Sinovac Receives Notification of China Government Grant for EV71 Vaccine
RMB 60 Million Free Grant for Construction of Dedicated Production Facility
BEIJING, April 24, 2014
BEIJING, April 24, 2014 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a
leading China-based vaccine manufacturer, announced today that it has received
notification that a RMB 60 million free government grant has been approved by
China's Ministry of Finance, National Development and Reform Commission,
Ministry of Industry and Information Technology, and National Health and
Family Planning Commission for construction of the Company's dedicated
production facility for its Enterovirus 71 (EV71) vaccine against hand foot
and mouth disease (HFMD). Given the severity of HFMD epidemic levels in China
and the government's focus on developing the biotechnology industry, Sinovac's
EV71 vaccine commercial production project was approved as one of the projects
supported by the Dedicated Funds for Strategic New Emerging Industry
Development. The funding criteria as outlined in this grant are to complete
the construction of its production facility in compliance with China's new GMP
guidelines with an annual capacity of 20 million doses of EV71 vaccine and to
commercialize the vaccine in China. The grant will be funded in several
tranches, of which RMB 20 million will be provided within the year, and the
remaining will be provided after the criteria are met.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "From 2007
to 2013, over 9 million cases of HFMD have reported in China with
approximately 2,700 reported fatalities. This epidemic situation represents a
significant unmet medical need for the EV71 vaccine. With the government
support for building out the dedicated production capacity, Sinovac is poised
to provide the EV71 vaccine to help address this potentially fatal childhood
disease for which no commercialized vaccine and no EV71 specific treatment
exist. The grant provides the confidence and encouragement that EV71 vaccine
is urgently needed and has attracted the attention from the Chinese
government. We look forward to working with the regulatory agencies to
complete the vaccine registration process as soon as possible."
In March 2013, Sinovac completed the Phase III clinical trial for its EV71
vaccine candidate and reported preliminary top-line data that showed
approximately 95% efficacy rate for the vaccine against HFMD caused by
enterovirus 71 (EV71). Throughout the three phases of the clinical trials, the
results demonstrated a good safety, immunogenicity and efficacy profile for
Sinovac's proprietary EV71 vaccine candidate. In May 2013, Sinovac's new drug
application (NDA) for its proprietary EV71 vaccine has been filed and accepted
by the China Food and Drug Administration ("CFDA"). Currently, the NDA is
under the technological review by Centers for Drug Evaluation.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses
on the research, development, manufacturing and commercialization of vaccines
that protect against human infectious diseases including hepatitis A and B,
seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine
flu) and mumps, as well as animal rabies vaccine for canines. The Company
recently concluded the phase III clinical trial for enterovirus 71 (against
hand, foot and mouth disease) and filed new drug application with China Food &
Drug Administration. In 2009, Sinovac was the first company worldwide to
receive approval for its H1N1 influenza vaccine, Panflu.1, and has
manufactured it for the Chinese Central Government, pursuant to the
government-stockpiling program. The Company is also the only supplier of the
H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac
is developing a number of new pipeline vaccines including vaccines for
pneumococcal polysaccharides, pneumococcal conjugate, varicella and rubella.
Sinovac sells its vaccines mainly in China and exports selected vaccines to
Mongolia, Nepal, and the Philippines. Sinovac has also been granted a license
to commercialize seasonal flu vaccine in Mexico.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are
made under the "safe harbor" provisions of the U.S. Private Securities
Litigation Reform Act of 1995. These forward-looking statements can be
identified by words or phrases such as "will," "expects," "anticipates,"
"future," "intends," "plans," "believes," "estimates" and similar statements.
Among other things, the business outlook and quotations from management in
this press release contain forward-looking statements. Statements that are not
historical facts, including statements about Sinovac's beliefs and
expectations, are forward-looking statements. Forward-looking statements
involve inherent risks and uncertainties. A number of important factors could
cause actual results to differ materially from those contained in any
forward-looking statement. Sinovac does not undertake any obligation to update
any forward-looking statement, except as required under applicable law.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.
The Ruth Group
The Ruth Group
SOURCE Sinovac Biotech Ltd.
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