Sinovac Biotech

Sinovac’s EV71 vaccine produces positive phase III clinical trial results

Friday, February 28, 2014

Sinovac Biotech, a provider of biopharmaceutical products in China, has announced that Phase III clinical trial results for its proprietary Enterovirus 71 (EV71) vaccine have been published online in the February 27 issue of TheNew England Journal of Medicine (NEJM). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease (HFMD), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac’s vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

[Read More]

Sinovac files NDA for EV71 vaccine

Tuesday, June 4, 2013

Sinovac Biotech’s NDA for its proprietary EV71 vaccine has been accepted by the Beijing Drug Administration, which will conduct an on-site inspection of Sinovac’s clinical trials and submit its  opinion along with the application documentations to the Centers for Drug Evaluation (CDE) of the China Food and Drug Administration (CFDA) for further review and evaluation.

[Read More]