On November 18, Wantai Bio released an announcement stating that it has obtained approval from the National Medical Products Administration to conduct clinical trials for the indications of the nine-valent HPV vaccine for males.

Wantai Bio pointed out that among the male population worldwide, about 70,000 new cancer cases are related to HPV infection each year, such as penile cancer, anal cancer, oropharyngeal cancer and other head and neck cancers. Of these cancers, about 90% can be attributed to polytypes of HPV6, 11, 16, 18, etc. Wantai Bio's nine-valent HPV vaccine covers these viruses and can prevent precancerous lesions caused by these HPV viruses.

With the saturation of the female market space, coupled with several rounds of internal competition for domestic HPV vaccines, even Merck's nine-valent HPV vaccine has shown a decline this year. In the first half of 2024, Merck's global sales of HPV vaccines increased by only 7% year-on-year, of which the second quarter saw an increase of only 1%. The performance of domestic HPV vaccine manufacturers such as Wantai Biological and Watson Biological is even more terrible.

The use of HPV vaccine in men is not a very advanced move. As early as 2021, Merck launched a phase III clinical trial in China to evaluate the protective efficacy, immunogenicity and safety of its nine-valent HPV vaccine in men. Last September, Merck's application for listing of the nine-valent HPV vaccine in China for male indications was accepted. According to market news, the male indication of Merck's nine-valent HPV vaccine is expected to be approved in the fourth quarter of this year, and some offline community service stations have begun to register for appointments.

Wantai Biological is not the first to do male indications. In September 2022, Bowei Bio has already launched a phase 1 clinical trial of the nine-valent HPV vaccine for the male population, targeting healthy Chinese men aged 9-45. Kangle Guard is making faster progress. At the end of 2022, Kangle Guard launched a phase III clinical trial of the nine-valent HPV vaccine for male indications. Kangleweisheng disclosed that it is expected that by the end of 2027, the clinical trial will complete the follow-up of all subjects and submit an application for listing.

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