Sinovac gets China FDA new drug, production nod for HFMD vaccine

Beijing-based Sinovac Biotech ($SVA) has won a China FDA new drug certificate and production license approval for its Enterovirus 71 (EV71) vaccine to prevent hand, foot and mouth disease (HFMD), marking the second go-ahead in the space in a month.

Sinovac had completed GMP inspections with the CFDA in October 2015 at its EV71 vaccine production facility in Beijing that has an annual capacity of 20 million doses.

The formal approval sets up a timetable that should see the Nasdaq-listed company receive the GMP license in early 2016 and launching commercial output immediately, according to a press release.

"The company expects to deliver the vaccine to the market within four to five months after commercial production begins," according to the release.

The treatment is aimed at children between 6 and 35 months old and will require two doses a month apart--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 the release.

"Sinovac's sales and marketing team is actively finalizing the execution plan for the sales strategy of this product."

The availability of two locally made HFMD vaccines in China is considered a boost for local manufacture. HFMD has developed into a serious public health threat in China, with children under five years of age the most vulnerable. The country counted 2.8 million cases last year, 508 of them ending in death, according to reports.

In December, the CFDA cleared an EV71 vaccine from the Institute of Medical Biology at the Chinese Academy of Medical Sciences for production, making it the first such vaccine to get a nod in China.

- here's the release from Sinovac