Sinovac Biotech Ltd. (Amex:
SVA) announced today the preliminary results of its proprietary Inactivated
Pandemic Influenza Vaccine (Human-used Avian Flu Vaccine) (Panflu(TM)) in
Phase I Clinical trials. The project of R&D on Avian Flu Vaccine for human
is sponsored and supported by Ministry of Science and Technology, and is
co- developed by the Chinese Centers for Disease Control and Prevention
(CDC) and Sinovac.
The preliminary results showed good immunogenicity, with a
sero-positive rate of 78.3%, which exceeds the criteria for assessment of
vaccines established by Committee for Proprietary Medicinal Products of the
European Union.
Sinovac CEO and Chairman of the BOD, Mr. Yin Weidong commented, "This
is another success for China's biotechnology industry and an encouraging
event for us at Sinovac. Our R&D programs have many proven successes and
are the core of our business plan. It builds our organic product pipeline,
enhances our marketing and sales programs, and creates synergy with our
strategic partners."
Conduct of Phase I Clinical Trials
The purpose of Phase I was to provide an evaluation of vaccine's safety
and immunogenicity and a reference for determining the vaccine dosage for
Phase II Clinical Trial. The Trial was conducted at the Beijing Sino-Japan
Friendship Hospital in Beijing China, using a double-blind, randomized
method of testing. Double-blind studies are designed to eliminate
subjective bias on the part of both the experimental subjects and
researchers. In a double-blind experiment, neither the subjects nor the
researchers know who belongs to the control group or the experimental
group.
For this clinical trial, 120 volunteers were divided into 4 groups of
30 persons each, of which 24 of were inoculated with the pandemic influenza
vaccine and the other 6 with a placebo. Vaccine safety was documented
through Blood Routing Tests, Blood Biochemistry Tests, Urine Routing Tests,
and systemic observation of localized events. The preliminary result shows
that Sinovac's vaccine is safe for humans; no serious adverse events
occurred to any volunteers.
Next Step
Once the Phase I clinical trial is officially completed, Sinovac will
start the application process with SFDA to approve commencement for the
Phase II clinical trial. The Company will submit its summary report of
Phase I Clinical trial, plan and protocol for Phase II Clinical trial and
other relevant documents.
About Panflu(TM)
Sinovac's Panflu(TM) is a, inactivated whole virus vaccine with
adjuvant. Four antigen dosages levels were tested in the Phase I clinical
trial and all of them induced an immune response in the volunteers. The
vaccine with 10ug antigen content demonstrated the best immunogenicity,
with a sero-positive rate of 78.3%, which exceeds the criteria for
assessment of vaccines established by Committee for Proprietary Medicinal
Products of the European Union.
International Cooperation
The National Institute for Biological Standards and Control (NIBSC)
provided Sinovac with a reassortant H5N1 virus strain to be used in the
vaccine R&D process.
About Pandemic Flu
Signs of a possible pandemic flu have emerged in Southeast Asia, as
lethal infections in poultry and humans, and infections of the H5N1
influenza virus strain continue to be reported. While there is no confirmed
evidence of human-to-human transmission, there have been suspected cases
identified in Indonesia in May 2005. It is feared that if the H5N1
influenza virus undergoes either a genetic alteration or recombination with
a human influenza virus, a new subtype could emerge which could be both
highly contagious and highly lethal in humans. Such a subtype could
potentially cause a global influenza pandemic.
Most health officials estimate a flu pandemic could last a year or
more, and millions of lives could be at risk. It is believed that one of
the most effective countermeasures against pandemic flu is to manufacture
mass quantities of vaccines as quickly as possible.
About Sinovac
Sinovac Biotech Ltd. is a Chinese biopharmaceutical company, focused on
research, development and commercialization of vaccines designed to combat
human infectious diseases. Sinovac's vaccines include Healive(TM)
(hepatitis A), Bilive(TM) (hepatitis B) and Anflu(TM) (influenza). Sinovac
has vaccines in clinical trials to combat avian influenza (bird flu) and
SARS.
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.
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