Drug Regulator Gives Green Light to First HPV Vaccine on Mainland Market
(Beijing) – The China Food and Drug Administration has approved the first human papillomavirus (HPV) vaccine to be sold on the mainland after six years of clinical trials, giving men and women a way to protect themselves from several types of cancers caused by a common sexually transmitted virus.
British drug maker GlaxoSmithKline (GSK) said in a statement on July 18 that the Chinese government has given it permission to sell its HPV vaccine, Cervarix, on the mainland, which will hit store shelves as early as the beginning of 2017.
The company said it is working with the government to increase access to this preventive immunization option for women up to age 25. "To achieve this, we are ready to explore an innovative pricing approach to support the inclusion of Cervarix into public cervical cancer immunization programs," Hervé Gisserot, GSK's general manger in China, said in the statement.
Market analysts estimated that the price for the three doses included in the inoculation regimen that was not mandatory, will be capped below 1,000 yuan, or US$ 149.
HPV is a common sexually-transmitted virus, according to the Centers for Disease Control and Prevention in the United States, and it can result in cervical, vaginal and vulvar cancers in women and penile cancer in men.
Cervical cancer is the second most common cancer among women in China after breast cancer, according to a report released by the Cancer Hospital under the Chinese Academy of Medical Sciences earlier this year. Around 30,500 women died of the condition in 2015 and almost 99,000 new cases were diagnosed, the report said.
The first-ever HPV vaccine was introduced to the market in the United States in 2006. In recent years, individuals from the mainland have bought vaccination packages on e-commerce sites and traveled to nearby countries and regions such as Hong Kong to get immunized. Taobao, owned by Internet conglomerate Alibaba Group Holding Ltd., offers HPV vaccination packages from Hong Kong clinics with prices starting from 2,000 yuan, a Caixin editor found.
Cervarix, along with another product, Gardasil, developed by Merck & Co. Ltd., are the only two HPV vaccines available in the global market. GSK started its clinical trials on thousands of subjects on the mainland in 2010 and the efficacy rate of its product is consistent with its global data, the company said.
Merck also started clinical trials on the mainland in 2009. State-run People's Daily reported that the drug maker had submitted its findings to the CFDA for a license in 2013, but the regulator is yet to give its decision. The newspaper citing Qiao Youlin, a professor with the Chinese Academy of Medical Sciences, said the delay may be because Merck's sample size was too small.
Three domestic companies – Walvax Biotechnology Co. Ltd., Xiamen Innovax Biotech Co. Ltd. and Zhejiang Pukang Biotechnology Co. Ltd. – have also applied to conduct clinical trials for HPV vaccines. Once homegrown vaccines enter the market, the price will come down drastically, market analysts said.
(Rewritten by Chen Na)
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