HPV Vaccine Competition Expands into Male Indications as Chinese Biotechs Race for Market Share

Beijing News (Reporter Wang Kala) The competition for the nine-valent HPV vaccine is becoming increasingly fierce, expanding from female indications to male indications. On November 19, WANTAI BioPharm announced that its investigational nine-valent HPV vaccine for male indications has been approved for clinical trial application. Although WANTAI BioPharm is leading in the female indications of domestically produced nine-valent HPV vaccines, it is late in the research and development of male indications. In addition to MSD's nine-valent HPV vaccine for male indications, which has already been submitted for marketing approval and accepted by the National Medical Products Administration, the nine-valent HPV vaccines for male indications from Health Guard and Shanghai Bovax Biotechnology Co., Ltd. have also entered clinical trials long ago. In the Chinese market, the race for the nine-valent HPV vaccine for male indications has already begun.

According to data from WANTAI BioPharm's announcement, globally, there are approximately 70,000 new cancer cases in men each year associated with HPV infection, mainly including penile cancer, anal cancer, oropharyngeal cancer, and other head and neck cancers. Among these cancers, about 80% can be attributed to HPV16/18, and approximately 90% can be attributed to HPV6/11.16/18/31/33/45/52/58。

WANTAI BioPharm's nine-valent HPV vaccine covers seven high-risk types: HPV16/18/31/33/45/52/58, and two low-risk types: HPV6/11. It is suitable for preventing genital warts, penile/perineal/anal cancers and their precancerous lesions, anal cancer and its precancerous lesions, and other related indications caused by HPV6/11/16/18/31/33/45/52/58.

In August this year, WANTAI BioPharm's nine-valent HPV vaccine submitted an application for marketing authorization, which has been accepted by the National Medical Products Administration (NMPA) and proposed for priority review. The indication is for the prevention of HPV6 and HPV11 infections and related diseases such as genital warts.Associated with HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58 infections, as well as cervical cancer and other diseases caused by these infections, targeting the female population.

In terms of female indications, WANTAI BioPharm's nine-valent HVP vaccine has a leading advantage among domestically produced vaccines of the same kind in China and may become the first domestically produced nine-valent HPV vaccine to be approved for marketing. In addition to WANTAI BioPharm, the nine-valent HPV vaccines from Health Guard, Shanghai Bovax Biotechnology Co., Ltd., and Ruike Biotechnology have also entered Phase III clinical trials.

However, WANTAI BioPharm has been late in the development of male indications.

MSD's Nine-Valent HPV Vaccine (Gardasil 9) Male Indication Has Been Submitted for Marketing Approval in China. As the world's first nine-valent HPV vaccine, Gardasil 9 had already been approved abroad for male indication, with the vaccination age range covering males aged 9-45. More than a hundred countries or regions worldwide have approved the use of HPV vaccines for males. According to the Dingxiangyuan Insight database, in October 2021, MSD first publicly initiated a project in China.ⅢPhase clinical trial to evaluate the protective efficacy, immunogenicity, and safety of Gardasil 9 in Chinese males. In August 2023, the marketing application for the male indication of Gardasil 9 was submitted and accepted in China.

Shanghai Bovax Biotechnology Co., Ltd.'s nine-valent HPV vaccine is the first domestically produced nine-valent HPV candidate vaccine in China to enter Phase III clinical trials. In September 2022, Bovax Biotechnology initiated a Phase I clinical trial of its recombinant nine-valent HPV vaccine for male indications, targeting healthy Chinese males aged 9-45.

Health Guard's nine-valent HPV vaccine is the first in China to begin trials on males.Key Efficacy TrialThe Phase III clinical trial for the male indication of a nine-valent HPV candidate vaccine produced in China was launched in December 2022. Health Guard expects to complete all subject follow-ups for this clinical trial and submit an application for market approval by the end of 2027.

In terms of raising awareness among men about HPV vaccination, there is still a need for broader education in the Chinese market to enhance men's willingness to get vaccinated and increase market acceptance for this indication. For MSD, although it is the first company to submit an application for the male indication of the nine-valent HPV vaccine in China, domestic vaccines are catching up at a notably faster pace compared to the female indication. It is foreseeable that the competition in the male indication market for HPV vaccines will be exceptionally fierce in the future.

Proofread by Mu Xiangtong