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Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines



  Sinovac Beijing Obtains China GMP Certificate Under the New GMP Guidelines

PR Newswire

BEIJING, May 24, 2013

BEIJING, May 24, 2013 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a
leading provider of biopharmaceutical products in China, announced that
Sinovac Beijing, the main operating subsidiary company of Sinovac, obtained
the Certificate of Good Manufacturing Practices for Pharmaceutical Products
(GMP Certificate) from the China State and Food Administration (CFDA) for its
proprietary vaccines, its Haidian district bulk production plants, and its
Changping filing and packaging facility. The GMP certificate covers Sinovac
Beijing's vaccines commercialized in China and approved for stockpiling,
inclusive of hepatitis A vaccine (human diploid cell), inactivated; hepatitis
A and B combined vaccine; influenza vaccine (split virion), inactivated;
pandemic influenza vaccine (inactivated, adjuvanted); pandemic influenza
vaccine (split virion, adjuvanted); H1N1 influenza A vaccine (Split Virion,
inactivated) The GMP certificate is valid for five years starting from April
17, 2013.

New GMP standards were implemented in China by the CFDA in March 2011. These
new standards are in line with international standards. According to the
notice for the implementation of new GMP guidelines (2010 version) issued by
CFDA in February 2011, all China-based vaccine manufacturers are required to
pass the new GMP certification by the end of 2013.

In December 2012, the CFDA conducted a on-site inspection on Sinovac Beijing's
production plants in Haidian district and the new filling and packaging line
in Changping district according to the Good Manufacturing Practice for Drugs
(2010 Revision), the new GMP guidelines. The CFDA granted Sinovac the GMP
Certification in April 2013 following the March 2013 public notification
period.

Dr. Weidong YIN, Chairman, President and CEO, commented, "Sinovac Beijing's
vaccine products, its bulk production plants, and its Changping filling and
packaging facility have passed the GMP inspection and received the GMP
certificate under the new version of GMP guidelines ahead of the year end 2013
deadline. The GMP guidelines adopted in China in March 2011 are consistent
with international standards."

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:  +86-10-8279-9871/9696
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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