Full Press Release Details
SINOVAC BIOTECH 6K, PRESS RELEASE 12.06.04
SINOVAC BIOTECH LTD.
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PHASE I HUMAN CLINICAL TRIAL SHOWS ITS SARS VACCINE TO
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BE SAFE AND TO INDUCE SARS-NEUTRALIZING ANTIBODIES
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BEIJING, December 6, 2004 - Sinovac Biotech Ltd. ("Sinovac") ("the Company")
(NASD OTC-BB: SNVBF) announces that its inactivated SARS vaccine showed no
obvious side-effects and induced the production of SARS-neutralizing antibodies
- after completion of a 56-day observation period of all 36 subjects
participating in the Phase I human clinical trial.
Wei Dong Yin, President of Sinovac and head of the national SARS research of
China stated, "We have finished our first-phase clinical trial in line with
international vaccine clinical trial requirements". He added that the Phase I
trial is mainly aimed at evaluating the safety and immunogenicity of the
vaccine. The studies show that the vaccine induces antibodies that were shown to
neutralize the SARS virus in in vitro testing of subjects' blood serum.
More details will follow in a follow-up Sinovac news release within 24 hours.
SARS, a viral respiratory illness caused by a coronavirus, was first reported in
Asia in February 2003, and over the following few months, the illness spread to
more than two dozen countries in North America, South America, Europe, and Asia.
According to the World Health Organization, during the SARS outbreak of 2003, a
total of 8,098 people worldwide became sick with SARS; of these, 774 died. The
SARS global outbreak of 2003 was contained; however, it is expected that the
disease could re-emerge in an annual cycle similar to the common flu.
In a recent CNN article, representatives of world health authorities have again
warned recently that the world should prepare for a recurrence of SARS, but that
an epidemic is unlikely as China is now better prepared:
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About Sinovac Biotech Ltd.
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Sinovac Biotech Ltd. specializes in the research, development,
commercialization, and sales of human vaccines for infectious illnesses such as
hepatitis A and hepatitis B, influenza, "SARS", and avian flu. Sinovac is one of
the leading emerging biotechnology companies in China.
Sinovac has three vaccines that have completed all three phases of clinical
trials - Hepatitis A, Hepatitis A&B combined, and influenza (flu). The Hepatitis
A vaccine, Healive(TM), is currently experiencing strong sales growth in China
and applications have been filed for its sale in nine other countries to date.
Sinovac's Hepatitis A&B combined vaccine, Bilive(TM), is expected to receive
approval to commence sales in China soon and to achieve similar sales growth to
Healive(TM). The flu vaccine completed clinical trials in April 2004 and a New
Drug Application has been filed with the SFDA (Chinese FDA). Approval of
Sinovac's flu vaccine is expected in 2005 upon completion of the flu vaccine
production line. Since demand for a safe and effective flu vaccine in China
greatly outstrips supply, sales are expected to escalate rapidly. Furthermore,
since individuals are vaccinated against the flu on an annual basis, demand will
remain high every year.
Sinovac is currently the only company in the world to be conducting clinical
trials for a vaccine to prevent SARS. The Company has also started development
for a vaccine targeting avian flu.
Management invites shareholders and interested parties to email media articles,
or indeed any information that relates to Sinovac, its vaccines and the
respective viruses that each one treats, to info@sinovac.com. Articles that have
already been published will be added to a media library on the Sinovac web-site
which is currently being re-designed, and new articles that are received on an
ongoing basis will be posted regularly.
For further information please refer to the Company's filings with the SEC on
EDGAR or refer to Sinovac's website at www.sinovac.com.
If you would like to receive regular updates on Sinovac please send your email
request to info@sinovac.com.
Contact: Investor Relations at (888) 888-8312 or 1 604 684-5990 from outside of
North America or info@sinovac.com
THIS NEWS RELEASE MAY INCLUDE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF
SECTION 27A OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, AND SECTION
21E OF THE UNITED STATES SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED, WITH
RESPECT TO ACHIEVING CORPORATE OBJECTIVES, DEVELOPING ADDITIONAL PROJECT
INTERESTS, SINOVAC'S ANALYSIS OF OPPORTUNITIES IN THE ACQUISITION AND
DEVELOPMENT OF VARIOUS PROJECT INTERESTS AND CERTAIN OTHER MATTERS. THESE
STATEMENTS ARE MADE UNDER THE "SAFE HARBOR" PROVISIONS OF THE UNITED STATES
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 AND INVOLVE RISKS AND
UNCERTAINTIES WHICH COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE
IN THE FORWARD-LOOKING STATEMENTS CONTAINED HEREIN.