Russian biopharmaceutical company Nanolek has received a registration certificate for Cegardex, a vaccine aimed at preventing human papillomavirus (HPV) infection. This vaccine is an analog of Gardasil, developed by American firm MSD, which was the first HPV vaccine to be introduced globally. Tsegardex is designed to protect against four HPV types — 6, 11, 16, and 18 — that are associated with cervical cancer. Initially, Tsegardex will be administered to adults, although a pediatric formulation is expected to be available within a few years. It is anticipated that this domestically produced HPV vaccine may soon be integrated into the National Calendar of Vaccinations, according to Forbes.
Developed in collaboration with partner NPC Combiotech, Cegardex is a suspension for intramuscular injection, featuring highly purified non-infectious proteins of the listed HPV types. This vaccine aims to prevent diseases linked to these virus types, including cervical cancer, anal cancer, and skin growths known as papillomas.
Notably, Сegardex provides protection against the same HPV types as Gardasil, which has been in use since 2006 and has received approval from various international organizations, including the World Health Organization. Large-scale HPV vaccination programmes have been underway around the world since then. The Nanolek press service informed the publication that within a few years the company will also launch a children’s version of the vaccine.
«A clinical trial of the vaccine in healthy children aged 9-17 years is underway to further expand the age range of the vaccine. The corresponding indications are expected to be included in the vaccine’s registration certificate in 2026», — the press service said, recalling that the Russian vaccine was successfully tested in 2021-2023.
The development of the vaccine was first announced in 2020, with an investment of approximately 1.8 billion rubles allocated for its production, slated to commence by the end of 2023. NPK Combiotech initially patented the vaccine in 2014 and secured a production method patent in 2018. Currently, NPK Combiotech is registered as a manufacturer of the active pharmaceutical ingredients of the vaccine, while Nanolek’s facility in the Kirov region produces the finished vaccine.
In 2024, Nanolek received approval from the Ministry of Health of the Russian Federation for the third phase of a clinical trial of human papillomavirus (HPV) vaccine in 402 children and adolescents aged 9-17 years. This study represents the final phase before the vaccine will enter the Russian market. Researchers compared the safety and efficacy of Cegardex with the American-made Gardasil and found that both vaccines have an identical antigenic composition.
Beyond Gardasil, MSD has a nine-valent HPV vaccine that is not registered or sold in Russia. Another option, Cervarix from British firm GlaxoSmithKline, protects against only two HPV types — 16 and 18 — and enjoys less popularity compared to Gardasil.
According to analytical firm AlphaRM, Russia purchased 30,800 packages of quadrivalent Gardasil for 262 million rubles from the start of 2025. In 2024, spending on this vaccine reached 1.7 billion rubles, with 212,500 packages procured. In retail, 13,500 packages were bought in pharmacies for 123.3 million rubles in 2024, while in 2023, 9,100 packages were sold for 81.4 million rubles. In contrast, purchases of Cervarix in 2024 amounted to 38.5 million rubles, with retail sales accounting for 36.2 million of that figure and the remainder being public procurement.
