FIGURES

·            In 2020, the company’s earnings totalled appr. RUB 12 bn, which is 60% higher than in 2019 (RUB 7.5 bn).

·            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.

·            The investment volume amounted to more than 828 million rubles, which is 66% higher than in 2019 (500 million rubles).

·            8 new market authorization registration certificates were received (4 in the Russian Federation, 2 in the Republic of Belarus and 2 in Uzbekistan).

Partnerships

·               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).

·               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.

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”.

·               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.

·               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.

·               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.
This cooperation is expected to become the first step on the pathway of successful partnership between fundamental science and state-of-the-art production.

Vaccine business

·               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.

·       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).

·               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®) 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.

Contract manufacturing

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.

Cost-demanding nosologies (VZN)

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.

COVID-19

NANOLEK, being a socially responsible company, took an active part in the fight against the pandemic.

·               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.

·               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.

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“.

·               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.

·               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.

New market authorizations

·               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.

·               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.

·               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.

Awards

·               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.

·               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.

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.

Vladimir Khristenko was included in the Top 250 Managers list (by industry). Maksim Stetsyuk is in the Top-100 Commercial Directors list (by industry)”.

·               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.”

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.

·               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”.

·               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).

·               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.

·               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”.

·               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.

·               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.

·               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.

Corporate social responsibility

·               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.

·               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.

·               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.

·               NANOLEK is actively involved in charitable activities and provides assistance in accordance with the regulation on charitable activities:

- provision of financial, social, volunteer and other assistance to people with disabilities (e.g., foundations, orphanages);

- assistance in solving health issues (e.g., foundations, orphanages, medical institutions, etc.);

- support of projects in the field of science and culture;

- assistance to the leading specialized higher and other educational institutions.

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.