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When the domestic nine-valent HPV vaccine race is underway: these companies' vaccines have entered the clinical phase III stage

 Last Update: 2022-10-25
 Source: Internet
 Author: User

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Shell financial reporter learned that the HPV nine-valent vaccine under Watson Biologics, Wantai Biologics, Shanghai Bowei, Kangle Guard, and Rico Biologics has entered the third phase of clinical trials
.

With the successive launch of domestic bivalent HPV vaccines under Wantai Biologics and Watson Biologics, the harvest period of domestic bivalent HPV vaccines has arrived, and the nine-valent HPV vaccine track is still racing
.
How is the R&D progressing of the companies involved today?

On August 30, Merck announced that its nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) (hereinafter referred to as nine-valent HPV vaccine) has been approved by China's National Medical Products Administration, which marks the expansion of Merck's nine-valent HPV vaccine to women
aged 9-45.

The bivalent, quadrivalent and nine-valent HPV vaccines can all prevent HPV16 and 18 infections (the two main HPV types that cause cervical cancer, which together cause about 70% of cervical cancer), the quadrivalent HPV vaccine can also prevent HPV6 and 11 infections (which together cause about 90% of genital warts), and the nine-valent HPV vaccine can also provide protection against another 5 high-risk HPV infections (the five high-risk HPVs together cause about 20% of cervical cancer) than the quadrivalent HPV vaccine
。

At present, domestic vaccine companies are still accelerating the research and development
of HPV quadrivalent and nine-valent vaccines.
Shell financial reporter learned that the HPV nine-valent vaccine under Watson Biologics, Wantai Biologics, Shanghai Bowei, Kangle Guard, and Rico Biologics has entered the third phase of clinical trials
.

According to the announcement of Watson Biologics on September 8, the nine-valent HPV vaccine independently developed by Shanghai Zerun, a holding subsidiary, officially launched the first subject enrollment of the "phase III clinical trial comparing the immunogenicity of recombinant human papillomavirus nine-valent vaccine and Gardasil9", marking that the vaccine has officially entered the phase III clinical research stage
.
According to the relevant requirements of China's drug registration, Shanghai Zerun nine-valent HPV vaccine needs to complete the phase III protective efficacy clinical trial in the future, and can only apply for marketing authorization of this vaccine after obtaining the clinical trial report, and can only be produced and sold
after being reviewed and approved by the relevant departments of drug registration and supervision.

On September 27 this year, Wantai Biotech also said in an investor relations event that the company's research and development progress of the nine-valent HPV vaccine is in a leading position in China, and the current phase III clinical trials and industrialization are progressing smoothly
。 Subjects with the nine-valent HPV vaccine have completed three doses of vaccination and are being followed up according to the clinical protocol and collecting cases of persistent infection for 12 months; The head-to-head clinical trial with Jiadaxiu 9 has completed the clinical trial site and specimen testing, and is conducting statistical analysis of data; The young age bridging clinical trial completed the enrollment work; The construction of commercial production workshop has been completed, and the research
on industrialization and scale-up production is underway.

So, after the domestic nine-valent HPV vaccine is on the market, will it affect the market of domestic bivalent HPV vaccine?

In response to the question on September 27, Wantai Biotech said, "This situation
will occur after the nine-valent HPV vaccine is marketed.
China's HPV vaccine market is large enough, but limited by a variety of factors, bivalent HPV vaccine still has a lot of market space
.
"First, the nine-valent HPV vaccine process is more complicated, and production capacity cannot be expanded rapidly; Second, from the perspective of cervical cancer prevention, about 84.
5% of cervical cancers in China are related to HPV16 and 18 types, in response to the WHO 2030 global strategy to eliminate cervical cancer, in the case that the production capacity of nine-valent HPV vaccine cannot meet the requirements, bivalent HPV vaccine is the focus of
government procurement.
”

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