Sinovac Receives Revised Approvals for Panflu
June 29 2009 - 7:00AM
PR Newswire (US)
Extension of Eligible Age Group Enables Sinovac to Cover Larger
Part of Population BEIJING, June 29 /PRNewswire-Asia/ -- Sinovac
Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of
vaccines in China, announced today that it has received a revised
Drug Supplementary Application Approval for Panflu(TM), Sinovac's
pandemic influenza vaccine from the China State Food and Drug
Administration (SFDA), based on the Phase IIb clinical trial, Under
the revised approval, the age group eligible for use of the whole
viron inactivated pandemic influenza vaccine was expanded to 18
years old and over, whereas it was previously 18 to 60 years of
age, enabling Sinovac to reach a much broader percentage of the
population. Sinovac also received a Supplementary Application
Approval to change the existing packaging of 0.5mL per vial of
Panflu to 1mL per vial, which will enable Sinovac to double its
filling and packaging capacity. Mr. Weidong Yin, Chairman,
President and CEO of Sinovac, commented, "Having received approval
to administer our Panflu vaccines to individuals over the age of
60, Sinovac now has the ability to protect a much larger percentage
of the Chinese population from pandemic influenza viruses. The
revised approval is especially important, as the 60+ age group is
often a high-risk group. We also now have the ability to supply a
greater number of vaccines, as the approval to increase the Panflu
packaging to 1mL. We continue to expect to complete production of
the first batch of H1N1 Panflu vaccine by the end of the July. With
these revised approvals, Sinovac is better positioned to deliver on
its first order from the Beijing government, as well as additional
government orders we may receive in the future." Sinovac is
currently focused on production of a vaccine against the new
pandemic influenza strain, H1N1. This vaccine will be sold under
the Panflu brand, which has in the past also referred to Sinovac's
vaccine against the pandemic influenza strain, H5N1. Sinovac
expects to complete production of its first batch of the H1N1
Panflu vaccine by the end of July 2009. 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 vaccine, and human rabies
vaccine. 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: Helen G. Yang Sinovac Biotech Ltd.
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: +1-656-536-7033
Email: DATASOURCE: Sinovac Biotech Ltd. CONTACT: Helen G. Yang,
Sinovac Biotech Ltd. at +86-10-8289-0088 x9871, fax:
+86-10-6296-6910 or ; Investors: Amy Glynn & Sara Pellegrino,
The Ruth Group at +1-646-536-7023 & 7002 or & ; Media:
Janine McCargo, The Ruth Group at +1-656-536-7033 or
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