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Sinovac Files New Drug Application for EV71 Vaccine and Receives Filing Acceptance from Beijing Drug Administration

   Sinovac Files New Drug Application for EV71 Vaccine and Receives Filing
                 Acceptance from Beijing Drug Administration

PR Newswire

BEIJING, May 30, 2013

BEIJING, May 30, 2013 /PRNewswire/ --Sinovac Biotech Ltd. (NASDAQ: SVA), a
leading provider of biopharmaceutical products in China, today announced
Sinovac's new drug application (NDA) for its proprietary EV71 vaccine has been
filed and accepted by the Beijing Drug Administration. In terms of next steps
for the NDA review process in China, the Beijing Drug Administration will
conduct an on-site inspection on the circumstances of Sinovac's clinical
trials and submit its on-site inspection opinion along with the application
documentations to Centers for Drug Evaluation (CDE) of China Food and Drug
Administration (CFDA) for further review and evaluation.

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 China in 2012, 2.16 million
cases of EV71 were reported along with 560 EV71 related fatalities in 2012.

In parallel, Sinovac's dedicated EV71 vaccine manufacturing facility has been
completed and is ready for the GMP inspection by CFDA.

Dr. Weidong Yin, Chairman, President and CEO, commented, "Filing the NDA and
receiving filing acceptance from the Beijing Drug Administration is a
significant milestone as for the China regulatory process for our EV71 vaccine
candidate. Due to the severe epidemic situation among children and infants in
China, China Food and Drug Administration has been paying high attentions to
the vaccine development and aim at supplying the high-quality vaccines against
EV71 to the high-risk populations as soon as possible. As you may remember, in
late 2010, Sinovac was approved by CFDA to continuously conduct all three
phases of the human clinical trials on EV71 vaccine candidates instead of
phase by phase approval as the standard process. And according to the results
from phase III clinical trial, our vaccine candidate demonstrated
approximately 95% efficacy rate against HFMD caused by EV71 among the 10,000
healthy volunteers, ages from 6 to 35 months old in Phase III trial and has
the potential to address a significant unmet medical need facing the pediatric
population in China and surrounding countries given the high fatality rates
and rapid onset of this highly contagious disease."

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). 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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