Sinovac issues update on pipeline

Chinese biopharma company Sinovac (Nasdaq: SVA) has issued an update on its pipeline, namely that the EV71 vaccine supplementary documentation has been submitted to the China Food and Drug Administration needed for approval.

The company submitted the supplementary documentation at the end of January as required following review of the new drug application by an expert panel in November 2014, and the CFDA has begun its review of the supplementary documentation. Once Sinovac has received the new drug certificate, production license and GMP license, it will begin commercial production of its EV71 vaccine. EV71 is a virus that causes hand, foot and mouth disease and is the primary cause of most severe and fatal cases of the disease in China.

Its pneumococcal 23-valent polysaccharide vaccine trials are expected to start in the first half of 2015, while the company is preparing supplementary material for the clinical trial application for its varicella vaccine. Sinovac expects to receive this license in 2015. The company obtained its clinical trial license in January 2015 for the pneumococcal 13-valent conjugate vaccine, and is required to commence trials within three years from the license being issued.