Pfizer Submits Clinical Trial Application in China for Its 20-Valent Pneumococcal Conjugate Vaccine PREVNAR 20

On April 1, the CDE website showed that Pfizer's 20-valent pneumococcal polysaccharide conjugate vaccine (PREVNAR 20, PCV20) clinical application has been accepted by the National Medical Products Administration in China.

This product was approved for marketing by the U.S. FDA in June of last year and is marketed under the trade name PREVNAR 20. It is indicated for adults aged 18 years and older to prevent invasive disease and pneumonia caused by 20 serotypes of Streptococcus pneumoniae.

PREVNAR 20 is the upgraded version of Pfizer's flagship product PCV13 (Prevnar 13). In addition to covering the 13 serotypes in PCV13, PCV20 adds seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F), nearly covering the 20 major serotypes of pneumococcal strains responsible for pneumonia outbreaks in the United States and globally.

According to the financial report, PCV13 and PCV20 generated $5.272 billion in revenue for Pfizer in 2021.

According to the PharmaGo database by Medicine Cube, Chinese companies Wantai Bio/JS Kunli are also developing a 20-valent pneumococcal polysaccharide conjugate vaccine.

On January 29, 2021, Wantai Biological and Jiangsu Kunli signed the "License Agreement for the 20-Valent Pneumococcal Vaccine Candidate," transferring (exclusive license) the rights for the production, manufacturing, and sales of the 20-valent pneumococcal polysaccharide-protein conjugate vaccine using pneumolysin as a carrier in mainland China to Wantai Biological. The licensing fee is 20 million yuan, milestone payments total 480 million yuan, and royalties are 6%-8% of net sales.