Dangerous Infections","date":"19.12.2019","desc":"","link":"/en/news/companynews/the-first-step-of-pentaxim-vaccine-delivery-under-a-2-year-contract-successfully-completed-a-new-era/","inner_date":"19.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\tSanofi and Nanolek announced successful Completion of Phase 1 of supply of the Pentaxim® vaccine manufactured by the Nanolek plant under a two-year state contract (for 2019-2020). In total, 3.5 million doses of the vaccine were delivered in 2019 - this helped protect about one million children from five dangerous infections: tetanus, pertussis, diphtheria, poliomyelitis, and Hemophilus influenza type b. It is expected that a total of about seven million doses is expected to be delivered by the end of 2020.\n</p>\n<p>\n\t In May 2019, the Russian Ministry of Health, for the first time, concluded a two-year state contract for the supply of the Pentaxim® vaccine for the needs of the National Vaccination Schedule. This decision of the government customer to determine the long-term need for vaccines allowed Sanofi and Nanolek to plan for vaccine production volumes considering the duration of its production cycle (up to 12 months), as well as to ensure timely and regular vaccine deliveries.\n</p>\n<p>\n\t Further concluding long-term state contracts will allow both the state customer and business to optimally organize the planning, production, logistics, and immunization mechanisms so that all Russian children could be protected from dangerous infections in a timely manner.\n</p>\n<p>\n\t Multicomponent vaccines are a modern and essential tool to increase vaccination coverage, as well as the timeliness of NVS implementation. The long-term partnership between Sanofi and Nanolek intensifies the protection of Russian children from severe infectious diseases.\n</p>\n<p>\n\t Guillaume Oshalter, General Manager, Sanofi Pasteur Russia, and Belarus, noted: \"Vaccination is the only reliable method to avoid many serious contagious diseases, as well as subsequent complications. Nowadays, vaccination is carried out for kids around the world, which annually saves about three million children's lives. Reducing vaccination coverage leads to the return of infections that seemed already completely defeated. To improve the situation, it is necessary, in particular, to work on the development of Russian pharmaceutical production and vaccination policies, including ensuring greater availability of drugs to as many Russians as possible. For more than four years, Sanofi and Nanolek have been jointly contributing to the fight against infectious diseases, and a lot has been done over this time. We are pleased that our partnership is developing, and thanks to it, more and more Russian children are protected against infections with modern, high-quality, and safe vaccines.\"\n</p>\n<p>\n\t Vladimir Khristenko, President of Nanolek, comments: \"The use of combined vaccines, in particular, those containing an inactivated polio component (IPV), will make it possible to save on the prevented costs of diseases significantly. Besides, switching from monovaccines to combined ones can significantly reduce the indirect cost of vaccination. Cooperation with Sanofi helps us to introduce the most advanced vaccine production technologies in the Russian Federation and to use more effective vaccination schemes in Russia that are consistent with WHO recommendations.\"\n</p>\n<p>\n\t An agreement between Nanolek and Sanofi on the production of a five-component combined vaccine for children in Russia was signed in May 2015 at the Economic Forum in St. Petersburg with the participation of the Minister of Industry and Trade of the Russian Federation, the Governor of the Kirov Region and the Chairman of the Board of RUSNANO.\n</p>\n<p>\n\t In 2016, the first stage of localization of vaccine production in Russia was completed, and the transfer of the vaccine quality control system was carried out. From 2016 up to the present, the company has produced five million doses of vaccine. Since 2017, the vaccine has been successfully supplied as part of the National Schedule of Preventive Vaccinations.\n</p>\n<p>\n\t The use of combined vaccines can decrease the number of injections, particularly for children in their first two years of living, as well as the costs of administration, storage, and turnover of immunobiological medical drugs, while increasing vaccination coverage.\n</p>\n<p>\n\t About Pentaxim® Vaccine\n</p>\n<p>\n\t · Pentaxim vaccine<sup>® </sup>designed to prevent five infections - diphtheria, tetanus, pertussis, poliomyelitis, and infections caused by Haemophilus influenza type b.\n</p>\n<p>\n\t · Pentaxim <sup>®</sup>, for the first time, was registered in 1997 in Sweden. In domestic health practice, the vaccine has been used since 2008.\n</p>\n<p>\n\t · Pentaxim vaccine <sup>® </sup>dosing regimen corresponds to the National Schedule of Vaccinations: vaccination is carried out at the age of 3, 4.5, and 6 months; revaccination - at 18 months. In this case, the use of the Pentaxim Vaccine<sup>® </sup>does not violate the timing of immunization against other infections in the framework of the National Vaccination Schedule.\n</p>\n<p>\n\t · Application experience in Russia and numerous clinical studies<a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9F%D1%80%D0%B5%D1%81%D1%81-%D1%80%D0%B5%D0%BB%D0%B8%D0%B7_%D0%A3%D1%81%D0%BF%D0%B5%D1%88%D0%BD%D0%BE%D0%B5%20%D0%B7%D0%B0%D0%B2%D0%B5%D1%80%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BF%D0%B5%D1%80%D0%B2%D0%BE%D0%B9%20%D0%BF%D0%BE%D1%81%D1%82%D0%B0%D0%B2%D0%BA%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%9F%D0%B5%D0%BD%D1%82%D0%B0%D0%BA%D1%81%D0%B8%D0%BC_en.docx#_ftn1\"><sup><sup>[1]</sup></sup></a>conducted by leading medical institutions of the country (SSC Institute of Immunology FMBA, Research Institute for Children's Infections FMBA, Scientific Centre for Children's Health RAMS) have proved the high efficiency and safety of the drug in healthy children and children with differences in health status (e.g., neurological, allergic diseases, immunodeficiencies of different genesis, and born prematurely).\n</p>\n<p>\n\t · Produced by NANOLEK since 2017, Pentaxim vaccine <sup>®</sup> has been supplied for the needs of the National Preventive Vaccination Schedule.\n</p>\n<p>\n\t About Sanofi\n</p>\n<p>\n\t Sanofi is a global biopharmaceutical company whose mission is to provide support to those who face various health problems.\n</p>\n<p>\n\t With the help of our vaccines, we strive to protect people from diseases, and our drugs help to ease the course of many diseases and improve the quality of life for patients with rare and common chronic diseases.\n</p>\n<p>\n\t Over 100,000 Sanofi employees in 100 countries around the world work every day to turn scientific innovation into particular healthcare solutions.\n</p>\n<p>\n\t About Sanofi Pasteur\n</p>\n<p>\n\t Sanofi Pasteur - a division of the Sanofi Group of Companies - is a world leader in the production and development of human vaccines. A wide variety of vaccines on the global market includes drugs for the prevention of more than fifteen viral and bacterial diseases. Every year, the company produces more than one billion doses of vaccines to immunize over 500 million people worldwide. For more than 100 years of history, the company's mission has remained unchanged and is aimed at protecting life and defending human health from infectious diseases. Every day, Sanofi Pasteur invests in research and development of more than one million euros.\n</p>\n<p>\n\t The following vaccines have been registered in Russia: mono - and combined vaccines for the prevention of dangerous children and adult infections - diphtheria, tetanus, pertussis, poliomyelitis, hemophilic infection type b (Imovax Polio®, Pentaxim®, Adasel), influenza (Vaxigrip), viral hepatitis A (Avaxim 160, Avaxim 80 ), and meningococcal infection (Menactra).\n</p>\n<p>\n\t About Nanolek\n</p>\n<p>\n\t Nanolek is a modern fast-growing Russian biopharmaceutical company with its own high-tech full-cycle production according to GMP standards, which specializes in the production of import-substituting and innovative drugs, both of its own design and is created with the engagement of international partners, with a focus on the prevention and treatment of socially meaningful diseases. Today, the company is one of the leaders in the production of paediatric vaccines in the Russian Federation.\n</p>\n<p>\n\t The diversified product portfolio of Nanolek preparations is presented in the following therapeutic areas: vaccines, drugs for HIV treatment, cancer, etc. The company has unique knowledge in the field of technology transfer in partnerships with leading global pharmaceutical companies (e.g., Merck, Sanofi, Novartis, Egis, Celltrion, Riemser, etc.).\n</p>\n<p>\n\t \n</p>\n<p>\n\t \n</p>\n <br>\n <br>\n<hr align=\"left\" size=\"1\" width=\"33%\">\n<p>\n <a href=\"file:///C:/Users/t.zaytseva/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/QLCGETP9/%D0%9F%D1%80%D0%B5%D1%81%D1%81-%D1%80%D0%B5%D0%BB%D0%B8%D0%B7_%D0%A3%D1%81%D0%BF%D0%B5%D1%88%D0%BD%D0%BE%D0%B5%20%D0%B7%D0%B0%D0%B2%D0%B5%D1%80%D1%88%D0%B5%D0%BD%D0%B8%D0%B5%20%D0%BF%D0%B5%D1%80%D0%B2%D0%BE%D0%B9%20%D0%BF%D0%BE%D1%81%D1%82%D0%B0%D0%B2%D0%BA%D0%B8%20%D0%B2%D0%B0%D0%BA%D1%86%D0%B8%D0%BD%D1%8B%20%D0%9F%D0%B5%D0%BD%D1%82%D0%B0%D0%BA%D1%81%D0%B8%D0%BC_en.docx#_ftnref1\">[1]</a> D.A. Novikova, L.S. Namazova-Baranova, A.G. Gayvoronskaya, M.I. Broeva, M.V. Fedoseenko \"Safety Assessment of the Use of Pentavacine in Premature Infants: Experience of the Centre for Family Vaccine Prevention”, Issues of Modern Pediatrics /2015/Volume 14/No. 3\n</p>\n <br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/570/btp_10.jpg"},{"tag":"COMPANY NEWS","title":"The Governor of the Kirov Region Igor Vasiliev Awards the Employees of NANOLEK","date":"12.12.2019","desc":"","link":"/en/news/companynews/the-governor-of-the-kirov-region-igor-vasiliev-awards-the-employees-of-nanolek/","inner_date":"12.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t At the NANOLEK biomedical complex in the Kirov Region, a grand event dedicated to summing up the results of the year was held.\n</p>\n<p>\n\t The guests of honour of the event were: Governor of the Kirov Region Igor Vasiliev, Chairman of the Government of the Kirov Region Alexander Churin, First Deputy Chairman of the Government of the Kirov Region Dmitry Kurdyumov, and Minister of Economic Development of the Kirov Region Natalia Kryazheva.\n</p>\n<p>\n\t Igor Vasiliev awarded the NANOLEK employees for their exceptional contribution to the implementation of projects so much crucial for the region:\n</p>\n<p>\n\t ·<b>Svetlana Efimova, Deputy General Director for Operations and Partner Relations</b> was awarded for the effective administration of production projects for the full cycle of Glucophage and Concor pharmaceutical products of Merck and successful coordination of interaction with partners;\n</p>\n<p>\n\t ·<b>Eduard Kuzmin, Head of Production of Solid Dosage Forms</b> got his award for active participation in the launch of the production of the drug named Concor;\n</p>\n<p>\n\t ·<b>Maxim Kapaev, a chief mechanic,</b> received his award for the implementation of a project to modernize the lines of solid and liquid dosage forms under the state program \"Marking of Medicines\".\n</p>\n<p>\n\t The Governor expressed his appreciation to the staff and management of the company for their active participation in the life of the region and support of the territory infrastructure.\n</p>\n<p>\n\t Summing up the results of the year, the NANOLEK executive managers told the team about the company's strategy, described the main operational tasks, and shared their plans for long-term development.\n</p>\n<p>\n\t Today, the results of the year that is now ending are summed up, and plans are outlined. We thank the Government of the Kirov Region for comprehensive support; our partners - for trust, and our colleagues - for conscientious work!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/439/DSCF4090.JPG"},{"tag":"COMPANY NEWS","title":"Merck joins forces with NANOLEK to launch a production facility in Russia that is expected to produce the most commonly used drugs for cardiovascular diseases","date":"11.12.2019","desc":"","link":"/en/news/companynews/merck-joins-forces-with-nanolek-to-launch-a-production-facility-in-russia-that-is-expected-to-produc/","inner_date":"11.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Merck (Darmstadt, Germany), a leading scientific and technological company, and the Russian biopharmaceutical company NANOLEK have launched the full-cycle production to manufacture one of the key medicines used in treating arterial hypertension, ischemic heart disease and congestive heart failure. The drug will be produced at the facility of NANOLEK in Kirov region in full compliance with GMP standards.\n</p>\n<p>\n\t To date, more than 110 employees are involved in the drug production process in Kirov. It has taken 4 years on the whole to set up a full-cycle production, technology transfer lasted for 2 years. The agreement between the companies is planned as long-term cooperation. The drug produced has been on the list of vital and essential medicines since 2010. The annual planned output of the pharmaceutical drug, when full throughput is reached in 2021, will amount to 650-700 million tablets. Setting up a local, Russian-based production of a foreign drug is a big step towards improving the security of the drug supply chain in Russia and accessibility for the patient.\n</p>\n<p>\n\t “Today in Russia there are modern production sites that meet all international requirements and standards and offer growth opportunities both for foreign and Russian pharmaceutical providers. Setting up a local, Russian-based production of our second drug in Kirov is an additional benefit of Merck over other manufacturers,” <b>said Matthias Wernicke, CEO of Merck Biopharma in Russia and the CIS.</b>\n</p>\n<p>\n\t According to the Ministry of Health of the Russian Federation, currently 40% of Russian citizens suffer from hypertension. Arterial hypertension is one of the most common chronic non-specific human diseases, which account for 30% of all deaths, according to data provided by WHO. Reduction in mortality from cardiovascular diseases is one of the objectives in the Pharma 2020 pharmaceutical industry development strategy in Russia.\n</p>\n<p>\n <b>Professor, Doctor of Medical Sciences, Yuri Karpov:</b> “Cardiovascular diseases (CVDs) are the leading global cause of death: more people die annually from CVDs than from any other cause”. An estimated 17.9 million people died from CVDs in 2016, representing 31% of all global deaths. Of these deaths, 85% are due to heart attack and stroke”.\n</p>\n<p>\n <b>Vladimir Khristenko, President of NANOLEK:</b> “We are very pleased about our long and successful cooperation with Merck, one of the largest scientific and technological companies in the world. We are confident that our cooperation efforts will help Russian patients get access to the medication with high-quality original drugs produced in Russia. An additional production line launched at the facility in Kirov is expected to boost production several times in order to sell drugs even to more people in need of them”.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/4f7/40411889_1287_45a5_a581_982ce783a8e1.jpg"},{"tag":"COMPANY NEWS","title":"Anton Pak has been elected Chairman of the Board of NANOLEK Holding","date":"09.12.2019","desc":"","link":"/en/news/companynews/anton-pak-has-been-elected-chairman-of-the-board-of-nanolek-holding/","inner_date":"09.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Anton Petrovich Pak has joined the new Board of NANOLEK Holding as a Chairman of the Board. Anton Pak’s key responsibilities will include acting on behalf and protecting interests of company’s investors in the course of decision-making relating to matters referred to the competence of the Board, first of all, within the framework of implementation of NANOLEK’s development strategy and corporate finance management.\n</p>\n<p>\n\t Anton Petrovich graduated from MGIMO (the Moscow State Institute of International Relations), London Business School, School of Law of the Northwestern University.\n</p>\n<p>\n\t Currently, Anton Pak takes a position of the managing partner of K2 Group private equity fund, specialising in the search for prospective investment projects, structuring and completion of transactions that provide for investors’ involvement therein; ensures operational monitoring of supported projects, including participation in meetings of boards/meetings of shareholders of design companies. \n</p>\n<p>\n\t Anton Pak’s previous experience as the general director of the regional investment fund North Caucasus Development Corporation, OJSC includes successful resolution of tasks that involve selection and support of commercially viable projects and attracting private investors thereto as well as building a risk management system for design companies. Anton Pak has previously worked as a senior manager in banking sector (Rosbank, IFC, etc.).\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/7d7/pak.jpg"},{"tag":"COMPANY NEWS","title":"Maxim Stetsyuk takes part in the National Industrial Forum","date":"09.12.2019","desc":"","link":"/en/news/companynews/maxim-stetsyuk-takes-part-in-the-national-industrial-forum/","inner_date":"09.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Today, Moscow became the venue for the National Industrial Forum focused on \"Industry and national development goals\".\n</p>\n<p>\n\t The forum aims at setting up a dialogue between businesses and the government, shaping a realistic industrial agenda with regard to state priorities and business needs. The bottomline is to get targeted support for projects of industrial companies, create proposals to the Russian government in order to achieve development goals in the Russian Federation.\n</p>\n<p>\n <b>Maxim Stetsyuk, CEO of NANOLEK,</b> took part in the panel discussion \"Pharmaceutical and medical industry\" to discuss various topics with other participants: development of the \"Pharma-2030\" strategy, reinforcing export support, topical issues in socially significant diseases, current state support for industrial projects.\n</p>\n<blockquote>\n\t<p>\n\t\t “Production of vaccines is a challenging business and intensive in terms of investments that pay off nor earlier than in 7, and on average in 10 years. Over the past 3-4 years, we have implemented joint projects with our foreign partner companies as part of \"Pharma-2020\" strategy. And these practical steps are extremely important since they made it possible to import modern multicomponent vaccines to Russia. Besides, we, as a local manufacturer, have gained priceless experience in the production of such vaccines at the level of global standards.\n\t</p>\n\t<p>\n\t\t If it comes to discussing the \"Pharma-2030\" strategy, awareness of manufacturers of what vaccines will be needed in the coming years is an extremely important for state support of the vaccine track. In this case the local manufacturer, particularly NANOLEK, will assure to do its best to provide the Ministry of Health of Russia with vaccines required.\"\n\t</p>\n</blockquote>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d89/1.jpg"},{"tag":"COMPANY NEWS","title":"Mikhail Nekrasov - A Nominee of the Annual Prize “Person of the Year 2019. Large Business and Social Sector”","date":"06.12.2019","desc":"","link":"/en/news/companynews/mikhail-nekrasov-a-nominee-of-the-annual-prize-person-of-the-year-2019-large-business-and-social-sec/","inner_date":"06.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Mikhail Nekrasov, General Director of NANOLEK, is a nominee of the Annual Prize “Person of the Year 2019. Large Business and Social Sector” in the nomination “Production Man of the Year”.\n</p>\n<p>\n\t Today, in Kirov, the award ceremony was held, organized by the Business Class magazine. The primary goal of the event is to reward the best leaders of the region in all areas. Remarkably, the Award ceremony is held with the support of the Kirov Region Government.\n</p>\n<p>\n\t An expert jury evaluated the candidates according to specific criteria: tax deductions, headcount, employee salary level, social activity, representation outside the region, and company achievements for the year.\n</p>\n<p>\n <br>\n\t We thank the organizers and the jury for the high appreciation of the NANOLEK activities.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/158/Bezymyannyy.jpg"},{"tag":"COMPANY NEWS","title":"The International Scientific and Practical Forum \"Russian Health Week-2019\"","date":"03.12.2019","desc":"","link":"/en/news/companynews/the-international-scientific-and-practical-forum-russian-health-week-2019-/","inner_date":"03.12.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t This large-scale congress and exhibition event in the healthcare sector will be hosted by the Expoforum Fairgrounds and last until December 6, 2019. The exhibition areas showcase current development trends of domestic and global medicine. More than 80 various events are scheduled: thematic conferences, presentations, exhibitions that will be attended by more than 1,000 exhibitors from 37 countries. \n</p>\n<p>\n\t The PharmMedProm forum is held as part of the \"Russian Health Week\". NANOLEK displays its products at the joint stand of the Ministry of Industry and Trade of the Russian Federation.\n</p>\n<p>\n\t During the visit of the official delegation to the stand, representatives of the company provided Sergey Anatolyevich Tsyb, the First Deputy Minister of Industry and Trade of the Russian Federation, with detailed information about the key company's projects launched in 2019. Thus, in September 2019, NANOLEK signed an agreement on long-term strategic partnership with GSK, a multinational pharmaceutical research company. The first stage of the joint project is a planned transfer of varicella vaccine production technologies to Russia. Production is scheduled to start in 2021.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/80d/73e0d2d8_d5e6_41b0_8ead_14d0b2c1281c.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK speaks about labelling at the Conference \"IT in Healthcare 2019\"","date":"29.11.2019","desc":"","link":"/en/news/companynews/nanolek-speaks-about-labelling-at-the-conference-it-in-healthcare-2019/","inner_date":"29.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On November 28, Moscow hosted the conference \"IT in healthcare 2019\", which brought together various healthcare industry players. The main idea behind the conference is to create a single digital healthcare channel through the integration of IT systems developed by healthcare providers and federal IT systems.\n</p>\n<p>\n\t You certainly know very well that a drug labelling project is currently in full swing as we try to keep you up to date on latest developments in the industry. This year was marked by a lot of meetings, round table discussions, talks that were held at different levels: both at the level of regulatory agencies and major players in the labelling market.\n</p>\n<p>\n\t And this time we also couldn't overlook the specific topic discussed by the medical community and readily accepted the invitation to demonstrate our labelling implementation project at the conference, particularly with regard to the fact that the conference was attended by nearly all members of the supply chain.\n</p>\n<p>\n\t Alexey emphasized that perhaps the most important link in the project implementation process in NANOLEK is a cross-functional team, with a core made up of approx. 7 people. They covered the necessary business segments, such as packaging processes, serialization equipment, qualification and validation, etc. On the whole, the project team consisted of 35 people who got involved as needed.\"\n</p>\n<blockquote>\n\t<p>\n\t\t \"Late last week, we labelled 2550 packages as part of two commercial batches of the drug intended to treat mucopolysaccharidosis type II. We have faced of course various challenges during the work and though we haven't managed to solve all of them so far, solving is already in progress.\n\t</p>\n\t<p>\n\t\t We used a few simple but effective rules in terms of management and thus, in empirical way, achieved the results that we have today.\n\t</p>\n\t<p>\n\t\t Generally speaking, I can give an unequivocal answer to the question \"How do we benefit from labelling as manufacturer?\": We stay protected against counterfeiting and re-launch of drugs to market.\"\n\t</p>\n</blockquote>\n<p>\n\t Well, our discussion is over, however there are still many productive and mutually beneficial meetings that await us in the future.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/106/c97856c1_de38_4154_8885_f3beaca4d281.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK nominated for the \"PRIORITY-PHARMA\" national award","date":"28.11.2019","desc":"","link":"/en/news/companynews/nanolek-nominated-for-the-priority-pharma-national-award/","inner_date":"28.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t NANOLEK has won the prestigious national award \"PRIORITY-PHARMA\".\n</p>\n<p>\n\t The main national award in the field of import substitution and technology transfer \"Priority\" is awarded to providers that have shown the greatest success in import substitution. This year, a record number of applications for award was taken from companies engaged in various economic sectors.\n</p>\n<p>\n\t The goal of the award is to promote active development of import substitution in Russia, strengthen prestige of domestic producers, upswing demand for Russian-made products and technologies.\n</p>\n<p>\n\t During the festive award ceremony, Maxim Stetsyuk, CEO of NANOLEK, thanked the contest organizers for the high rating given to the company's performance:\n</p>\n<p>\n\t \"We have set up a local production facility in Russia to manufacture polio vaccines, but there is still a lot to be done as pharmaceutics is one of the most complex industries. I wish to thank the government of the Kirov region and the Ministry of Industry and Trade of Russia, which provide support in our discoveries.\n</p>\n<p>\n\t I would like to add that we live in a huge country and I suggest that all of us, companies gathered here in this place, funnel motivation to our young people, and demonstrate them by personal examples that today we can make breakthrough discoveries, look for new drugs, and not just localize production plants in Russia.\n</p>\n<p>\n\t We aspire to be competitive and we can boast of having a huge potential and such awards certainly motivate us for further excellence to create something new. Dear colleagues, I wish all of you good luck!\"\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/09e/78318583_2600766716635507_1656575118064746496_o.jpg"},{"tag":"COMPANY NEWS","title":"All-Russian forum \"Public Immunity\" was held in Moscow","date":"27.11.2019","desc":"","link":"/en/news/companynews/all-russian-forum-public-immunity-was-held-in-moscow/","inner_date":"27.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On November 27, Moscow hosted the All-Russian forum \"Public immunity\" which was attended by healthcare leaders on both a national and regional scale, experts from the scientific community and different businesses.\n</p>\n<p>\n\t The forum primarily focuses on the role of immunoprophylaxis in increasing life expectancy of the population, shaping a healthcare culture, advanced vaccine production technologies, opposition to anti-vaxxer movements and many other issues.\n</p>\n<p>\n\t In her welcoming speech, Minister of Health Veronika Skvortsova announced that the Ministry of Health of the Russian Federation is elaborating a strategy for the development of immunoprophylaxis until 2035. The Ministry is going to prioritize stay focused on expanding the national vaccination schedule and extending the preventive vaccination coverage.\n</p>\n<p>\n\t Such a strategy is urgently needed today as public health care includes not only protocol events, but also promotion of a healthy lifestyle, personal responsibility for their health (sports, giving up bad habits), corporate responsibility (launch of voluntary health insurance policies), involvement of media channels in dissemination of information about the need (and most importantly safety) of preventive vaccination.\n</p>\n<p>\n\t Joint efforts of the state and businesses play a crucial role in the fight against vaccine preventable diseases. A proper, well thought-out request requires an accurate response, particularly if the question concerns the preservation of human life and health.\n</p>\n<p>\n\t Vladimir Khristenko, President of NANOLEK, took part in the plenary session \"Immunoprophylaxis as a way to protect public health\" together with representatives of the Ministry of Health, the Russian Academy of Sciences and major players in the commercial market segment.\n</p>\n<p>\n\t Vladimir shared a positive experience of signing state agreements on supplies of inactivated polio vaccines. This has allowed to schedule production processes in advance and in a sustainable way, therefore regular supplies of immunobiological drugs within NCPI (National Schedule of Prophylactic Immunization) will be launched as early as in the first quarter of 2020.\n</p>\n<p>\n <br>\n</p>\n<blockquote>\n\t<p>\n\t\t \"Based on the positive experience, we believe that it is important to go further, to deepen trust of the state and businesses and switch to at least three-year government contracts on supply of vaccines. And there is no need to change the laws.Three-year contracts will make easier the state mechanisms of management, planning, logistics in terms of immunoprophylaxis, and, which is very important, will establish a fixed price for the supplied products during the term of the contract\".\n\t</p>\n</blockquote>\n<p>\n\t In continuation of the discussion day of the \"Public immunity\" forum, Maxim Stetsyuk, CEO of NANOLEK, took part in the panel discussion \"Factors Influencing Public Immunisation Coverage\".\n</p>\n<p>\n\t Healthy lifestyle (HLS) or health care (HC)? Fish or meat? Blogger or conventional mass media?\n</p>\n<p>\n\t Despite the serious issues raised during the discussion, the dialogue turned out to be very informal. The experts sitting in a circle of like-minded people discussed the following topics: immunisation from the point of view of ordinary people, misconceptions and myths in our society, how the medical community may affect the consciousness of an ordinary citizen, role of nutrition in shaping a health care (HC) culture.\n</p>\n<p>\n\t There is no doubt that consistent work is needed to form a clear vision of a healthy lifestyle behaviour. Commonplace truth: giving up bad habits, healthy food, sports - all this will promote a healthy and long life. Joined efforts of physicians, competent media planning for the dissemination of reliable information as well as personal example may help achieve tangible sustainable results in promoting health of the whole nation.\n</p>\n<p>\n\t \"Can a manufacturer form a public opinion and build communication with a wide consumer audience about the vaccination necessity (given the fact that direct advertising of drugs is prohibited by law)?\" Maxim Stetsyuk gave a detailed answer to this question from a perspective of the general discussion topic:\n</p>\n<blockquote>\n\t<p>\n\t\t \"We decided within the company that we need to start with ourselves: we actively use social networks to keep our audience informed about the vaccination expertise abroad, representative statistics, current situation in the Russian medical industry and cover the issues regarding anti-vaccine advocates' community.\n\t</p>\n\t<p>\n\t\t I believe that we need to strengthen trust in physicians using the information realm since a doctor is always the first to shape a right attitude to public vaccination.\n\t</p>\n\t<p>\n\t\t In general, the Russian Ministry of Health has done a lot of work to expand the national vaccination schedule. And I convince all members of my family of the necessity to vaccinate by personal example.\n\t</p>\n\t<p>\n\t\t By the way, about the myths. Domestic vaccines are believed to have poor quality. I as a manufacturer can reassure you: our company has a GMP certificate and is audited by foreign partners at least 1-2 times a month, and there is only one way to pass such inspection: your production chain should be completely free of any malfunctions. I invite everyone of you to visit the NANOLEK plant in the Kirov region to experience it first-hand\".\n\t</p>\n</blockquote>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/4a4/1.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK participates in the VIII forum \"Pharma CFO 2019\"","date":"25.11.2019","desc":"","link":"/en/news/companynews/nanolek-participates-in-the-viii-forum-pharma-cfo-2019/","inner_date":"25.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n</p>\n<p>\n\t Evgeny Barinov, Deputy CEO of NANOLEK for Finance and Digital Technologies, took part in the Eighth forum \"Pharma CFO 2019\", which was held in Moscow on November 21-22, 2019.\n</p>\n<p>\n\t The forum brought together CFO's of the leading providers fr om the pharmaceutical industry only - manufacturers, distributors and pharmacy chains.\n</p>\n<p>\n\t The organizers traditionally conducted a survey among the forum participants and received an interesting summary. The vast majority believe e.g. that a CFO should have diverse experiences in his or her portfolio:\n</p>\n<p>\n\t 58% of respondents said that moving to a pharmaceutical company from other sectors is possible, and 39% believe that such a decision is reasonable on top of all. And only 3% of respondents advocate hiring of professionals with a \"pharma background only\".\n</p>\n<p>\n\t A part of the panel discussion attended by Yevgeny Barinov was dedicated to debates on the pricing procedure for life-saving and essential drugs (LSED), price registration issues, legislation governing management of prices for LSED as well as practice of re-registration of drugs produced and registration of new ones.\n</p>\n<p>\n\t Such meetings are particularly useful when held on a regular basis and attended by representatives of entities at different levels. Figuratively speaking, there is a big boat called \"health\" wh ere several members of the team are sitting. And such meetings specifically help all participants reach an agreement about further steps and direction.\n</p>\n <br>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e32/738d9a51_4bbf_4249_bc15_b767dee45a02-_002_.JPG"},{"tag":"COMPANY NEWS","title":"NANOLEK Launches First Marked Commercial Batch of Medicine","date":"21.11.2019","desc":"","link":"/en/news/companynews/nanolek-launches-first-marked-commercial-batch-of-medicine-/","inner_date":"21.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tOn November 21, 2019, the NANOLEK biomedical complex in the Kirov Region released a marked commercial batch of the drug for the treatment of type II mucopolysaccharidosis, which is included in the list of 12 high-cost nosologies (HCN). <br>\n <br>\n NANOLEK has successfully introduced all the necessary marking hardware and software for production. The stage of active testing of messaging in the drug monitoring system with partners has completed. Thanks to the measures taken, the company managed to start the planned process and release a marked first commercial batch of the orphan drug for the treatment of type II mucopolysaccharidosis (included in 12 HCN) in the amount of 1,664 packs on November 21. <br>\n <br>\n <b>Alexey Ryzhiy, IT Director, NANOLEK: </b><br>\n<blockquote>\n\t<i>\"Today, we successfully exchanged data in the productive circuit of the drug movement monitoring system and marked the product at the factory. This suggests that our production part has been completed and successfully tested; therefore, we are fully prepared for the implementation of this large-scale project. We are at the very beginning of the journey, but the first big step has been taken.<br>\n </i><br>\n\t<i>\n\tToday, we are pleased with the result and the work done, but if you look back, of course, the process was not that smooth, and we faced a number of difficulties. Any IT system may fail even within a single company. In this case, we are dealing with a global project that is simultaneously being implemented in the entire distribution chain in the Russian Federation so that all the processes operate like clockwork - more time and practice are required.<br>\n </i><br>\n\t<i>\n\tI'm glad that the State Duma initiated a stage-by-stage implementation of the mandatory marking process from July 1, 2020; the postponement gives substantial hope for 100 percent preparation of all participants in the process in order to avoid unpleasant outcomes, as a result of which, first of all, the consumer may suffer.\"</i>\n</blockquote>\n <br>\n A pilot drug-marking project in the Russian Federation started on February 1, 2017. From October 1, 2019, the marking of medicinal products for 7 HCN is mandatory.<br>\nAccording to the data provided by the website of the Federal Service for Surveillance in Healthcare, as many as 27 international generic names of medicines of List 7 of HCN have been registered and approved for medical use in Russia. In total, twenty-one domestic manufacturers, sixteen holders of registration certificates for foreign medicines, and sixteen wholesale organizations supply the medications of this category to the Russian market.\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/08c/f163574e_ea07_4ceb_81bf_800a28f7eae8.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK was shortlisted for the \"Best Law Departments Award 2019\"","date":"18.11.2019","desc":"","link":"/en/news/companynews/nanolek-was-shortlisted-for-the-best-law-departments-award-2019/","inner_date":"18.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>The Legal Department of NANOLEK was shortlisted for the \"Best Law Departments Award 2019\", which is annually organized by the Corporate Lawyer magazine.<br>\n<br>\nThe magazine's editorial board and invited experts evaluated the nominees according to 10 criteria, based on a specially developed methodology to ensure the most transparent, unbiased, systemic approach to the analysis of activities of legal departments at various companies.<br>\n<br>\nFor many decades, the legal profession has remained one of the most prestigious ones and the \"Best Law Departments Award\", as an image event, is a direct proof thereof. The contest aims to identify the leading departments showing the highest level of professionalism among Russian and international companies.<br>\n<br>\nThe festive ceremony of awarding the contest winners took place in Moscow on November 15. We thank our colleagues for the appraisal of NANOLEK's legal team! Public acceptance of success is always inspiring.<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/96d/76782759_2972631059467662_4606051133004185600_n.jpg"},{"tag":"COMPANY NEWS","title":"2nd Annual Conference \"Labeling in the pharmaceutical industry\"","date":"18.11.2019","desc":"","link":"/en/news/companynews/ii-annual-conference-labeling-in-the-pharmaceutical-industry/","inner_date":"18.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Since 2019, mandatory digital labeling of goods, including in the pharmaceutical industry, has been set in motion. According to public sources, the share of illegal drug trafficking in the Russian market is up to 10%. Launch of labeling will finally benefit all participants in the supply chain: both the state and the manufacturer, pharmacies, and consumers.<br>\n<br>\nOn November 14, Marina Zabalueva, Head of the Department for interaction with public authorities of NANOLEK, spoke at the conference “Labeling in the pharmaceutical industry” where she shared details on the current situation with introduction of labeling at our plant. To share experience with colleagues, to describe challenges, ways of overcoming them, to learn how other participants of the supply chain are doing, to find joint solutions - the meeting was organized not just for talking, but for achieving the desired outcome.<br>\n<br>\nTwo days before, on November 12, parliamentarians initiated a bill at the State Duma to provide a transitional 6-month period for the introduction of mandatory drug labeling: A monitoring of readiness for labeling showed that most pharmacies are not yet ready for a change to the new system effective from January 1, 2020. The conference participants supported this decision since millions of lives are at stake behind the technical process, therefore there is absolutely no room for mistakes.<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/3ed/DSC_9378.jpg"},{"tag":"COMPANY NEWS","title":"We congratulate the CEO of Nanolek on his birthday!","date":"15.11.2019","desc":"","link":"/en/news/companynews/happy-birthday-to-the-ceo-of-nanolek/","inner_date":"15.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>On November 15, the team of Nanolek congratulated the CEO Mikhail Nekrasov on his birthday.<br>\n<br>\nMikhail Sergeyevich can look back on a vast successful experience in the development of a large pharmaceutical business, he got in on the ground floor with NANOLEK.<br>\n<br>\nMikhail Sergeyevich received a medical education and worked a long time as a physician. Currently, he is a full member of the Russian Academy of Sciences, is the author of 3 books, 27 scientific publications and several patents in the medical industry.<br>\n<br>\nHis professional track record includes such major projects as the construction of the first Russian pharmaceutical plant certified according to EU-GMP standards, which subsequently was included in the top 5 list of pharmaceutical manufacturers in Russia; he headed a team of industrial, scientific, innovation and innovation dissemination organizations in the field of biotechnological products, including with the use of nanotechnologies.<br>\n<br>\nWise, insightful, aware, mindful, kind-hearted and passionate – we could give even a longer list of qualities inherent in Mikhail Sergeyevich. The NANOLEK team sincerely wishes health, breakthrough ideas for new discoveries, inspiration and excellent mood!<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/270/Bez-nazvaniya.png"},{"tag":"COMPANY NEWS","title":"Workshop \"Shaping the future of the pharmaceutical industry. Trends, Developments and Best practices\"","date":"14.11.2019","desc":"","link":"/en/news/companynews/workshop-shaping-the-future-of-the-pharmaceutical-industry-trends-developments-and-best-practices/","inner_date":"14.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>On November 12, 2019, a workshop on life sciences \"Shaping the future of the pharmaceutical industry. Trends, Developments and Best practices\" was held in Moscow. The workshop was organized by Exyte, a partner of NANOLEK.<br>\n<br>\nThe event brought together top chiefs of pharmaceutical and biotech companies to discuss pressing issues. We live in a rapidly changing world of technology in which the future is shaped today. It's a wastefulness for any single innovative company not to follow trends and not to respond to all new challenges that come to light.<br>\n<br>\nTo determine the future of the pharmaceutical industry, trends and special expertise, to shape a thrust of market development and growth, engineering technologies and production methods (subject to strict GMP regulations), to get to know the best practices of smart companies are global, but real goals (if we handle these issues as practitioners).<br>\n<br>\nMaxim Stetsyuk, Executive Director of NANOLEK, discussed with his peers the prospects of biotechnology development in Russia, Zakhar Golant, Chairman of the Board of the Pharmaceutical and Biotech Clusters Union, moderated. The discussion turned out to be so constructive and positive that it was extended beyond the time limits set and continued in an informal setting.<br>\n<br>\nWe would like to thank our fellow participants and organizers for a meaningful dialogue and exchange of opinions. Such meetings help maintain multilateral relationship with industry players and form an overall opinion on the state of affairs in the industry. <br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/5ba/1.jpg"},{"tag":"COMPANY NEWS","title":"Setting up production of meningococcal vaccine: new opportunities to protect russian children","date":"14.11.2019","desc":"","link":"/en/news/companynews/setting-up-production-of-meningococcal-vaccine-new-opportunities-to-protect-russian-children/","inner_date":"14.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>Sanofi and Nanolek announced a new stage in the development of a long-term partnership - the launch of a project to localize the production of a combined conjugate vaccine for the prevention of meningococcal infection. This partnership will help extend the opportunities for protecting Russian children from meningococcal infection (MI), the number of cases of which in the Russian Federation increased by 10% in 2018 as compared to 2017.<br>\n<br>\nVladimir Khristenko, President of Nanolek, comments: “We are pleased to develop a long-term partnership with Sanofi, thanks to which the most advanced vaccine production technologies can now be used in the Russian Federation. Our partner project has been over four years old; throughout this time, we have gained valuable experience and use it for the benefit of the health of Russian people. \"We greatly appreciate the opportunity to be a company partner in the Russian Federation and through our joint efforts to protect children from dangerous infections.\" <br>\n<br>\nGuillaume Oshalter, General Manager, Sanofi Pasteur Russia, and Belarus, noted: \"This year, the World Health Organization included the rejection of vaccination in the list of influential global threats to humankind. Such deliberate refusal of vaccination can lead to outbreaks of fatal and life-threatening infectious diseases. Sanofi has been contributing to the fight against vaccine-preventable infections for many years, and we are pleased to extend this successful cooperation with our reliable partner, Nanolek, to combat an extremely dangerous disease - meningitis. This is our contribution to accomplish the mission of Sanofi Pasteur, which is \"no one in the world should die nor suffer from vaccine-preventable infections.\" <br>\n<br>\nAs a preliminary stage for long-term cooperation, a Memorandum of Intent (MoI) was signed, in which the companies expressed their desire to organize local vaccine production in the Russian Federation. The result of such cooperation between the two companies will be the guaranteed and uninterrupted availability of the MI vaccine in Russia.<br>\n<br>\nAs part of the MoI, the parties agreed on the conditions necessary for the implementation of the project, including checking the compliance of the premises and equipment, as well as the packaging area of the Nanolek production site with GMP requirements and Sanofi Pasteur standards. Based on the results of the technical assessment conducted by Sanofi Pasteur, the companies will identify and evaluate investments in materials and equipment needed to organize vaccine production. The start of the production of the MI preventive vaccine at the Nanolek plant will be possible as early as 2021. <br>\n<br>\nThe companies share a common goal - to protect Russian children from vaccine-preventable infections. Sanofi Pasteur and Nanolek have already made significant steps in achieving this goal. Consequently, since 2016, the Sanofi company’s five-component combined pediatric vaccine has been localized at the Nanolek biomedical production complex. During this time, the company produced five million doses of the vaccine. Besides, since 2017, the vaccine has been successfully supplied as part of the National Calendar of Preventive Vaccinations.<br>\nToday, vaccination is the only reliable way to avoid many serious infections, as well as subsequent complications. Nowadays, vaccination is carried out for kids around the world, which saves about three million children's lives every year.<br>\n</p>\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/2e4/DSCF3940.jpg"},{"tag":"COMPANY NEWS","title":"Opening of the House of Culture in the Kirov Region Supported by NANOLEK","date":"11.11.2019","desc":"","link":"/en/news/companynews/opening-of-the-house-of-culture-in-the-kirov-region-supported-by-nanolek/","inner_date":"11.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tThe project is aimed at solving socially significant problems. Its uniqueness lies in the fact that improving the quality of life of the municipality depends, first of all, on the activity of the population. Residents themselves decide which project should be implemented, and a guarantee must be found for such an initiative, which, in the event of victory in the competition, will allocate charitable funds.\n\nIn 2019, the Ugorsky Rural Settlement (the administrative center is the village of Ugor of the Verkhoshizhemsky District) took part in the PSLI with the project called “The Spirit of the Homeland is Strong”. NANOLEK supported the initiatives of the villagers and became the guarantor of the project.\n\nWhat is its essence? The fact is that in the Ugorsky rural settlement, there is an old building of the local house of culture which fell into such disrepair that the locals even thought to demolish the dilapidated structure, which at first glance could not be restored... But tearing down does not mean to build, and why destroy if you can save it?\n\nThanks to a group of residents and the help of the Administration, a new roof was installed in early June. Then repair work began inside the building itself.\n\nThe House of Culture for the village is a center of leisure, spiritual development, and education because it is here that exhibitions, film screenings, children's art groups, and dances for young people are organized! As many as 526 residents of the village of Ugor will soon spend their free time in the renovated, restored building of the recreation center because the first confident steps to this have already been taken.\n\nOn November 8, the inauguration of the House of Culture took place after the restoration process, to which Mikhail Nekrasov, the General Director of NANOLEK, and the leaders of the Verkhoshizhemsky District were invited. Congratulations to the Ugrians, and we wish you success!\n\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f7d/1.JPG"},{"tag":"COMPANY NEWS","title":"NANOLEK visits CPhI Worldwide 2019","date":"08.11.2019","desc":"","link":"/en/news/companynews/nanolek-visits-cphi-worldwide-2019/","inner_date":"08.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tFrom 5 to 7 November, Frankfurt am Main hosted the world's largest pharmaceutical industry trade show CPhI Worldwide, which was attended by employees of NANOLEK: Svetlana Efimova (Deputy CEO for Operations and Partnership Development), Artem An (Head of Strategic Development Department), Yuri Bobrov (Head of Procurement and Logistics Division) and Natalia Zaets (Business Analyst).<br>\n <br>\n The fair brought together more than 45 thousand guests from 143 countries and 2,500 exhibitors. Visiting CPhI Worldwide is an effective way to make new business contacts, track the latest global trends in the industry, discuss advanced solutions in the pharmaceutical sector.<br>\n <br>\n CPhI exposition schedule is prudently divided into 6 thematic tracks, which were represented by leading companies specializing in the production of latest-generation drugs, laboratory and clinical research, pharmaceutical developments, equipment suppliers, services rendered by contract manufacturers, distributors, licensing specialists as well as companies that produce customized packaging for pharmaceutical drugs. Biological drugs and ingredients were showcased at the BioProduction exhibition area organized for the first time this year.<br>\n <br>\n Representatives of NANOLEK held more than 100 meetings with leading industry experts, discussed current development tendencies of the pharmaceutical market and possible forms of international cooperation.<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d3c/Bez-nazvaniya-_1_.png"},{"tag":"COMPANY NEWS","title":"NANOLEK at the IX International partnering forum \"Life Sciences Invest. Partnering Russia\"","date":"07.11.2019","desc":"","link":"/en/news/companynews/nanolek-at-the-ix-international-partnering-forum-life-sciences-invest-partnering-russia/","inner_date":"07.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tOn November 7-8, 2019, Saint Petersburg hosts the IX International partnering forum \"Life Sciences Invest. Partnering Russia\" that is primarily focussed on supporting relevant federal initiatives in the development of the industry market.<br>\n <br>\n Economic prosperity of a specific country is based on comfortable life of its citizens, social security, promotion of peoples' health. Ambitious goals require a comprehensive approach to their achievement, that is why this year the main subject of discussions were the ways to improve the investment attractiveness of the Russian Life Sciences market; achieving the national health goals for the period up to 2024; drug safety and affordability; transfer of technology and innovations; improvement of state support measures for the pharmaceutical sector; establishment of national drug policy; development of partnership relations with global clusters.<br>\n <br>\n Maxim Stetsyuk, Executive Director of NANOLEK, took part in the thematic session \"Implementation of medicine provision principles\" moderated by Zakhar Golant and Herman Inozemtsev.<br>\n <br>\n Participants of the panel discussion - Lyudmila Sychevskaya (Health committee of St. Petersburg), Vadim Tarasov (Sechenov First Moscow State Medical University, Arkady Stoplner (Berezin Medical Institute) - discussed the development of the medicine provision system for various patient groups, including high cost and orphan drugs as well as the prospects for launching the mechanisms of interaction models on risk-sharing and cost-sharing basis.<br>\n <br>\n Maxim Stetsyuk outlined the peculiarities of vaccine production considering the need to sign long-term government contracts as well as the prospects for the affordability of breakthrough biological drugs for Russians through a step-by-step expansion of local manufacturing with due regard to technological environment.<br>\n <br>\n \"If it comes to the development of an overall strategy as part of the health system, we should keep in mind that profitable investments are a contribution towards prevention of diseases. It all starts with proper nutrition, development of sports culture in the country, immunoprophylaxis, development of disease diagnosis and treatment programs and only once we have reached this stage we can talk about drug provision.<br>\n <br>\n As a representative of a vaccine manufacturer, I would like to stress that we still have to tackle various challenges despite existing statutory provisions. I will give an example: currently, we produce polio vaccines in 5-dose vials and would like to switch to disposable syringes with monodoses (to ensure ease of use and reduce financial losses since an opened vaccine is no more storable), however we confront ourselves with price control issues: switching to disposable syringes does not play into the prices proposed by the government.<br>\n <br>\n Besides, the country needs to expand analytical bases by making high-quality, regular health checkups (periodic health assessments should be cultivated among people). Laboratories should gather new experience in conducting complex tests to deliver analytics for pharmaceutical companies as a basis to create immunobiological drugs. In this respect, we closely collaborate with universities and educational institutions to meet the need for skilled employees.<br>\n <br>\n All these challenges are solvable as part of the strategy that can be developed through a close interaction between the state and the commercial sector only,\" said the Executive Director of NANOLEK.<br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/9ec/1.jpg"},{"tag":"COMPANY NEWS","title":"The delegation of NANOLEK participates in the annual meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN)","date":"06.11.2019","desc":"","link":"/en/news/companynews/delegatsiya-nanolek-prinyala-uchastie-v-ezhegodnom-soveshchanii-proizvoditeley-vaktsin-dcvmn/","inner_date":"06.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tPresident of NANOLEK Vladimir Khristenko and Deputy CEO for Research and Development Timofey Nemankin took part in the XX annual conference of the Developing Countries Vaccine Manufacturers Network (DCVMN) that was held in late October in Rio de Janeiro.<br>\n <br>\n Currently, the Alliance includes 50 companies in 17 countries that produce more than 40 types of vaccines (considering the use of different technologies, DCVMN members produce about 200 products), 40 of them have been pre-qualified by WHO. NANOLEK became a member of DCVMN in April 2019.<br>\n <br>\n Vladimir Khristenko and Timofey Nemankin exchanged experience with foreign colleagues - industry experts, discussed export prospects with international pharmaceutical corporations.<br>\n <br>\n DCVMN (Developing Countries Vaccine Manufactures Network) is an Association whose vision and mission is to improve the quality of vaccines produced and ensure their affordability to protect people against infectious diseases. The largest producers have been united to form a single global association that accumulates general efforts aimed at fight against serious diseases amenable to vaccination.<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/dbb/22out_dcvmn2019_25.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is a partner of KIROV URBAN FORUM-2019","date":"05.11.2019","desc":"","link":"/en/news/companynews/nanolek-partner-kirov-urban-forum-2019/","inner_date":"05.11.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tOn October 31 and November 1 this year, Kirov hosted the second urban forum, which was partnered by NANOLEK.<br>\n <br>\n KIROV URBAN FORUM is a single discussion platform that focuses on development of public areas and brings together representatives of authorities, developers, businessmen and ordinary citizens. Shaping ideas for the development of the urban environment, implementation of projects are impossible without a constructive dialogue of stakeholders. Therefore, for the second time in a row the forum brings together more than 20 influential experts in urbanism and offers topical issues for discussion.<br>\n <br>\n The key topic in 2019 was urban health. The experts also discussed the issues regarding balanced development of cities, psychology of architecture perception, regional practice of urbanism, adoption of digital technologies, preservation of historical legacy and many others.<br>\n <br>\n Comfortable and cleverly designed urban environment is a key to quality life and effective placemaking. NANOLEK is actively engaged in the development of the region's infrastructure both economically and by developing the educational track in cooperation with leading educational institutions.<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/9ff/Bez-nazvaniya.png"},{"tag":"COMPANY NEWS","title":"NANOLEK confirmed that it meets a high quality standard","date":"30.10.2019","desc":"","link":"/en/news/companynews/nanolek-podtverdil-sootvetstvie-vysokomu-standartu-kachestva/","inner_date":"30.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tModern hi-tech company’s activities are impossible without constant maintenance of a functioning quality management system, particularly, in the area of pharmaceutical production. Therefore, each year NANOLEK undergoes a comprehensive inspection that results in issuance of a Quality Management System Certificate of Conformity ISO 9001.<br>\n <br>\n A company that obtains the certificate thus confirms that it meets international standards, guarantees compliance with the established standards relating to the organisation of technological and business processes, which in turn, ensures high quality of produced goods.<br>\n <br>\n NANOLEK complies with the principles of openness in cooperation with Russian and international partners, and the Quality Management System Certificate of Conformity shows that we are reliable!<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/d13/sert_1_.jpg"},{"tag":"COMPANY NEWS","title":"'Pharmaceutical Market Promotion of the Eurasian Economic Union' Conference funded by NANOLEK","date":"29.10.2019","desc":"","link":"/en/news/companynews/konferentsiya-razvitie-farmatsevticheskogo-rynka-evraziyskogo-ekonomicheskogo-soyuza-pri-podderzhke-/","inner_date":"29.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The conference welcomed the representatives of the ECE line departments, heads of executive authorities of the EEU states, medical communities and manufacturers to share and develop proposals on the enhancement of the industry promotion in the ECE.\n</p>\n<p>\n\t Maksim Stetsyuk, Executive Director for NANOLEK, spoke at the conference on the role of bio-safety in pharmaceutical production. He noted that the issue of biosafety is not limited, therefore it is especially worthwhile creating updated approaches to preventive vaccination and ensure the availability of high-quality, including multicomponent, and well tolerated vaccines.\n</p>\n<p>\n\t “There is a successful case in our brand portfolio where we could arrange, as soon as possible, the availability of inactivated polio vaccine in accordance with the needs of the state customer. This was managed thanks to the inclusion of the drug in the list of strategically valuable medicines 2010. For us, the factor to define the further project development is definitely aguarantee of long-term demand for the new products from the state authorities. By introducing the uniform rules for pharmaceuticals registration, we hope that Russia-manufactured vaccines will be demanded by customers from other EEU states as part of national immunization schemes. Welcome. We are open for collaboration,\" Maksim added.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/027/1-_1_.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK presented the Inactivated Poliovirus Vaccine Project on the Russia-Africa Summit","date":"28.10.2019","desc":"","link":"/en/news/companynews/nanolek-predstavil-proekt-po-ipv-na-sammite-rossiya-afrika/","inner_date":"28.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tOn October 23-24, the first Russia-Africa Summit was held in Sochi. The heads of all the African Continent states, as well as the heads of the largest regional unions and organizations were invited to attend the event.<br>\n <br>\n The special focus was on the status and prospects of relations between Russia and the African continent states, promotion of relations in the political, economic, humanitarian, cultural and other spheres. The experts exchanged opinions on the development of counter terrorism and cross-border crime activities, along with other challenges and threats to regional and global security.<br>\n <br>\n Marina Mazurevskaya, Deputy Director General for Legal Affairs and Government authorities relations for NANOLEK, took part in the “Biosafety: Current Projects and Integrity Prospects\" Session dedicated to the collaboration between the countries relating to the mutual investigation of infectious diseases and disease management.<br>\n<br>\n The representatives of the national authorities of RF, line ministers of the Uganda Republic, Kongo Republic and Guinea Republic spoke at the session.<br>\n <br>\n Marina spoke of the NANOLEK project status on the development and production of the first national inactivated poliovirus vaccine (IPV) jointly with Chumakov Institute, RAN, that began in July 2019, as well as on the potential opportunity to collaborate with the African countries on vaccine export and know-how transfer.<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/1b4/1.jpg"},{"tag":"COMPANY NEWS","title":"The Corporate Purchases 2019 Summit with participation of NANOLEK","date":"28.10.2019","desc":"","link":"/en/news/companynews/sammit-korporativnye-zakupki-2019-pri-uchastii-nanolek/","inner_date":"28.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n</p>\n<p>\n\t The summit was held on October 24 and 25 in Moscow under the motto: “A Shoot Forward: Purchasing 4.0. Cooperation for Success.”\n</p>\n<p>\n\t The program presented the best cases and solutions of the procurement industry. The experts discussed some successfully implemented examples in the procurement management; building an ecosystem of procurement within the company, the issues of adapting to innovations in legislation, the features of building a capable team, digital transformation, category strategies, and other topics.\n</p>\n<p>\n\t Svetlana Efimova spoke about the peculiarities of the procurement management in the pharmaceutical industry in the context of import substitution, about solutions in the implementation of procurement processes taking into account the raw material component, the role of high technologies in the process of import substitution, as well as the use of new platforms and stages of the supply chain development.\n</p>\n<p>\n\t NANOLEK actively takes part in business events that help to exchange experience with market experts and discuss current industry issues.\n</p>\n <br>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f9d/1.jpg"},{"tag":"COMPANY NEWS","title":"Conference: Actual problems of Epidemiology of infectious and non-infectious Diseases","date":"25.10.2019","desc":"","link":"/en/news/companynews/konferentsiya-aktualnye-problemy-epidemiologii-infektsionnykh-i-neinfektsionnykh-bolezney/","inner_date":"25.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n</p>\n<p>\n\t On October 24 and 25, NANOLEK took part in the conference called Actual Problems of the Epidemiology of Infectious and Non-infectious Diseases, organized by the National Association of Specialists in Infection Control.\n</p>\n<p>\n\t The conference participants - the experts from Roszdravnadzor, Rospotrebnadzor, epidemiologists, medical doctors, bacteriologists, and other specialists - discussed health issues, the modern concept of vaccine development in Russia, the development of a national calendar of vaccinations, molecular methods for ensuring epidemiological safety, and many others. \n</p>\n<p>\n\t Vaccination is one of the focal points for NANOLEK. The company supports the medical community, believing that vaccination is an effective method of protection against many dangerous diseases caused by viruses and infections, and vaccine-preventable diseases can only be stopped by joining forces.\n</p>\n <br>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/410/74188832_2483003678651034_6897287061523398656_o.jpg"},{"tag":"COMPANY NEWS","title":"JANSSEN AND NANOLEK LAUNCH A PROJECT TO LOCALIZE DARZALEX® FOR THE TREATMENT OF MULTIPLE MYELOMA","date":"24.10.2019","desc":"","link":"/en/news/companynews/janssen-and-nanolek-launch-a-project-to-localize-darzalex-for-the-treatment-of-multiple-myeloma/","inner_date":"24.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Janssen, the pharmaceuticals division of Johnson & Johnson LLC, and the Russian biopharmaceutical company NANOLEK announce localization of Darzalex® (daratumumab), a medication used for the treatment of multiple myeloma, in the Russian Federation. <br>\n <br>\n\t “The fight against hematological malignancies has been one of Janssen's strategic focus areas for many years. Our team is working hard to find new molecules, launch these on the market and expand access to the treatment for such serious and difficult to treat diseases as multiple myeloma. This year, our innovative drug daratumumab was included in the high-cost nosologies program, which gives hope to many patients across the country. In order to support this valuable achievement, we also want to reaffirm our commitment to the local strategy in Russia, and are pleased to announce cooperation with one of the leading Russian manufacturers, the biopharmaceutical company NANOLEK, to localize Darzalex®. We believe that this kind of joint work helps to increase access of the Russian patients to innovative therapy,” says Katerina Pogodina, Managing Director for Russia and the CIS at the Janssen Pharmaceutical Companies, General Director of Johnson & Johnson LLC.\n</p>\n<p>\n\t Localization of Darzalex® will be conducted at the facilities of the NANOLEK Biomedical Complex located in the Kirov region, in accordance with the GMP and ISO standards.\n</p>\n<p>\n\t Vladimir Khristenko, President of NANOLEK, said:\n</p>\n<p>\n</p>\n<blockquote>\n\t Today we can talk about global innovations and enormous reserves to increase the life expectancy of the population, particularly in the area of cancer therapy. Our partnership with Janssen is of great social importance – by pooling together our efforts, we will be able to make a significant positive contribution to the life of Russian patients with hematological malignancies. Our joint localization project will increase patient access to modern and effective therapy for patients with a hard to treat form of cancer – multiple myeloma. I am pleased that this cooperation will help to solve one of the most difficult medical problems and significantly improve the duration and quality of life of the Russian patients. <br>\n</blockquote>\n \n<p>\n\t Oncology, along with vaccines, today is one of the focal areas for NANOLEK. The company is actively developing its portfolio of drugs for the treatment of cancer, both in cooperation with major international companies and through its own efforts.<br>\n\t In 2017, Darzalex® was approved in Russia and launched on the market for use as monotherapy in patients with recurrent or refractory multiple myeloma who were previously treated with protease inhibitors and immunomodulating drugs. In 2019, the instructions for use were amended due to a broadening of the indications for the product. Darzalex® is now also recommended for use in combination therapy for adult patients with multiple myeloma. Daratumumab is the first human anti-CD38 monoclonal antibody approved for the treatment of this disease.<br>\n <br>\n\t Janssen has been contributing to the fight against hematological malignancies in Russia for over 10 years, studying molecular and cellular mechanisms of disease development and launching innovative drugs on the market. Thanks to Janssen, a breakthrough was achieved in the treatment of multiple myeloma in 2007, and the drug Darzalex® which appeared on the Russian market in 2017, was repeatedly recognized as a breakthrough therapy by global regulatory agencies. In September 2019, as part of the Make Blood Cancer Visible information campaign, a special project to raise awareness of malignant blood disorders was launched together with Glamour magazine.<br>\n\t <br>\n\t Darzalex® is the first fully human monoclonal antibody to act on the CD38 surface protein, which is highly expressed on all myeloma cells regardless of the stage of the disease. The innovative mechanism of action of Darzalex® causes rapid death of tumor cells by several mechanisms. Darzalex® induces myeloma cell destruction due to CD38-mediated immune mechanisms (complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity and antibody-dependent phagocytosis), apoptosis and CD385 enzymatic activity modulation.\n</p>\n<p>\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/fb3/5.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK - a participant of the Summit of Chief Financial Officers of Russia","date":"23.10.2019","desc":"","link":"/en/news/companynews/nanolek-a-participant-of-the-summit-of-chief-financial-officers-of-russia/","inner_date":"23.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 23, Evgeny Barinov, Deputy General Director for Finance and Digital Technologies of NANOLEK, took part in the annual Summit of CFOs of Russia.\n</p>\n<p>\n\t The Summit is the central meeting place of the CFO community from all over Russia and abroad. Representatives of almost all sectors of the economy have the opportunity in a dialogue format to exchange experiences and discuss the latest industry events.\n</p>\n<p>\n\t In the panel discussion - CFO in Rapid Development of Information Technology - the experts discussed all the trends and practices in managing the financial function in the context of the rapid development of digitalization. How will the processes change after the introduction of new technologies? What needs to be taken into account when introducing Big Data in a company? How to protect yourself from cyber threats as much as possible? And many others. \n</p>\n<p>\n\t Evgeny Barinov: \"The NANOLEK team built the biopharmaceutical plant from scratch. We were engaged in the implementation of a large number of different systems and the automation of financial functions. When building a strategy for the next five years, we are guided by the thesis - \"automation is not digitalization\". Automation of processes is a trend of the industrial 20th century. The role of CFOs will definitely shift towards digitalization because these are new business models and digital service platforms. A CFO, in this case, acts as a business partner and ideologist. We support this trend. \n</p>\n<p>\n\t If we talk about digital transformation in general, then, for example, we, as a manufacturer, have the idea of creating a new service, with which you can build your vaccination calendar. It will be a single digital platform that will unite all vaccine manufacturers, clinics, offer a convenient interface for recording, receiving feedback, and other functions. This is an example of how a traditional manufacturer can find its niche in the digital transformation of the industry.”\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/b6e/BAB5646.jpeg"},{"tag":"COMPANY NEWS","title":"NANOLEK is a Participant of the 8th Open Innovations Moscow International Forum","date":"21.10.2019","desc":"","link":"/en/news/companynews/nanolek-is-a-participant-of-the-8th-open-innovations-moscow-international-forum/","inner_date":"21.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 21, Aleksey Ryzhyi, Director of the Department of Information Technology at NANOLEK, took part in the Digital Champions. Digitalization as a Source of Rapid Growth for High-Tech Companies round table as part of the 8th Open Innovations Moscow International Forum.\n</p>\n<p>\n\t Digital technologies have burst onto the Russian business scene, but at the same time, not all companies are hurrying to join the digital race. During the round table, the experts discussed the Russian companies' need for digital transformation, the justification for expending resources to introduce modern technologies into business processes, and the relevance of process digitalization in various sectors of the economy.\n</p>\n<p>\n\t Representatives of fast-growing technology companies shared their implementation experience, talked about what digital technologies they use in their work, described the pros and cons of purchasing ready-made solutions vs. developing their own, and presented cases that evaluated the effectiveness of digital technologies in promoting business economic growth.\n</p>\n<p>\n\t Aleksey Ryzhyi: “Recently, NANOLEK has approved an ambitious five-year company development strategy. Within it, IT department specialists developed a strategy for a transition from digital optimization (improving the performance of current processes, improving user experience) to digital transformation (new products and value streams, new business models). We combined plans for both traditional IT activities (target SLA, updating infrastructure, finalizing software), and in terms of project management methods and tools, preparing business partners in our areas, developing a data-driven culture and plans for work with startups.\n</p>\n<p>\n\t When entering the project, we always prepare a justification for its necessity and a list of goals whose achievement should lead to specific effects. We are confident that such an approach to the implementation of classic IT projects while developing a new culture of dealing with information by each employee will help maintain the company's dynamic development and create a flexible pharmaceutical company capable of rapid changes.”\n</p>\n <br>\n <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/bfb/9.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK REPRESENTATIVES TOOK PART IN A BUSINESS VISIT TO TURKEY AS PART OF THE GOVERNMENT DELEGATION OF THE KIROV REGION","date":"17.10.2019","desc":"","link":"/en/news/companynews/nanolek-representatives-took-part-in-a-business-visit-to-turkey-as-part-of-the-government-delegation/","inner_date":"17.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The meeting with the Turkish business community was dedicated to the investment potential of the Kirov region, as well as expansion of the economic ties between the Republic and the region.<br>\n <br>\n\t Attracting the attention of foreign investors to the development of the Kirov regional economy opens up prospects for the development of many industries, including pharmaceuticals. The Russian delegation headed by Alexander Churin, the Chairman of the Kirov Regional Government, visited industrial enterprises in Istanbul, including pharmaceutical ones: Onko & Koçsel İlaçlar (manufacturer of anti-cancer and hematological drugs) and Nobel Ilac Nobe (the oldest pharmaceutical company in Europe).<br>\n <br>\n\t Mikhail Nekrasov, as an industry representative, discussed the areas of possible future cooperation: export of domestic drugs to the Turkish market, joint projects in the field of manufacturing, and technology transfer.<br>\n <br>\n\t Questions have been asked, and a start has been made – the business mission will be continued during a return visit of the Turkish partners to the Kirov region.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/4ae/6.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK IS A PARTICIPANT OF THE ALL-RUSSIAN FORUM ON PUBLIC HEALTH","date":"14.10.2019","desc":"","link":"/en/news/companynews/nanolek-is-a-participant-of-the-all-russian-forum-on-public-health/","inner_date":"14.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t The main topic for discussion was immunization, which is recognized worldwide as the only effective way to protect the population and save millions of lives. Let us turn to the convincing statistical facts: In 2017, vaccination helped to reduce the number of deaths in children (aged under 5 years) worldwide by 30%.\n</p>\n<p>\n\t However, fears and myths that surround life-saving vaccination impede the full expansion of this process. Do you know, for instance, that the flu vaccine is produced anew every year, based on the data collected from 150 research centers around the world? They monitor, analyze the situation and suggest only the currently circulating strains. The centers give recommendations to manufacturers as to what antigenic characteristics should be included in the vaccine. As a result, the vaccinated person either does not get sick at all during the outbreaks, or has a relatively mild form of disease without serious complications that sometimes lead to irreparable consequences...\n</p>\n<p>\n\t The World Health Organization actively supports the message that it is the refusal to vaccinate that is becoming a global threat to humanity. For example, in France vaccination is recognized as mandatory at the state level, and refusing it can entail a fine of 3,750 euros or a 6-month imprisonment...\n</p>\n<p>\n\t What is the situation in domestic healthcare? What problems arise in the battle against major socially significant diseases? What vaccines need to be introduced in the national vaccination schedule to protect against socially significant infections? How to increase public awareness of vaccines and build a sustainable compliance? These are some of the issues discussed today by representatives of government agencies, medical institutions, mass media and business.\n</p>\n<p>\n\t Vladimir Khristenko: “The main trend today is the transition from a single vaccine to combined products. Already now you may need only 2 vaccines to achieve protection against 10 infections: one against diphtheria, pertussis, tetanus, Haemophilus influenzae infection, polio, hepatitis; and the second against measles, rubella, chickenpox and mumps. And this is a real breakthrough. Monovaccines are quite relevant to the issue of building compliance: not every parental heart will withstand 10 visits to get 10 shots for their child.\n</p>\n<p>\n\t I would like to note another trend – I hope that a number of diseases that are infectious but traditionally not vaccine-controlled may obtain this status in the nearest future. This primarily refers to HIV, hepatitis C, respiratory syncytial virus etc. This area is under active development.\"\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/c0e/4.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK TOOK PART IN A WHO SESSION ON IMMUNIZATION","date":"11.10.2019","desc":"","link":"/en/news/companynews/nanolek-took-part-in-a-who-session-on-immunization/","inner_date":"11.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t Evgeny Barinov, Deputy CEO of Finance and Digital Technology, and Artem An, Director of Strategic Business Development, took part in the three-day WHO SAGE (Strategic Advisory Group of Experts) session on immunization in Geneva.\n</p>\n<p>\n\t This annual session brings together representatives of the WHO, UNICEF, GAVI, regional regulatory authorities, vaccine research community and vaccine manufacturers with the aim of summing up the year's results on the immunization status in 180+ countries, discussing the effectiveness of certain vaccines, and presenting an action plan for the future years.\n</p>\n<p>\n\t At the current session, special attention was paid to vaccination to prevent such infections as measles, rubella, human papillomavirus (HPV), Ebola and polio. It is for these diseases that concern of the global community has remained very high in recent years, and the WHO is making a serious effort to overcome all the difficulties over the next decade.\n</p>\n<p>\n\t The SAGE session meeting agenda was quite packed. Artem and Evgeny introduced NANOLEK as a key player in the Russian domestic vaccine market, and discussed joint UNICEF collaboration plans with respect to inactivated polio vaccine (IPV) and HPV vaccine.\n</p>\n<p>\n\t Evgeny Barinov: “NANOLEK took part in the SAGE session for the first time, and this underscores the importance of the current stage in the company development. In the future, while developing and manufacturing its own vaccines, NANOLEK would like to partner with UNICEF for their supply. The course of the meetings has shown that the WHO representatives are ready to seriously consider us as a potential approved supplier. There is still a huge amount of work ahead, but a successful start has been made.”\n</p>\n<p>\n\t Artem An: “The battle against serious infections and viruses threatening human life and well-being cannot be merely a local goal. This is a global topic, and we want to be the obvious answer to the needs and requirements of the international community for effective immunization.”\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/f24/3.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is participant of the Forum “Regulation in Healthcare-2019”","date":"09.10.2019","desc":"","link":"/en/news/companynews/nanolek-is-participant-of-the-forum-regulation-in-healthcare-2019/","inner_date":"09.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t At the beginning of October, Kazan hosted the Forum “Regulation in Healthcare-2019”, in which Marina Mazurevskaya, Deputy Director General for Legal Affairs and Work with Government Agencies, took part.\n</p>\n<p>\n\tThe forum was organized by the Federal Antimonopoly Service and the Ministry of Health of the Republic of Tatarstan. Experts raised questions of state support for vaccine manufacturers, pricing, long-term contracts, and many others.\n</p>\n<p>\n\t Marina Mazurevskaya, “We hope that within the framework of SPIC 2.0 tools, federal offset contracts, it will be possible to come up with a wide range of non-price measures to support domestic manufacturers of immunobiological drugs and ensure the availability of our own vaccine production for the current and promising national calendar of vaccinations.”\n</p>\n<p>\n\tNANOLEK is an active participant in such forums, because the dialogue between the authorities and the industry contributes to the development of effective solutions and the definition of a common plan of action.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/4c4/10.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is participant of the XI International Conference \"What is happening on the pharmaceutical market?\"","date":"07.10.2019","desc":"","link":"/en/news/companynews/nanolek-is-participant-of-the-xi-international-conference-what-is-happening-on-the-pharmaceutical-ma/","inner_date":"07.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 3 Maxim Stetsyuk, Executive Director of NANOLEK, became a participant in the XI International Conference “What is happening on the pharmaceutical market?”.\n</p>\n<p>\n\t The conference is the main meeting place for the main players of the pharmaceutical community: heads of representative offices, general directors and top managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulators, professional and business media.\n</p>\n<p>\n\tMaxim Stetsyuk took part in the session “A labeling of medicines again. And questions again. ” Experts from <a href=\"http://www.roszdravnadzor.ru/en/\">FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE</a>, as well as top managers of pharmaceutical companies, distributors and pharmacy chains talked about practical experience in introducing labeling, the readiness of the entire supply chain for implementation, the main problems of drug manufacturers and equipment manufacturers, the possible introduction of fines for the sale of drugs without labeling, etc. \n</p>\n<p>\n\t “The company NANOLEK has installed the necessary equipment and now we are at the stage of active testing of the test period. On October 2019, we will begin to mark the first orphan drug. \n</p>\n<p>\n\t In order for the whole system to work properly, the process of forming interaction with other participants in the system is necessary (manufacturer - distributor - pharmacy - manufacturer of healthcare facilities), with the scaling of all processes, these problems can turn into serious failures. This must be taken into account and an adequate response system developed, including at the legislative level with the assignment of statuses and certain decisions in a given situation.\n</p>\n<p>\n\t In anticipation of labeling, two main things need to be done: the regulator to interview all the major market participants about their readiness and, based on the results of the survey, issue the relevant instructions,” commented by Maxim Stetsyuk.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/6c9/8.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK took part in the Golden Feather festival in Verkhoshizhemsky district","date":"04.10.2019","desc":"","link":"/en/news/companynews/nanolek-took-part-in-the-golden-feather-festival-in-verkhoshizhemsky-district/","inner_date":"04.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 5 in Russia will celebrate Teacher's Day.\n</p>\n<p>\n\t Do you remember your first teacher? And which of the many teachers was the most beloved? Do you meet classmates years later?\n</p>\n<p>\n\t Teacher's Day is an excellent occasion to recall school years, pranks, first love and first lessons of life ... Recall the inveterate losers and diligent honors pupils, the square of the hypotenuse, litmus papers and exploits of Barclay de Tolly ... But the main ones in the memories will be forever our beloved Teachers.. How many songs have been sung, how many verses are dedicated to dear Mentors, whom we will gently keep in our memory all our lives?\n</p>\n<p>\n\t The profession of a teacher is a magical job. And not only because it is associated with the transfer of knowledge to a new generation. And also, because if the teacher chose this path, he is unlikely to turn away from it ... It is very important not to forget about it and pay tribute to the work of the teacher.\n</p>\n<p>\n\t In the Verkhoshizhemsky district (Kirov region) in early October, the Golden Pen festival was held, dedicated to Teacher’s Day and the 90th anniversary of the district. By the way, 150 teachers are working in the district now! NANOLEK has supported the Department of Education for many years and we could not stay away this time: veterans of pedagogical activity and the best teachers of the region were awarded with diplomas, letters of thanks and valuable gifts. \n</p>\nWords of sincere gratitude inspire you not to stop and\nto do even more good every day. Even a little attention will be an expensive\ngift: find an hour of free time, go to your favorite teacher with a bunch of\nflowers ... it's so simple, but so valuable!\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/c51/7.jpg"},{"tag":"COMPANY NEWS","title":"Geneticists discussed modern approaches to the treatment of orphan disease at the scientific and practical seminar “Type II mucopolysaccharidosis. Modern approaches to therapy - a specialist’s view”","date":"03.10.2019","desc":"","link":"/en/news/companynews/geneticists-discussed-modern-approaches-to-the-treatment-of-orphan-disease-at-the-scientific-and-pra/","inner_date":"03.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t On October 1 in Tver a scientific and practical seminar “Type II mucopolysaccharidosis Modern approaches to therapy - a specialist’s view” held. The event was held under the patronage of the chief freelance geneticist of the Ministry of Health of the Tver region Elena Mikhailovna Kochegurova. The speaker was also a professor, chief researcher at the Veltischev Research and Clinical Institute for Pediatrics of the Pirogov Russian National Research Medical University Alla Semyachkina. \n</p>\n<p>\n\t Experts highlighted the issues of differential diagnosis of orphan disease of type II mucopolysaccharidosis, drug provision of patients, as well as modern approaches to therapy. \n</p>\n<p>\n\t Elena Kochegurova drew attention to the experience of using idursulfase beta as an enzyme replacement therapy in the world, and also emphasized the issues of individualizing the patient’s therapeutic tactics and choosing the right therapy. The chief specialist concluded that, thanks to a timely diagnosis and early initiation of therapy, the prognosis of the disease can be significantly improved.\n</p>\n<p>\n\t Recently, the medical community has been paying close attention to rare diseases, which as a result allows us to develop an integrated approach to solving the problems of this issue.\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/538/5.jpg"},{"tag":"COMPANY NEWS","title":"NANOLEK is a partner of the All-Russian competition of the Dynamo society in sambo and combat sambo","date":"02.10.2019","desc":"","link":"/en/news/companynews/nanolek-is-a-partner-of-the-all-russian-competition-of-the-dynamo-society-in-sambo-and-combat-sambo/","inner_date":"02.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<p>\n\t In Kirov, the Dynamo All-Russian Sambo and Combat Sambo competitions among men and women are taking place, in which the country's strongest athletes, world and European champions, international-class masters of sports take part.\n</p>\n<p>\n\t Alexander Churin the Chairman of the Government of the Kirov Region arrived to support 300 fighters from 20 regions of Russia. The best athletes will be selected for the championship of Russia, which will be held in 2020 in Chelyabinsk.\n</p>\n<p>\n\t NANOLEK welcomes a healthy lifestyle and a passion for sports, which is why the company actively supports the Kirov competitions. Staying power, endurance, will, temper are the main qualities that educate sambo classes.\n</p>\n<p>\n\t Mikhail Nekrasov, General Director of NANOLEK, presented the medals to the first winners. Congratulations to the winners and wish you success!\n</p>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/710/2.jpg"},{"tag":"COMPANY NEWS","title":"Top managers of NANOLEK entered the annual rating of Russian business leaders","date":"01.10.2019","desc":"","link":"/en/news/companynews/top-managers-of-nanolek-entered-the-annual-rating-of-russian-business-leaders/","inner_date":"01.10.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tThe Association of Managers, with consulting support from the Kommersant Publishing House, has published a list of Top 1000 business leaders, which includes the best managers in Russia.<br>\n <br>\n The NANOLEK company is represented in the rating list by three top managers at once:<br>\n<ul>\n\t<li>Top 250 Top managers: Vladimir Khristenko President</li>\n\t<li>Top 100 commercial directors: Maxim Stetsyuk Executive Director</li>\n\t<li>Top 100 HR directors: Yana Ageeva Deputy General Director for Human Resources.</li>\n</ul>\n We congratulate our colleagues on their well-deserved success and wish them new wins!<br>\n The “Top 1000 Russian Managers” is a prestigious award, which has been implemented annually since 2001, sums up the work for the year and identifies the most professional managers in Russia. <br>\n <br>\n Link: <a href=\"https://vk.com/away.php?to=https%3A%2F%2Fwww.kommersant.ru%2Fdoc%2F4109977&post=-108569570_298&cc_key=\" target=\"_blank\">https://www.kommersant.ru/doc/4109977</a> <br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/e26/Snimok_ekrana_2019_10_01_v_11.49.00.png"},{"tag":"COMPANY NEWS","title":"NANOLEK - participant of the IV GMP conference","date":"30.09.2019","desc":"","link":"/en/news/companynews/nanolek-participant-of-the-iv-gmp-conference/","inner_date":"30.09.2019","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tCompany representatives visited one of the most significant events for the pharmaceutical industry in Russia. The organizers of event The Ministry of Industry and Trade of the Russian Federation and the State Institute of Medicines, gathered more than 1,200 experts and guests, not only from Russia but from around the world.<br>\n <br>\n This year, the GMP conference was held under the slogan “Good Practices: Uniting the Industry and the World”, because the current year is held under the auspices of export for domestic pharmaceuticals. CIS and EAEU countries are the main supply markets for Russian products (120 countries).<br>\n <br>\n Issues for discussion that formed the basis of a rich business program: investment in scientific activity, special conditions for the registration of breakthrough drugs, labeling, development of trade relations, harmonization of legislation and transition to a single market, building relationships with regulators of other countries, evaluation of export markets, biotechnological engineering productions and many other themes.<br>\n <br>\n For NANOLEK, participation in the conference is practical - colleagues managed to discuss the technical aspects of interaction with international partners, licensing issues, GMP-inspection of production sites, external training for employees and many other pressing topics.<br>\t\t\t\t\t\n\t\t\t","source":"","image":"/upload/iblock/8a9/4.jpg"},{"tag":"НОВОСТИ КОМПАНИИ","image":"","title":"Vladimir Khristenko appointed as President of Nanolek","date":"19.06.2015","link":"/en/news/companynews/vazhnoe-kadrovoe-naznachenie-v-kompanii-nanolek/","inner_date":"19.06.2015","content":"\n\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\tAt the beginning of June, Nanolek experienced staff changes at the level of top management: Vladimir Khristenko stepped in as new President of the Company. The CEO's position is still held by Mikhail Nekrasov.\n\n<br><br>\n\nBefore getting involved in the pharmaceutical industry, Vladimir Khristenko was employed at the Chelyabinsk Pipe Rolling Plant (CPRP), where he worked his way upward from the project manager until he became Director of Group's Service Division and Chairman of the Board of CPRP-KTS. Vladimir Khristenko <a href=\"https://www.rbc.ru/economics/22/02/2013/570403ec9a7947fcbd445fd0\">joined</a> the Nanolek team as investor in early 2013. Together with the owner of Epidbiomed Group Mikhail Nekrasov he controls 50.01% of company's shares, RUSNANO holds 49.99% of the shares in the project.\n\n<br><br>\n\n\"I lost interest in watching the company's growth from one report to another, that is why I'm in the team now,\" said Vladimir Khristenko while commenting on his appointment. Currently, at Nanolek he is responsible for the strategic development of the company, portfolio construction and cooperation with partners.\t\t\t\t\t\n\t\t\t","source":""}]