Nanolek LLC announces the receipt of a registration certificate for the recombinant quadrivalent vaccine Tsegardex. The vaccine will be the first Russian medicinal product aimed at counteracting such a highly contagious infection as human papillomavirus. The development of Tsegardex vaccine was carried out within the framework of a long-term strategic partnership between Nanolek LLC and CJSC Research and Production Company Combiotech. The technology of antigen biosynthesis and FDF production is protected by patents in the Russian Federation.
The authorisation documents for Tsegardex were received on March, 5th 2025. According to the registration certificate, the single dose of the vaccine is 0.5 ml. The recommended vaccination course consists of 3 doses and is carried out according to the scheme (0-2-6 months): the first dose - on the appointed day; the second dose - 2 months after the first dose; the third dose - 6 months after the first dose. The drug is indicated for use for adults aged 18 to 45 years for the prevention of precancerous genital lesions (cervical intraepithelial neoplasia 1/2/3 degree (CIN), adenocarcinoma of the cervix in situ (AIS), vulvar and vaginal intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VaIN) 1/2/3 degree), anal canal precancerous lesions (anal canal intraepithelial neoplasia (AIN) 1/2/3 degree) caused by human papillomavirus (HPV) types 6, 11, 16 and 18, cancer of the cervix, vulva, vagina and anal canal caused by (HPV) types 16, 18, anogenital warts (condylomas) caused by HPV types 6, 11.
Vaccine trials for adults were conducted in 4 clinical centres in the Russian Federation. Clinical trials of the vaccine are currently underway with healthy children aged 9-17 years. The project is being implemented in line with the key directions of the Strategy for the Development of Immunoprophylaxis of Infectious Diseases until 2035 and the Strategy for the Development of the Pharmaceutical Industry until 2030. Total investments in launching full-cycle vaccine production will amount to more than RUB 2.5bn. ‘Tsegardex’ will be produced at the production site of the company “Nanolek” in Kirov. The company's existing production capacity will make it possible to fully cover the needs of the healthcare system for this vaccine.
Evgeny Barinov, General Director of Nanolek LLC:
- Promoting government policy to counteract highly contagious infectious diseases and creating our own innovative developments in this area are key priorities for our company. The development of the first domestic vaccine against human papillomavirus and its production on the territory of our country fully fulfils the tasks outlined at the state level and will make it possible to expand the availability of the vaccine for the population. It should be noted that this drug will not only be able to meet the current needs of the Russian healthcare system, but also has a wide export potential.