Wantai BioPharma's Nine-Valent HPV Vaccine Approved, a Breakthrough in Cancer Prevention for Men

On November 18, 2024, Wantai Bio-issued an official announcement announcing that the clinical trial of its nine-valent HPV vaccine for the indication of the male population has been approved by the State Drug Administration.

In the global male population, approximately 70,000 new cancer cases are associated with HPV infection each year, including penile, anal, oropharyngeal, and other head and neck cancers. About 90% of these cancer cases can be attributed to high-risk viruses such as HPV6, 11, 16 and 18. Wantai's nine-valent HPV vaccine covers the protection range of these viruses and can prevent precancerous lesions caused by these HPV viruses.

Given the saturation of the female market and the fierce competition among domestic HPV vaccines, the market performance, including the nine-valent HPV vaccine of Moxadon, has shown weakness. In the first half of 2024, Merck's global sales of HPV vaccines increased by only 7% year-over-year, including 1% growth in the second quarter. The performance of domestic HPV vaccine manufacturers such as Wantai Biological and Watson Biological is even more worrying.

The HPV vaccine for men is not an unprecedented innovation. As early as 2021, Merck launched a Phase 3 clinical trial of its nine-valent HPV vaccine in men in China to evaluate the vaccine's protective efficacy, immunogenicity and safety in men. In September last year, Merck's application for the male indication of the nine-valent HPV vaccine was accepted in China. According to market news, the male indication of Mersha East 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 make appointment registration.

Wantai is not the first company to conduct research on male indications. The company has initiated a Phase I clinical trial of the nine-valent HPV vaccine in a male population in September 2022, involving healthy Chinese men aged 9 to 45 years. Cologuard is further ahead, initiating a Phase 3 clinical trial for a male indication of its nine-valent HPV vaccine in late 2022. Connaught Defender revealed that it is expected that by the end of 2027, the clinical trial will complete the follow-up of all subjects and submit the marketing application.