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."
SOURCE Sinovac Biotech Ltd.