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(Yicai) Sept. 8 -- China has accepted Merck Sharp & Dohme’s application for the use of its nine-valent human papillomavirus vaccine in men. The US pharmaceutical company is the world's only 9vHPV vaccine maker.
MSD’s application was accepted by the Center for Drug Evaluation of China’s National Medical Products Administration, the regulator said on its website on Sept. 5. The country has not yet approved any HPV vaccine for use in men.
The specific age groups of men MSD’s jab would be used for still depends on its use being green-lighted, a person familiar with the matter told Yicai yesterday. It is currently used only in women aged nine to 45.
HPV is an extremely common group of viruses, with a rate among men of about 45 percent globally. It can cause reproductive tract infections and has more than 100 varieties.
As of 2020, the country had 344 million men aged nine to 45 and fit to receive around 980 million jabs, according to data from US consultants Frost & Sullivan.
In 2021, New Jersey-based MSD started the third phase of clinical trials in China for the efficiency, immunogenicity, and safety of its HPV vaccine in men.
MSD’s 9vHPV vaccine monopoly may end soon because Chinese firms Walvax Biotechnology, Jiangsu Recbio Technology, Wantai Biological Pharmacy, Beijing Health Guard Biotechnology, and Bowei Biotechnology have started third-phase trials of their own 9vHPV jabs, with some likely to hit the market in 2025.
Health Guard expects its 9vHPV shot for men to be approved in 2028, according to the listing prospectus it filed with the Beijing Stock Exchange in February.
Editor: Martin Kadiev