Sinovac Obtains Production License for H1N1 Vaccine
September 03 2009 - 8:00AM
PR Newswire (US)
BEIJING, Sept. 3 /PRNewswire-Asia/ -- Sinovac Biotech Ltd.
(NYSE:SVA), a leading provider of biopharmaceutical products in
China, announced today that the State Food and Drug Administration
(SFDA) has approved the registration application for PANFLU.1,
Sinovac's H1N1 vaccine, and has issued Sinovac a production license
for this vaccine. Following top-line results which showed that
PANFLU.1, Sinovac's H1N1 vaccine, has a good safety and
immunogenicity profile, the Company announced the findings of an
experts' evaluation conference organized by the SFDA on August 30
and 31. The experts unanimously agreed that Sinovac's H1N1 vaccine
is suitable for all people from three to 60 years old on a single
shot vaccination schedule. Mr. Weidong Yin, Chairman, President and
CEO of Sinovac, commented, "The approval of PANFLU.1, Sinovac's
H1N1 vaccine, is a significant milestone in the campaign for the
prevention and control of the H1N1 virus. With the support of the
Ministry of Health, State SFDA, Chinese Center for Disease Control
and Prevention (China CDC), Sinovac was able to successfully and
rapidly complete the clinical trials and registration process for
the H1N1 vaccine. By leveraging our expertise in R&D,
production and commercialization of human vaccines, we continue to
execute our mission to provide top-quality vaccines to eliminate
human diseases." About Sinovac Sinovac Biotech Ltd. is a
China-based biopharmaceutical company that focuses on the research,
development, manufacture and commercialization of vaccines that
protect against human infectious diseases. Sinovac's vaccine
products include Healive(R) (hepatitis A), Bilive(R) (combined
hepatitis A and B), and Anflu(R) (influenza). Panflu(TM), Sinovac's
pandemic influenza vaccine (H5N1), has already been approved for
government stockpiling. Sinovac is developing vaccines for
enterovirus 71, universal pandemic influenza, Japanese
encephalitis, and human rabies. Its wholly owned subsidiary,
Tangshan Yian, is conducting field trials for independently
developed inactivated animal rabies vaccines. 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. For more information, please
contact: Sinovac Biotech Ltd.: Helen G. Yang Tel: +86-10-8289-0088
x9871 Fax: +86-10-6296-6910 Email: Investors: Amy Glynn/Sara
Pellegrino The Ruth Group Tel: +1-646-536-7023/7002 Email: Media:
Janine McCargo The Ruth Group Tel: +1-646-536-7033 Email:
DATASOURCE: Sinovac Biotech Ltd. CONTACT: Helen G. Yang of Sinovac
Biotech Ltd., +86-10-8289-0088 x9871, Fax +86-10-6296-6910, ; or
Investors, Amy Glynn & Sara Pellegrino, +1-646-536-7023/7002, ,
, or Media, Janine McCargo, +1-656-536-7033, , all of The Ruth
Group Web site: http://www.sinovac.com/
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