Apr. 27 (NBD) -- Two 9-valent Human Papillomavirus (HPV) vaccines against cervical cancer is expected to be available in China in early 2019.

According to public information released Monday on the website of the Center for Drug Evaluation under the China Food and Drug Administration (CFDA), the center has accepted the application submitted by the global pharmaceutical company Merck & Co. Inc. (Merck) to sell two 9-valent HPV vaccines in China. The application will go through fast-track review procedure if no objection is raised within five workdays since information disclosure.

The vaccines are expected to gain the approval by the end of 2018 and hit the Chinese market in early 2019, Pacific Securities said in a report.

When reached for comments by NBD, Merck expressed the company's appreciation towards the support from Chinese government and said it awaits further progress.

Imports of 9-valent vaccines will better serve Chinese customers as such vaccine protects against more HPV sub-types than the 2-valent and 4-valent vaccines.

According to a report compiled by Founder Securities, China has a market for vaccines against cervical cancer worth of 35 billion yuan (5.5 billion U.S. dollars) based on the number of people suitable for vaccination and a market penetration rate of 10 percent, and the market would worth over 100 billion yuan (15.8 billion U.S. dollars) if a 30-percent penetration rate is considered.

However, in contrast to the huge market, only a few HPV vaccines are available in China and it takes a comparably long time for a new vaccine to gain CFDA approval.

Currently, two HPV vaccines dominate China's market, GlaxoSmithKline’s (GSK) Cervarix 2, which protects against two HPV sub-types and Merck’s Gardasil 4, which protects against four.

It had been 10 years before GSK gained the CFDA approval for its HPV vaccine Cervarix 2 in July, 2016, introducing the first HPV vaccine against cervical cancer into China.

Later in May, 2017, Merck's 4-valent HPV vaccine Gardasil was brought into Chinese market via a distributor.

It's noticed that the approval process has been sped up over the years. Taking Gardasil 9 for example, Merck applied for clinical trials in May, 2015, obtained the clinical approval in November, 2017, and submitted the application to sell the vaccine in April this year.

Facing great market potential, China's domestic institutions have also taken corresponding moves. 9-valent HPV vaccines against cervical cancer developed separately by Shanghai-based Mab-Venture, Xiamen University and Yunnan Walvax Biotechnology, have been approved for clinical trials.

Email: gaohan@nbd.com.cn