Sinovac Files Clinical Trial Application for HFMD in China

Siinovac Biotech, a provider of biopharmaceutical products in China, has filed the application with China's State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). This is the first clinical trial application for a HFMD vaccine that has been submitted in China, according to the company.

Sinovac is independently developing the EV 71 vaccine and will retain full commercialization rights of the vaccine upon approval. Created by Sydney University, the animal model showed cross protection and demonstrated that the vaccine is effective in animals. In addition, Sinovac is preparing to file a patent application covering the EV 71 vaccine.

According to China's Center for Disease Control (CDC) between January 1 and November 30, 2009, the disease has caused more than 400 deaths in the country, where health authorities reported over 1.1 million HFMD infections.