Sinovac Biotech Announces Issuance of GMP Certificate for EV71 Vaccine

Sinovac Biotech Ltd.

announced today that the China Food and Drug Administration ("CFDA") has issued the Good Manufacturing Practices ("GMP") certificate to Sinovac for the Company's Enterovirus 71 ("EV71") vaccine. This marks the completion of the final step of approval prior to commercial production. The company has begun commercial production of the EV71 vaccine and expects to deliver the vaccine to the market prior to the end of the second quarter of 2016 after the lot release testing is completed. The designed annual production capacity is 20 million doses. As previously announced, the CFDA issued the new drug certificate and production license for Sinovac's EV71 vaccine on December 30, 2015, which was followed by the public notification on the status of the GMP certification starting from January 5, 2016 to January 18, 2016. Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "The issuance of the GMP certificate has allowed us to begin commercial production of the EV71 vaccine. Sinovac has referenced the highest level of domestic and international quality standards throughout the development of the EV71 vaccine candidate and has established stringent controls to