Sinovac Biotech (SVA), a leading provider of biopharmaceutical products in China, 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.
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 ensure product quality, safety and efficacy of the vaccine. After eight 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. We look forward to the broad adoption of our EV71 vaccine in the China market as well as the overseas market to provide a healthier environment for children globally with the protection of our EV71 vaccine."