Sinovac's EV71 Vaccine Phase III Clinical Trial Results Published in New England Journal of Medicine

   Sinovac's EV71 Vaccine Phase III Clinical Trial Results Published in New
                         England Journal of Medicine

Study shows vaccine provides protection against EV71-associated hand, foot and
mouth disease in infants and young children

PR Newswire

BEIJING, Feb. 26, 2014

BEIJING, Feb. 26, 2014 /PRNewswire/ --Sinovac Biotech Ltd. (Nasdaq: SVA), a
leading provider of biopharmaceutical products in China, announced today that
Phase III clinical trial results for its proprietary Enterovirus 71 ("EV71")
vaccine have been published online in the February 27^th issue of The New
England Journal of Medicine ("NEJM"). The clinical results showed the efficacy
of the vaccine against EV71-associated hand, foot and mouth disease ("HFMD"),
or herpangina, was 94.8% among infants and young children and an anti-EV71
neutralizing antibody titer of 1:16 was associated with protection against
EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's
vaccine also demonstrated a 100% efficacy rate against EV71-associated
hospitalization and against HFMD with neurologic complications, the main cause
of fatalities.

The article, entitled "Efficacy, Safety, and Immunogenicity of an Enterovirus
71 Vaccine in China," chronicles the results of the Phase III clinical trial
on 10,077 healthy infants and young children in China (6 to 35 months of age)
with a randomized, double-blind, placebo-controlled, multicenter trial method.
The subjects were randomly assigned in a 1:1 ratio to receive two
intramuscular doses of either Sinovac's EV71 vaccine or placebo, 28 days
apart. The surveillance period was 12 months. The primary endpoint was the
occurrence of EV71-associated HFMD, or herpangina. The results showed the
vaccine can provide protection against EV71 associated HFMD in infants and
children.

According to the statistics from National Health and Family Planning
Commission of China from 2008 to 2013, more than 9 million total cases of HFMD
were reported, resulting in around 2,700 reported fatalities in China.
According to an epidemiological study for the period of 2008 to 2012, around
80% of the severe cases and over 90% of fatal cases were caused by the
enterovirus 71 (or EV71 ) infection.

Fengcai Zhu, M.D., Director of Jiangsu Centers for Disease Control and
Prevention, co-principal investigator and lead author, said, "This study
showed that the EV71 vaccine provides protection to the infants and young
children against EV71-associated HFMD and the vaccine candidate has good
safety and immunogenicity profile. HFMD has been an increasingly important
public health issue among the young children in Asia-Pacific region, including
China, and caused a significant social burden. The successful development of
the EV71 vaccine is an exciting achievement by Sinovac, as it will provide an
effective tool to protect infants and young children against EV71 associated
HFMD, especially at the level of severe cases and potential fatalities."

Mr. Weidong Yin, Chairman, President and CEO commented, "The peer-reviewed
publication in NEJM of our Phase III clinical trial results shows that our
scientific contribution is acknowledged by the academia. The follow-up
research is still ongoing. As there is no commercialized vaccine and no EV71
specific treatment available, there are increasing unmet medical needs. We are
pleased to see that our vaccine is able to provide protection to infants and
children against the EV71-associated HMFD. Sinovac is well prepared for the
commercialization of this much needed vaccine. Once the regulatory approval is
granted, we will be able to contribute to the overall control and prevention
of this devastating disease."

About EV71 and HFMD

Enterovirus 71, or EV71, causes Hand, Foot, and Mouth Disease (or HFMD). More
than 90% of the reported cases occur in children under five years old. HFMD is
a common and usually mild childhood disease. However, there has been an
increase in severe HFMD cases reported associated with neurological symptoms
caused by EV71. A growing number of outbreaks of EV71 HFMD have been reported
since 1997 across the Asia-Pacific region, including mainland China, Hong
Kong, Singapore, South Korea, and Taiwan. 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. No
specific treatment for this enterovirus infection and no vaccine are currently
available.

In China, HFMD has become a very serious problem, especially in children,
given that no vaccine and specific treatment is currently available to protect
against this disease. In March 2008, an EV71 outbreak in Fuyang City of
China's Anhui Province caused 23 fatalities, and attracted significant
attention from the government and medical communities. In May 2008, the
Chinese Ministry of Health identified EV71 as a Class C infectious disease
according to prevention and control regulations. EV71 outbreaks have increased
over the last five years, with more than 1 million cases identified and 500 to
900 reported fatalities each year. According to the statistics from National
Health and Family Planning Commission of China from 2008 to 2013, more than 9
million cases of HFMD have been reported, resulting in around 2,700
fatalities.

About Sinovac's EV71 Vaccine

Sinovac Biotech Ltd. commenced research and development for its independently
developed EV71 vaccine in 2008. In December of 2009, Sinovac completed
pre-clinical research and filed a clinical trial application to China Food and
Drug Administration (CFDA) and in December 2010, received CFDA's approval to
assess safety and immunogenicity in Phase I and II clinical trials, and to
conduct an efficacy study in a Phase III clinical trial. In 2011, Sinovac
conducted and completed Phase I and II clinical trials. The results
demonstrated that Sinovac's EV71 vaccine has a good safety and immunogenicity
profile, which was the basis for the recently concluded Phase III clinical
trial for efficacy in the beginning of 2012. The phase I clinical result was
published by the peer-reviewed journal Vaccine in March of 2012. The phase II
clinical results were published by "The Journal of Infectious Diseases" in
2013. And also in 2013, the results on immunogenicity, safety and lot
consistency study in phase III clinical trial were published in "Clinical and
Vaccine Immunology."

About Sinovac

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.
Tel: +86-10-8279-9659/9696
Fax: +86-10-6296-6910
Email: ir@sinovac.com 

Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com 

Media:
Aaron Estrada
The Ruth Group
Tel: +1-646-536-7028
Email: aestrada@theruthgroup.com 

SOURCE Sinovac Biotech Ltd.

Website: http://www.sinovac.com
 
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