BEIJING, Sept. 25, 2017 /PRNewswire/ -- Sinovac Biotech
Ltd. (SVA), a leading provider of vaccines in China, announced today preliminary top-line
data from its Phase III clinical trial assessing the efficacy,
immunogenicity and safety of the Company's proprietary Varicella
vaccine against Chickenpox.
The primary objective of the study was to evaluate the efficacy
of the Varicella vaccine in the prevention of Chickenpox caused by
Varicella-Zoster Virus (VZV). The preliminary Phase III data
showed that Sinovac's Varicella vaccine was 87.1% (95% CI: 69.7%,
94.5%) efficacious against Chickenpox caused by VZV.
The double-blinded, randomized, placebo controlled Phase III
clinical trial was conducted at two sites across China's Henan
province. Approximately 6,000 healthy children from 1 to 12
years old completed the one dose vaccination schedule in the August
of 2016, prior to the Chickenpox epidemic season in China, followed by an active monitoring
period.
In parallel, Sinovac conducted another clinical study that was
comprised of 1,197 volunteers and designed to evaluate the
consistency of three consecutive lots of Varicella vaccine
manufactured by the Company. The trial was conducted in children
from 1 to 3 years old. After receiving the vaccine, the ratios of
antibody GMTs on the 30th day of any two groups were calculated and
the 95% confidence intervals of the ratios were all between 0.67
and 1.5, which indicates that the immunogenicity of the three
vaccine lots is consistent. The study results showed consistent
immune response for all three lots and a good safety
profile. With immunogenicconsistency across the three
consecutive lots, the results showed that Sinovac's vaccine
production process and quality are stable. The production facility
of Varicella vaccine has also reached commercial scale.
Mr. Weidong Yin, Chairman,
President and CEO of Sinovac, commented, "We are pleased to report
an over 87% efficacy rate from the Phase III trial of our Varicella
vaccine. The conclusion of this trial means that we are on track
for commercialization by the end of 2019 and marks an important
milestone in our goal to commercialize the varicella vaccine.
Once commercialized, the Varicella vaccine will be supplied to meet
existing market demand and support our subsidiary Sinovac Dalian in
strengthening its financial position in the near future."
Sinovac obtained clinical research approval for its proprietary
Varicella vaccine candidate from the CFDA in September 2015, and completed Phase I clinical
trials in 2016. The preliminary results of the Phase I studies
confirmed that Sinovac's vaccine candidate has a good safety
profile.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that
focuses on the research, development, manufacturing and
commercialization of vaccines that protect against human infectious
diseases. Sinovac's product portfolio includes vaccines against
enterovirus 71, or EV71, hepatitis A and B, seasonal influenza,
H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu),
and mumps.In addition, an innovative vaccine developed by Sinovac
against hand foot and mouth disease caused by EV71 was
commercialized in China in 2016.
In 2009, Sinovac was the first company worldwide to receive
approval for its H1N1 influenza vaccine, which it has supplied to
the Chinese Government's vaccination campaign and stockpiling
program. The Company is also the only supplier of the H5N1 pandemic
influenza vaccine to the government stockpiling program. The
Company is currently developing a number of new products including
a Sabin-strain inactivated polio vaccine, pneumococcal
polysaccharides vaccine, pneumococcal conjugate vaccine and
varicella vaccine. Sinovac primarily sells its vaccines in
China, while also exploring growth
opportunities in international markets. The Company has exported
select vaccines to 10 countries in Asia and South
America. For more information, please visit the Company's
website at www.sinovac.com.
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 (including with respect to the filing of the2016
Annual Report, the compliance plan, the internal investigation, the
SEC enforcement action and the litigation matters discussed above),
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.
Contact
Sinovac Biotech Ltd.
Helen
Yang
Tel: +86-10-8279-9871
Fax: +86-10-6296-6910
Email: ir@sinovac.com
ICR Inc.
Bill Zima
U.S: 1-646-308-1707
Email: william.zima@icrinc.com
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SOURCE Sinovac Biotech Co., Ltd.