Merck's 9-valent HPV Vaccine Gardasil 9 Approved in China for Prevention of HPV Infection in Males
MSD
Pharmaceutical R&D and Manufacturer
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On April 14, MSD's Nine-Valent Human Papillomavirus Vaccine (Saccharomyces cerevisiae)-V503(Product name: Gardasil 9)Approved for a new indication in China, forPrevention of Human Papillomavirus in Men（HPV）Infection（JXSS2300075/6）。
Screenshot source: Corporate official website
Gardasil 9 is the world's only approved nine-valent HPV vaccine, which was approved in 2014.First FDA ApprovalListed, and has been actively expanding into new indications thereafter.
Screenshot source: Insight database
In April 2018, Gardasil 9For the first timeApproved for marketing in China, the target population for medication has expanded from the initial group of women aged 16-26 to eligible females aged 9-45. In January 2024, the NMPA approved a new two-dose vaccination schedule applicable to females aged 9-14.
Screenshot source: Insight database
According to the Insight database, there are currently 7 companies in China that have entered the nine-valent HPV vaccine market, includingWantai BioThe fastest-progressing one is currently in the application stage for market launch. There are four others.Have entered Phase III clinical trials, respectivelyKang Cunhui、CanSino Biologics、RecoBioAndWalvax Biotechnology。
CanSino BiologicsA multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial on the safety, efficacy, and immunogenicity in Chinese males aged 18-45 was initiated in December 2022.（CTR20223306）；
Bowei BioA Phase III Clinical Trial on Efficacy, Immunogenicity, and Safety in Chinese Male Population Aged 18-45 Years to be Launched in June 2024（CTR20242197）；
Wantai BioNine-valent HPV VaccineMaleIndicationsApproved for clinical use in November 2024(Application No.: CXSL2400580)。