Cegardex, Russia’s domestically produced human papillomavirus (HPV) vaccine manufactured by NANOLEK, has been released for distribution. The first batch of 30,000 doses is expected to reach healthcare facilities at the end of September. Full-cycle vaccine production was launched in October 2025 at NANOLEK’s biopharmaceutical complex in the Kirov Region. The project was implemented with financial support from the federal Industrial Development Fund (IDF).

Cegardex was jointly developed by NANOLEK and NPK Combiotech. The vaccine is manufactured using a full-cycle process, from antigen production starting with the cell bank through to the finished dosage form. Total investment in the project amounts to RUB 7.5 billion, including a RUB 950 million preferential loan provided by the IDF to purchase high-tech equipment.

A second HPV vaccine production line will be launched at the biopharmaceutical complex in 2027. This will enable NANOLEK to scale up output, bringing its HPV vaccine production capacity to more than 3 million doses per year.

Initial orders for the vaccine have already been received from customers in the Magadan, Kirov, Kaliningrad, Murmansk and Moscow regions, Krasnoyarsk Krai, and other parts of Russia. Major private clinics have also expressed interest in the first batch. Sales have already begun, with initial deliveries expected at the end of September.

“The start of deliveries of Russia’s first domestically produced HPV vaccine manufactured through a full-cycle process marks a new stage in strengthening the country’s pharmaceutical security and expanding access to vaccination. Until now, the Russian market has been entirely dependent on imports. Domestic production allows us to reverse this trend and provide reliable protection against dangerous HPV types. The initial batch of 30,000 doses has already been released for distribution, and 600,000 doses will be produced by the end of the year,” said Evgeny Barinov, CEO of NANOLEK.

At the same time, the company is working to introduce the vaccine in other countries. In the first half of 2026, Cegardex’s registration dossier was submitted for marketing authorization in Belarus, Kazakhstan, Armenia and Kyrgyzstan. Marketing authorizations in these countries are expected between late 2026 and the first quarter of 2027.

Cegardex' is Russia’s first quadrivalent HPV vaccine. It protects against HPV types 6, 11, 16 and 18. The vaccine is approved for use in children and adults aged 9–45.

HPV vaccination protects against precancerous lesions of the anogenital region in men and women and has been shown to reduce cervical cancer incidence and mortality. In Russia, cervical cancer is the second most common cancer among women aged 15–44 and the leading cause of cancer-related death among women under 44. More than 30% of cases are diagnosed at stages III–IV, and mortality within the first year after diagnosis reaches 11.7%''. Widespread vaccination will help reduce the burden of HPV-associated diseases, preserve women’s reproductive health and increase birth rates.

'https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=28c34cae-5bcb-4795-9417-1264be63b56f

''State of Cancer Care in Russia in 2024. Edited by A. D. Kaprin, V. V. Starinsky and A. O. Shakhzadova. Moscow, 2025.