Replies to post #325 on Sinovac Biotech Ltd (SVA)

[surf1944]

5:29AM Sinovac Biotech files New Drug Application for EV71 vaccine and receives filing acceptance from Beijing Drug Administration (SVA) 3.87 : Co announces its new drug application 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 of China Food and Drug Administration for further review and evaluation.

In parallel, co's dedicated EV71 vaccine manufacturing facility has been completed and is ready for the GMP inspection by CFDA.