On August 30, Merck announced that the new indication for its nine-valent human papillomavirus vaccine (brewer's yeast) (hereinafter referred to as "nine-valent HPV vaccine") has been approved by National Medical Products Administration. As the first nine-valent HPV vaccine approved in China, the Merck nine-valent HPV vaccine was previously indicated for use in women aged 16-26 years. The nine-valent HPV vaccine is often out of stock as it is only produced by one company in the world. As for China companies, the nine-valent HPV vaccine from Beijing Health Guard Biotechnology, Wantai Biological and Walvax Biotechnology have entered Phase III clinical trials one after another. With the further age expansion of Merck's nine-valent HPV vaccine, the battle for the HPV vaccine market is becoming increasingly contentious.

Age expansion of imported nine-valent HPV vaccine

In April 2018, the National Medical Products Administration granted conditional approval for the launch of the nine-valent HPV vaccine for the prevention of cervical cancer for women aged 16-26 years.

The "price" of the HPV vaccine represents the breakdown of the types of viruses covered by the vaccine, with the higher the price, the more types of HPV virus subtypes are covered. It is understood that the nine-valent HPV vaccine is suitable for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58; cervical intraepithelial neoplasia (CIN grade 1/2/3) and adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; and HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. 31, 33, 45, 52 and 58 causing persistent infection.

In addition to the nine-valent HPV vaccine, Merck has also received approval from the National Medical Products Administration to market the quadrivalent HPV vaccine, which is also the first quadrivalent HPV vaccine approved in China. It is indicated for women aged 9-45 years of age to prevent cervical cancer, precancerous lesions and persistent infections associated with high-risk HPV 16 and 18 virus infections, as well as to prevent low-risk HPV6 and 11 infections and the genital warts they cause.

The expansion of the age group for which the nine-valent HPV vaccine is indicated is another important milestone for Merck in driving innovation in vaccine development," said Zhengqing Li, Senior Vice President of Merck Global and President of Merck China R&D Centre. As the first company in the world to launch quadrivalent and nine-valent HPV vaccines, Merck has over the years continued to explore the potential of HPV vaccines to prevent various diseases in different populations based on rigorous clinical studies and extensive real-world data. "We are currently conducting a number of clinical studies on new indications for the HPV vaccine in China at the same time and hope to help more people benefit as early as possible in the future."