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.

It was found that cervical cancer (CC) in 66.2% is caused by HPV type 16 and 18, according to independent scientific publications.

According to the World Health Organization, cervical cancer (CC) is only cancer that can be prevented by primary prevention - vaccination against HPV.

In Russia, the economic damage fr om cervical cancer associated with HPV is about 50 billion rubles a year.

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.

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.

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.

Ivan Borisov, President of Combiotech NPK, commented on the signing of the agreement: “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”.

Vladimir Khristenko, President of NANOLEK: “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”.

“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,” noted the Chief of the Moscow Department of Health Alexey Khripunat at the March 4th event dedicated to World HPV Day.

Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation: “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”.

About COMBIOTECH

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).

About NANOLEK

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.

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.

August 14, 2019, Nanolek LLC left the list of RUSNANO portfolio companies.