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China has approved for sale the first domestically developed human papillomavirus (HPV) vaccine, making it the first Chinese alternative to internationally produced products on the market.
Chinese biotechnology firm Innovax and Xiamen University co-developed the vaccine, called Cecolin. Currently, only two drug companies—the U.K.’s GlaxoSmithKline and the U.S.’s Merck—are allowed to sell HPV vaccines in the world.
The bivalent vaccine can be used to prevent HPV types 16 and 18 and is suitable for women aged between 9 and 45, China’s National Medical Products Administration said in a notice on its website Tuesday. The notice made no mention of men, whom the virus can also infect.
So far, scientists have found more than 100 types of HPV, with types 16 and 18 considered high-risk and causing 70% of cervical cancers and pre-cancerous cervical lesions, according to the World Health Organization (WHO).
A total of 7,372 women from five Chinese provinces took part in Cecolin’s phase 3 clinical trials, which showed that the vaccine was able to provide 100% prevention against pre-cancerous cervical lesions related to HPV and that 97.8% of the vaccine recipients were invulnerable to persistent HPV infection, Fujian province-based Innovax said on its website.
Innovax also said that it is planning to apply for a WHO permission to sell Cecolin globally. The company is preparing for an initial public offering (IPO) to raise 380 million yuan for vaccine quality improvement and globalization projects.
Contact reporter Ding Yi (yiding@caixin.com)
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