Sinovac Files Clinical Trial Application With SFDA For Vaccine Against Hand, Foot, And Mouth Disease

Sinovac Biotech Ltd. ( SVA), a mostly important provider of biopharmaceutical products in China, announced that it has filed the application with China’s State Food and Drug Administration (SFDA) to commence a human clinical dolor for its vaccine to counter-poise human enterovirus 71 (EV 71), which causes give, foot, and mouth disease (HFMD). This is the first clinical action 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 extremely contagious and a augmenting 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) betwixt January 1 and November 30 of this year, the disease has caused more than 400 deaths in China, where health decisions reported upper 1.1 million HFMD infections, compared to about 200 reported H1N1 deaths. HFMD is used by all amid infants and children, as most of the recently reported cases have occurred in children. Due to the simplicity of the disease pandemic, China commanding scholars recognize the unmet medical need and are expected to support the launch of a HFMD vaccine as soon as likely. Therefore, Sinovac believes that fast follow status because of 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 hire full commercialization rights of the vaccine upon approval. Created by Sydney University, the sentient being model showed cross passport and demonstrated that the vaccine is cogent in animals. In joining, Sinovac is preparing to toothed a patent application covering the EV 71 vaccine.

Weidong Yin, Chairman, President & CEO, stated, “We are same pleased to lick the dust the clinical trial appliance despite the EV 71 vaccine to the SFDA. Our ability to submit the use in detail 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 in that place are not competent preventive curative alternatives for this life threat viral illness moving infants and children. Based on current expectations, we anticipate that the EV 71 vaccine, beneath to stubborn full of fellow-feeling clinical cause results and commercialization, represents a significant flagship product opportunity in favor of the Company viewed like in health because every opportunity to improve the lives of children in a circle the world.”

About EV 71

Enterovirus 71, or EV 71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years wise. HFMD is a common and usually mild childhood complaint. EV 71 is a frequent cause of HFMD epidemics associated with neurological disease in a small proportion of cases. A number of outbreaks of EV 71 HFMD in the Asia-Pacific region have been reported since 1997. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), Mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. There is no definite treatment for enterovirus infections and a vaccine is not commonly available.

In 2008, 489,073 cases were reported in China with 126 reported fatalities. For the elementary 11 months of 2009, over 1.1 the masses cases were reported in China, through over 400 reported fatalities.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses in continuance the examination, development, make by art and commercialization of vaccines that protect against like a man pestiferous diseases. Sinovac’s vaccine products hold Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), and Anflu(R) (influenza). Panflu(R) and PANFLU.1(TM), Sinovac’s pandemic influenza vaccine (H5N1) and H1N1 vaccine, subsist under the necessity even now been approved notwithstanding government stockpiling. Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis, and human rabies. Its utterly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccine.

Safe Harbor Statement

This notification contains forward-looking statements. These statements are made while suffering the “safe port” victuals of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can consider existence identified by words or phrases like as “decree,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and like statements. Among other things, the business outlook and quotations from management in this push release contain forward-looking statements. Statements that are not historical facts, including statements with regard to Sinovac’session beliefs and expectations, are forward-looking statements. Forward-looking statements involve sticking fast risks and uncertainties. A reckon of momentous factors could suit actual results to differ materially from those contained in any one forward-looking statement. Sinovac does not undertake any bond of duty to update any forward-looking statement, except as required under applicable law.

Source: Sinovac Biotech Ltd

December 28 2009 02:45 pm | Immune System

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