Full Press Release Details
Provides Updates on Pipeline Vaccines
March 17, 2015 /PRNewswire/ -- Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical
products in China, today provided updates on the Company's pipeline vaccines.
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.
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.
see the Company's 20-F filing on April 16, 2014 at www.SEC.gov for
a complete outline of the NDA process.
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.
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.
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
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.
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, 10ugand 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
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
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."
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.
Tel: +86-10-8279-9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com
Email: william.zima@icrinc.com