Sinovac Files NDA for EV71 Vaccine, Filing Accepted by Beijing Drug Administration
Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced Sinovac's new drug application (NDA) for its proprietary EV71 vaccine has been filed and accepted by the Beijing Drug Administration. In terms of next steps for the NDA review process in China, the Beijing Drug Administration will conduct an on-site inspection on the circumstances of Sinovac's clinical trials and submit its on-site inspection opinion along with the application documentations to Centers for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) for further review and evaluation.
In March 2013, Sinovac completed the Phase III clinical trial for its EV71 vaccine candidate and reported preliminary top-line data that showed approximately 95% efficacy rate for the vaccine against HFMD caused by enterovirus 71 (EV71). Throughout the three phases of the clinical trials, the results demonstrated a good safety, immunogenicity and efficacy profile for Sinovac's proprietary EV71 vaccine candidate. In China in 2012, 2.16 million cases of EV71 were reported along with 560 EV71 related fatalities in 2012.
In parallel, Sinovac's dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by CFDA.
Dr. Weidong Yin, Chairman, President and CEO,