SVA submits the first clinical trial application for HFMD vaccine in China

Dec 28 2009

Sinovac Biotech Ltd. ( SVA), a leading provider of biopharmaceutical products in China, announced today that it 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 HFMD vaccine submitted in China.

No vaccine or antiviral treatment is currently available for HFMD worldwide, though it has become a very serious problem in Asia in recent years. The disease is highly contagious and a growing number of HFMD cases have been reported in parts of Asia, including Mainland China, Hong Kong, Singapore, Korea, and Taiwan. According to China's Center for Disease Control (CDC) between January 1 and November 30 of this year, the disease has caused more than 400 deaths in China, where health authorities reported over 1.1 million HFMD infections, compared to about 200 reported H1N1 deaths. HFMD is common among infants and children, as most of the recently reported cases have occurred in children. Due to the severity of the disease epidemic, China authorities recognize the unmet medical need and are expected to support the launch of a HFMD vaccine as soon as possible. Therefore, Sinovac believes that fast track status for the reviewing process and approval may be granted.

As previously announced, the Company began preclinical development in 2008. 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.

Weidong Yin, Chairman, President & CEO, stated, "We are very pleased to submit the clinical trial application for the EV 71 vaccine to the SFDA. Our ability to submit the application ahead of the projected 2010 timeline is a validation of the R&D capabilities of the team developing this vaccine. A vaccine against EV 71 represents a significant unmet medical need, given that there are not effective preventive therapeutic alternatives for this life threatening viral illness affecting infants and children. Based on current expectations, we anticipate that the EV 71 vaccine, subject to positive human clinical trial results and commercialization, represents a significant flagship product opportunity for the Company as well as an opportunity to improve the lives of children around the world."