Sinovac Biotech gets GMP stamp from CFDA for hand, foot and mouth vaccine

Beijing-based Sinovac Biotech ($SVA) has secured its good manufacturing certificate from the China FDA, placing it on track to sell the Enterovirus 71 (EV71) vaccine to prevent hand, foot and mouth disease (HFMD).

The company has navigated stricter manufacturing requirements in China overall and has scaled up to commercial production, according to a press release. It expects to get the vaccine to the market by the end of the second quarter of 2016 from its Beijing production facility, which is capable of producing 20 million doses annually.

The company announced its award of a new drug certificate and production license for EV71 vaccine earlier this month.

"The issuance of the GMP certificate has allowed us to begin commercial production of the EV71 vaccine," said Weidong Yin, chairman, president and CEO of Nasdaq-listed Sinovac, in the press release. "… After 8 years under development, the EV71 vaccine demonstrates the proven capabilities of Sinovac's research and development efforts and significant achievements in the areas of etiology, epidemiology, vaccinology and clinical application. With the clinically-proven strong efficacy profile of our EV71 vaccine, we plan to collaborate with local CDC's to increase the vaccine coverage of this product and reduce the overall number of severe and fatal cases of hand, foot and mouth disease in China."

The vaccine, which is given to children between 6 and 35 months old in two doses a month apart, will not be covered by reimbursement, going through private pay channels at the start.

"Targeting the private pay market enables Sinovac to take full advantage of its existing sales networks, including in-house sales team and third-party distributors, to ramp up EV71 vaccine sales," the company said in early January.

It is the second locally made HFMD vaccine in China after the CFDA in December cleared an EV71 vaccine from the Institute of Medical Biology at the Chinese Academy of Medical Sciences for production.

HFMD has developed into a serious public health threat in China, with children under 5 years of age the most vulnerable. The country counted 2.8 million cases last year, 508 of them ending in death, according to reports.

- here's the release

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