BEIJING, March 17, 2015
/PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading
provider of biopharmaceutical products in China, today provided updates on the Company's
pipeline vaccines.
EV71 vaccine. The Company submitted supplementary
documentation to the China Food and Drug Administration (CFDA) at
the end of January 2015, as required
following review of the new drug application (NDA) by an expert
panel in November 2014. The CFDA has
begun its review of the supplementary documentation. Sinovac
maintains regular communication with relevant departments of CFDA,
in order to be prepared for the upcoming on-site inspection, sample
testing, and production and lot release after the product is
commercialized. Once the on-site inspection and sample testing are
successfully completed, Sinovac will receive the new drug
certificate, production license and GMP license to begin commercial
production of its EV71 vaccine.
EV71 is a virus that causes hand, foot and mouth disease (HFMD)
and is the primary cause of most severe and fatal cases of hand,
foot and mouth disease (HFMD) in China. According to the Chinese CDC, there
were approximately 2.78 million reported cases of HFMD in 2014 and
508 fatal cases.
Please see the Company's 20-F filing on April 16, 2014 at www.SEC.gov for a complete
outline of the NDA process.
Other Pipeline Vaccines
Pneumococcal 23-valent polysaccharide vaccine (PPV). The
Company obtained its clinical trial license in May 2014. Sinovac is currently completing
clinical trial preparations and expects to start trials in the
first half of 2015.
Varicella vaccine. The Company is currently preparing
supplementary material for the clinical trial application,
following review by an expert panel in November 2014. The Company expects to receive its
clinical trial license in 2015. Sinovac filed the clinical trial
application with the CFDA in January
2013.
Pneumococcal 13-valent conjugate vaccine (PCV). The
Company obtained its clinical trial license in January 2015, having filed its application with
the CFDA in March 2011. PCV is targeted for children under two
years old. Sinovac will finalize its clinical trial protocols based
on Good Clinical Practice (GCP) and related technical guidelines
and initiate production and testing for vaccines to be used in
clinical trial accordingly. The Company is required to commence the
trials within three years after the license is issued.
Sabin-inactivated polio vaccine (sIPV). The clinical
trial application for the vaccine was accepted by Beijing Food and
Drug Administration in October 2014
and is under review by the CDE.
Hepatitis B vaccine and new generation of hepatitis A & B
vaccine. The Company has completed pre-clinical studies for its
proprietary hepatitis B vaccine and filed a clinical trial
application in December 2014.
Simultaneously, Sinovac is developing a new generation of its
hepatitis A & B combination vaccine based on its individual
hepatitis A and B vaccines. The new generation combination vaccine
will contain a higher dosage of the hepatitis B component,
10ug and 20ug for pediatric and adult formulations,
respectively, to enhance the vaccine's immunogenicity. And the
clinical trial application for the combined vaccine was submitted
in December 2014.
Rubella vaccine. The Company obtained the clinical trial
license in December 2014. This
vaccine is expected to be developed as a measles, mumps and rubella
(MMR) combination vaccine. The Company filed its application for
clinical trial with the CFDA in April
2011.
Mr. Yin concluded, "The continued advancement of our vaccine
pipeline is evidence of our strong R&D capabilities. With these
capabilities and commercial execution strategies, Sinovac is well
positioned to grow over the long-term. I am confident that our
pipeline will continue to progress as we work towards our mission
of providing protection against infectious diseases
in China and other emerging markets."
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
hepatitis A and B, seasonal influenza, H5N1 pandemic influenza
(avian flu), H1N1 influenza (swine flu), mumps and canine rabies.
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. Sinovac
has filed a new drug application with the China Food & Drug
Administration for its proprietary enterovirus 71 vaccine, having
been proven effective in preventing hand, foot and mouth disease in
infants and children during its Phase III clinical trial. 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 Mexico,
Mongolia, Nepal, and the
Philippines, and was recently granted a license to
commercialize its hepatitis A vaccine in Chile. For more information, please visit the
Company's website at www.sinovac.com.
Contact
Sinovac Biotech Ltd.
Helen Yang / Chris Lee
Tel: +86-10-8279-9659 / 9696
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 Ltd.