Nanolek has registered Pnevnanol 23, a 23-valent polysaccharide vaccine for the prevention of pneumococcal disease. It is the second 23-valent pneumococcal polysaccharide vaccine registered in Russia. Pnevnanol 23 is indicated for adults aged 50 years and older, as well as children aged 2 to 18 years and adults at increased risk of pneumococcal infections.

Pneumococcus can cause common respiratory diseases, including pneumonia, otitis media and sinusitis, as well as severe invasive infections such as meningitis, bacteremia and sepsis. Pneumococcus is the most common cause of community-acquired pneumonia in adults, accounting for 30-50% of cases with an identified etiology*.

Pnevnanol 23 contains polysaccharides from 23 serotypes of Streptococcus pneumoniae (pneumococcus). The vaccine completed a full cycle of clinical trials in Russia and China. The study results demonstrated comparable immunogenicity, safety and tolerability to the registered Pneumovax 23 vaccine.

Nanolek is bringing the product to the Russian market in partnership with one of China’s leading vaccine developers and manufacturers. “We have taken another step in expanding Nanolek’s vaccine portfolio. Following registration, our priority is to bring the product to the Russian market. We plan to begin supplies of the Pnevnanol 23 vaccine in the fourth quarter of 2026,” said Evgeny Barinov, CEO of Nanolek.

As part of the Russian registration process for Pnevnanol 23, an EAEU GCP inspection of the clinical trial conducted in China was successfully completed. It was the first inspection of this kind by an EAEU regulator conducted in the country.

“The inspectors assessed on site whether the study conducted in China complied with EAEU Good Clinical Practice requirements. Importantly for us, the experience gained can also be applied to future joint projects,” said Maya Benashvili, Medical Director at Nanolek.

Influenza can increase the risk of secondary infections, including pneumococcal disease. Pneumococcal immunization is carried out year-round, while autumn traditionally coincides with the influenza vaccination season.

“Pnevnanol 23 was registered ahead of the seasonal rise in acute respiratory viral infections and bronchopulmonary infections — a period when timely vaccination against influenza and pneumococcal disease is particularly important. Importantly, both vaccinations can be administered during a single visit,” said Elena Stukun, Deputy CEO of Nanolek.

Pnevnanol 23 is supplied as a ready-to-use solution for intramuscular administration — one 0.5 mL dose in a prefilled syringe.

*Clinical Guidelines “Community-Acquired Pneumonia in Adults,” 2024