Merck’s Improved HPV Vaccine Awaits Approval in China

China has begun reviewing Merck & Co. Inc.’s application to sell its most protective vaccine against the human papillomavirus (HPV) on the mainland market.

Gardasil 9, which fights against a sexually transmitted virus that increases the risk of cervical and other cancers, protects against nine HPV sub-types — more than previous versions of the vaccine.

In the U.S., the vaccine is indicated for males and females between the ages of 9 and 26, and helps prevent infection of the virus, not treat existing infections.

Merck’s Gardasil 9 should launch in China in early 2019, investment firm Pacific Securities predicts.

The China market currently features two HPV vaccines: one from Merck, which protects against four types of HPV, and one from GlaxoSmithKline, which protects against two.

The two companies are currently the world’s only HPV vaccines providers. Merck’s HPV vaccines made up 94% of the global market in 2016, according to research firm Evaluate Pharma — though an employee of GSK’s medicine department previously told Caixin that there haven’t been any published studies that compare the clinical efficacy of the different HPV vaccines on cervical cancer during the premalignant period.

After breast cancer, cervical cancer is the most common cancer among Chinese women, according to researchers at the Cancer Hospital in Beijing, a unit of the Chinese Academy of Medical Sciences.

More than 28% of the world’s cervical cancer patients are in China, according to the Chinese Center for Disease Control and Prevention. But China has been late in introducing the vaccine. The drug regulator approved the Merck and GSK products in 2017, a decade after the United States became the first country to introduce it in 2006.

For now the two developers are competing for patients in China. GSK has partnered with the Chinese Preventive Medicine Association for marketing and public awareness, and has cooperated with Alibaba Group Holding Ltd.’s health care unit to offer reservations for vaccination appointments. Merck has secured deals with clinic chains such as Meinian Onehealth Healthcare Holdings Co. Ltd. and iKang Healthcare Group Inc. for vaccination services.

Eight domestic pharmaceutical firms are developing their own HPV vaccines, according to Changjiang Securities. The one most likely to come to market first is from Xiamen Innovax Biotech Co. Ltd., which submitted its product-approval application in November.

Contact reporter Coco Feng (renkefeng@caixin.com)