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.

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.

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.

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.

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.

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.

Currently, the portfolio of the Nanolek R&D centre includes five types of drugs:

●      multivalent vaccine against coronavirus and influenza;

●      shingles vaccine (Herpes Zoster) – the shot is given to 50+ people; in Russia, there is no domestic vaccination of this type yet;

●      two biosimilar monoclonal antibodies;

●      one original monoclonal antibody.

Quotes:

Vladimir Khristenko, President of NANOLEK

“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.”

Vasily Osmakov, first Deputy Minister of Industry and Trade of the Russian Federation

“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.

Yekaterina Zinovieva, Minister of Investments, Science and Industry of the Moscow Region

“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”.

Alexey Vorobyov, head of Pushchino urban district municipality

“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”.

Background Information

Nanolek Biopharmaceutical Company

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.