Nanolek has announced the completion of Phase III clinical trials of its Cegardex® human papillomavirus (HPV) vaccine in children. Cegardex is the first domestically developed vaccine for the prevention of HPV types 6, 11, 16, and 18. The Phase III trial was conducted from February 2024 through August 2025 and involved 402 healthy volunteers of both sexes aged 9–17. The results confirmed the vaccine’s efficacy, safety, and good tolerability.*
“The registration dossier for the use of Cegardex in children of both sexes aged nine and older has been submitted to the Russian Ministry of Health. At the same time, we are building a full-cycle HPV vaccine production line at our facility in the Kirov region—from active pharmaceutical ingredient to finished dosage form. Mastering this technology will reduce import dependence and provide the country with a world-class HPV vaccine produced to international GMP standards,” said Nanolek CEO Evgeny Barinov.
Development of the Cegardex vaccine is being carried out in partnership with the research and production company Combiotech. The manufacturing technology is protected by patents in the Russian Federation. The vaccine received its marketing authorization for adult use from the Russian Ministry of Health on March 5, 2025.
Mass production of the HPV vaccine will strengthen the country’s cancer-prevention system by supporting the expansion of the National Immunization Schedule. HPV vaccination protects against precancerous lesions of the anogenital area in both men and women and has been proven to reduce the incidence and mortality of cervical cancer.***
In Russia, cervical cancer ranks second in prevalence among all cancers in women aged 14–45 and is the leading cause of cancer-related death in women under 44. More than 30 percent of patients are diagnosed at stages III–IV, and first-year mortality after diagnosis reaches 11.7 percent.****
Widespread vaccination will help reduce the burden of HPV-associated diseases, preserve women’s reproductive health, and increase birth rates.
*https://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=9eb5d93f-0af1-4733-b60d-0f40d6e8d272&CIPermGUID=186b7fb6-8043-4bf1-82f8-9afe26d24dce
**Multicenter randomized parallel-group comparative study to assess the immunogenicity, tolerability, and safety of a recombinant quadrivalent (types 6, 11, 16, 18) human papillomavirus vaccine in children aged 9–17 years. The study was conducted from February 2024 to August 2025. Unpublished data. Planned publication date: 2026.
***Global strategy to accelerate the elimination of cervical cancer as a public health problem. WHO, 2022.
****State of Oncological Care for the Population of Russia in 2024. Edited by A.D. Kaprin, V.V. Starinsky, A.O. Shakhzadova. Moscow, 2025.