Sinovac: CFDA Issues New Drug Certificate Production License For EV71 Vaccine

(RTTNews) - Sinovac Biotech Ltd. (SVA), a provider of biopharmaceutical products in China, announced that the China Food and Drug Administration or CFDA issued the new drug certificate and production license for its Enterovirus 71 or "EV71" vaccine.

As previously announced, the CFDA completed its Good Manufacturing Practices (GMP) inspection simultaneously with the site inspection of the EV71 vaccine production facility in October 2015, and will issue the GMP license after the new drug certificate and production license are issued. Sinovac expects to receive the GMP license in early 2016 and will start commercial production of EV71 vaccine immediately afterwards.

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

Sinovac's EV71 vaccine production facility is located in Beijing with an expected production capacity of 20 million doses annually. This vaccine will target children aged 6-35 months, with each child requiring a total of two doses one month apart from another.

The company's EV71 vaccine sales will initially focus on the private pay sector of the Chinese vaccine market. Since its inception in 2001, Sinovac has grown its expertise in China's private vaccine market through selling hepatitis and flu vaccines. 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. Sinovac's sales and marketing team is actively finalizing the execution plan for the sales strategy of this product.