The domestic nine-valent HPV vaccine race is underway: These companies' vaccines have entered the clinical phase three stage

HPV 9-valent vaccines from Watson Biological, Wantai Biological, Shanghai Bowei, Kangle Guardian and Reco Biological are all in Phase III clinical trials.

The harvest period for the domestic bivalent HPV vaccine has now arrived with the marketing of the domestic bivalent HPV vaccine from Wantai Bio and Watson Bio, while the nine-valent HPV vaccine track is still in the race. How is research and development going today?

Merck Sharp and Dohme (MSD) announced on August 30 that its 9-valent human papillomavirus vaccine (Saccharomyces cerevisiae) (9-valent HPV vaccine) has been approved by the National Medical Products Administration of China for its new indication. The approval marks the expansion of the vaccine to women ages 9-45.

The bivalent, quadrivalent, and 9-valent HPV vaccine all protect against infection with HPV16 and 18 (the two main types that cause cervical cancer, which together cause about 70% of cervical cancer cases). The quadrivalent HPV vaccine also protects against infection with HPV6 and 11 (which together cause about 90% of genital warts). It also protects against infection with five additional elevated-risk HPV types (which together cause about 20% of cervical cancers).

Currently, domestic vaccine companies are still accelerating the research and development of HPV quadrivalent and nine-valent vaccines. Watson Biological, Wantai Biological, Shanghai Bo Wei, Kangle Guardian and Reco Biological's HPV 9-valent vaccine has reached the clinical phase III stage, Shell Financial reporters have learned.

According to the announcement of Watson Biology on September 8, the nine-valent HPV vaccine independently developed by Shanghai Zeron, a holding subsidiary, officially started the enrollment of the first subject in the phase Ⅲ clinical trial of immunogenicity comparison between recombinant human papillomavirus nine-valent vaccine and Gardasil9, marking the official entry of the vaccine into the phase Ⅲ clinical study stage. According to the relevant requirements of drug registration in China, the phase Ⅲ efficacy clinical trial of Shanghai Zerun 9-valent HPV vaccine should be completed. The marketing license for the vaccine can only be applied for after clinical trial reports are obtained.

On Sept 27 this year, Wantai Bio also said at an investor relations event that the development progress of the company's 9-valent HPV vaccine is leading the way in China, with Phase III clinical trials and industrialization progressing smoothly..Subjects who had received three doses of 9-valent HPV vaccine were followed up according to clinical protocol and cases of persistent infection were collected for 12 months..The head-to-head clinical trial with Jiada Xiu 9 has completed clinical trial site and specimen testing, and statistical analysis of the data is ongoing..Enrollment in the younger-age bridging clinical trial was completed;;It has completed the construction of commercial production workshops and is conducting research on industrializing and scaling up production.

Thus, will the introduction of the domestic 9-valent HPV vaccine affect the domestic bivalent HPV vaccine market?

In response to questions on September 27, Wantai Biological said, "This situation will occur after the 9-valent HPV vaccine is marketed. China's HPV vaccine market is large enough, but limited by a variety of factors, there is still a lot of market space for bivalent HPV vaccine." "First, the process of 9-valent HPV vaccine is more complex, and production capacity cannot be expanded rapidly. About 84.5 percent of cervical cancers in China are associated with HPV16 and HPV18. In response to the WHO global strategy to eliminate cervical cancer by 2030, the bivalent HPV vaccine is the focus of government procurement when the production capacity of 9-valent HPV vaccine cannot meet the requirements."