Sinovac Biotech Ltd. (Amex:
SVA), a leading provider of biopharmaceutical products in China, today
announced that Sinovac attended the 3rd WHO meeting on evaluation of
pandemic influenza prototype vaccines in clinical trials. The meeting was
held on February 15 - 16, 2007 at the World Health Organization's
headquarters in Geneva, Switzerland.
The purpose of the forum was to review the evaluation of pandemic
vaccines in clinical trials and to make recommendations on research
activities that will contribute to the development of effective pandemic
vaccines. In attendance at this global gathering were representatives from
government regulatory agencies, pharmaceutical companies and research
professionals. Sinovac's scientist reported Phase I clinical trial results
on the forum.
Sinovac published its paper of clinical trial results, named "Safety
and immunogenicity of an inactivated adjuvanted whole-virion influenza A
(H5N1) vaccine: a phase I randomized controlled trail", an online article
for The Lancet on September 7, 2006.
In November 2006, Sinovac filed with the SFDA the application to
commence a Phase II trial for Panflu. The application is currently under
review by the SFDA and two conferences have been held with experts of SFDA.
There will be hundreds of volunteer subjects enrolled in the Phase II
clinical trial including children from 12 to 17 years old and elders over
60 years old. Sinovac expects to receive the approval to commence Phase II
clinical trial of its pandemic influenza vaccine candidate in the near
future.
About Pandemic Influenza Vaccine (H5N1)
The Pandemic influenza vaccine (H5N1) is co-developed by Chinese
Centers for Disease Control and Prevention and Sinovac Biotech Ltd. The
re-assortant H5N1 virus strain used for the vaccine development is from The
National Institute for Biological Standards and Control (NIBSC). On
November 22, 2005, State Food and Drug Administration (SFDA) approved
Sinovac commence a phase I clinical trial on its proprietary Pandemic
Influenza Vaccine (H5N1). And the trial is supported by Ministry of Science
and Technology of the People's Republic of China.
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 vaccines
include Healive(TM) (hepatitis A), Bilive(TM) (combined hepatitis A and B)
and Anflu(TM) (influenza). Sinovac is currently developing human vaccines
against the H5N1 strain of pandemic influenza, Japanese encephalitis and
SARS. Additional information about Sinovac is available on its website,
sinovac.
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.
Sinovac Biotech Ltd.
sinovac
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