Russia’s first quadrivalent human papillomavirus (HPV) vaccine, Cegardex*, has been awarded the “Made in Russia” certificate in the “Reliability” category. The certificate confirms that the product’s development and manufacturing meet high standards and enables the vaccine to be promoted for export under the national brand managed by the Russian Export Center (REC). The program is coordinated by the Russian Ministry of Industry and Trade.

Cegardex is a development of Russian scientists. Full-cycle manufacturing — from antigen production to the finished dosage form — is carried out at the Nanolek Biomedical Complex in the Kirov region. The first production line for the HPV vaccine was officially opened on October 29, 2025. The first commercial batches are expected to enter civilian circulation in the second half of 2026.

The launch of Cegardex production is an important step in strengthening the national system for preventing HPV-associated diseases. The vaccine will address the current needs of the Russian healthcare system and has strong export potential.

“Many countries are expanding their HPV vaccination programs. We have everything necessary to enter this market with a strong position: full-cycle production, a modern technological base, and adherence to international quality standards,” said Nanolek CEO Evgeny Barinov.

Cegardex protects against the four most common and dangerous HPV types — 6, 11, 16, and 18. These types are associated with cervical cancer, anal cancer, and skin growths such as papillomas.

Multicenter clinical trials were conducted at leading medical institutions, including: Kirov State Medical University, the Eco-Safety Research Center (St. Petersburg), Perm State Medical University named after E. A. Wagner, and the Medical and Sanitary Unit No. 163 of the FMBA of Russia**.

In March 2025, Cegardex received marketing authorization for use in adults. Clinical studies involving children have been completed, with 402 volunteers aged 9 to 17 participating***. Extension of the indication to this age group is expected in February 2026.

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

**https://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=c5e8a4d8-7b6b-4988-a422-a86a9831332a&CIPermGUID=d50e00bb-d75e-4cbb-9460-a547bbe04897

***https://grls.rosminzdrav.ru/CIPermissionMini.aspx?CIStatementGUID=9eb5d93f-0af1-4733-b60d-0f40d6e8d272&CIPermGUID=186b7fb6-8043-4bf1-82f8-9afe26d24dce