By 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.

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.

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.

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. We continue to evolve as part of our mission to protect lives and health by making the world’s best technologies available.”

Now, for Nanolek, the goal of tripling the vaccine portfolio means adding at least four more vaccinations.

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.

Pneumococcal vaccine. Clinical trials have been completed, and a 13-valent pneumococcal vaccine is scheduled to hit the market next year.

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.

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.
Facts about Nanolek

• 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.
• 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.
• 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, Aspen, and other companies.
• 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.
• Last year, Nanolek showed a multiple of turnover growth: 12 billion rubles in 2020 up from 7.5 billion rubles in 2019.
• 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.
• 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.