Sinopharm’s Quadrivalent HPV Vaccine Marketing License Application Accepted

July 10, 2024  Source: drugdu 40

"/On July 4, 2024, Sinopharm's application for marketing authorization of quadrivalent recombinant human papillomavirus vaccine (type 6, 11, 16, 18) (Hansenula polymorpha), which was jointly declared by Sinopharm's Chengdu Institute of Biological Products of China Biological and China Academy of Biological Sciences (National Engineering Research Center for Novel Vaccines), was accepted by the State Drug Administration under acceptance No. CXSS2400063, the first domestic quadrivalent HPV vaccine in China.

This is the first quadrivalent HPV vaccine in China, which mainly covers four subtypes of HPV virus, including 6, 11, 16 and 18, and is suitable for preventive vaccination for women aged 18-45.

The vaccine was independently researched and developed by China Academy of Biological Sciences and industrialized and developed by Chengdu Institute of Biological Products, and the two sides jointly conducted clinical research and initiated Phase III clinical trial in May 2018, and obtained a positive recommendation from the interim analysis based on the visit results - "The results reached the preset level of significance ", indicating good safety and efficacy.

Currently, the Phase III clinical trial of the eleven-valent HPV vaccine developed by Chengdu Institute of Biological Products in cooperation with China Academy of Biological Sciences is also proceeding smoothly. The development of the eleven-valent HPV vaccine is in the first echelon of global high-valent HPV vaccine development.



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