Today, there are hardly any skeptics who would question the importance of developing domestic pharmaceutical production. The pandemic has shown that the domestic pharmacological industry should not only actively develop, but is already doing it successfully. This is not only about the creation of anticoid vaccines. The Russian scientific and technological base makes it possible to create and produce innovative drugs and vaccines against a number of diseases.
So, in the fall of this year, the Rostec State Corporation, the RUSNANO Group and the pharmaceutical company Ishvan Pharmaceutical signed an agreement on the construction in the Kaluga Region of a unique production complex for the production of “live” and inactivated vaccines. By 2025, the production capacity of the new enterprise should reach 4 million doses of drugs per year. The enterprise will produce, in particular, vaccines for the prevention of rotavirus infection, chickenpox, human papillomavirus (HPV), vaccines against meningococcal infection, for the prevention of measles, mumps and rubella, as well as a monoclonal antibody to the rabies virus.
“The creation of an enterprise for the production of Russian vaccines will contribute to the import substitution of drugs currently supplied exclusively by Western companies,” said Ivan Ozhgikhin, Senior Managing Director of RUSNANO Management Company. In addition, the project implies the creation of a center of scientific competence for research, development and market launch of its own products and technologies in the future, which fully corresponds to the goals and objectives formulated in the strategy of the RUSNANO group as a development institution. “
The enterprise will use the technological processes of the world’s largest vaccine manufacturer, Serum Institute of India, with full localization in Russia. When creating a production facility, the competencies of the State Corporation Rostec will be used in the implementation of large infrastructure projects and the intellectual potential of the RUSNANO Group, including in the provision of scientific expertise.
“The introduction of innovations through the localization of production and transfer of technologies from our partners – the Indian companies Serum and Zaides, as well as a look into the future at mRNA technology will allow the created production to take one of the leading positions in the Russian pharmaceutical market in a short time”, – said director of the company “Ishwan Pharmaceutical” Debadutta Mishra.
Photo: istock
The creation of a unique industrial complex designed using modern high-speed technologies for the production of “live” and inactivated vaccines will be carried out on the basis of one of the facilities of the pharmaceutical company “Pharm Aid Ltd”, located in the industrial park “Vorsino” in the Kaluga region. Pharm Aid Ltd was established in 2017 with the aim of organizing the transfer of technologies for the full production cycle from the Indian technological partners Serum Institute of India and Zaides Kadila.
“The new high-tech production, which we plan to create in the Kaluga region, will produce drugs for the prevention of a whole range of diseases that annually damage the health of thousands of Russian citizens,” said Alexander Nazarov, General Director of RT-Business Development. we hope to quickly launch a modern, high-tech enterprise, which by 2025 will be able to produce more than 4 million doses of vaccines demanded by the national healthcare, and more than 8 million doses in 2026, with the possibility of further increasing production. “
Of course, the development of the domestic pharmaceutical industry is not limited to the production of vaccines. In our country, drugs are already successfully produced that directly affect the quality and life expectancy of the population. Thus, the pharmaceutical company NovaMedica, founded by the RUSNANO Group and the American venture fund Domain Associates LLC, is developing a large portfolio of pharmaceutical products in the field of central nervous system diseases therapy, including a line of seven developments within its own R&D program: two of which are already are registered and are being prepared for launching on the market, and five more are at various stages of registration. These are products for the treatment of insomnia, cognitive disorders, migraines, moderate and severe forms of dementia, as well as for the relief of pain.
Photo: from the archive of the R & D center “NovaMedika Innoteh”
NovaMedica not only develops drugs itself, but also helps its colleagues in the market to create them on a contract basis with the help of the NovaMedica Innotech R&D center opened in Moscow in 2017. Innotech possesses the latest technological capabilities, conducts research, development and production of innovative and effective drugs, in full compliance with GMP standards. The production capacity of the R&D center “NovaMedica Innotech” is up to 120 million medicinal units per year (tablets, capsules, hard gelatin capsules with various fillings). In particular, this year Innotech joined the creation and production of a drug for the treatment of coronavirus infection – Avifavir in partnership with Kromis LLC, a joint venture between the Russian Direct Investment Fund (RDIF) and ChemRar Group of Companies. The transfer of production was carried out as soon as possible. The production volume of Avifavir in Innotech is 100 thousand packages per month.
Photo: Photo from the archive of the R & D Center “NovaMedika Innoteh”
The export potential of Russian pharmaceutical developments is evidenced by Big Pharma’s genuine interest in them. The first product of NovaMedica’s own R&D program this spring “received registration” in the drug portfolio of the Bayer concern. The companies announced a deal under which Bayer received an exclusive 15-year license to commercialize an innovative proctological drug developed by NovaMedica, including its production and marketing. The agreement applies to the whole world except Japan. The Russian developers of the drug managed to combine previously incompatible active substances in the form of a water-soluble gel, thereby achieving both a therapeutic and anesthetic effect, which ensures ease of use and an increase in the quality of life for patients. The drug is already available in Russian pharmacies. As Elena Litvinova, CEO of NovaMedica noted: “We are building our R&D program in the direction of finding non-standard solutions to meet the current needs of patients. This is our profile. And the fact that Bayer has shown interest in our product speaks of recognition of NovaMedica’s inventive competencies and the high importance of developing partnerships for strengthening business. “
Another significant project for the Russian pharmaceutical industry is being implemented at the facilities of the RUSNANO portfolio company in St. Petersburg. PJSC Pharmsintez, in addition to the production of drugs and pharmaceutical substances at its own production facilities in Kapitolovo, is working on several promising projects, including the development of nutrient media for cell cultures, including for the cultivation of cells that produce the Sputnik V vaccine, human genetic engineering neutralizing antibodies against the SARS-Cov-2 virus and for the production of other types of monoclonal bodies. In 2022, the company plans to complete registration and bring several in-demand drugs to the Russian market. These include the world’s only hepatitis B vaccine, Sci-B-Vac®️, which is effective against all three types of hepatitis B surface antigen; a drug (a conjugate of erythropoietin and polysialic acid) intended for the treatment of anemia in patients with chronic kidney disease (CKD); as well as a number of drugs for the treatment of cancer.
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