BEIJING, May 14, 2015 /PRNewswire/ -- Sinovac Biotech
Ltd. (NASDAQ:SVA), a leading provider of biopharmaceutical products
in China, today announced that the
Company received site inspection notification for the commercial
production facilities of its EV71 vaccine candidate from the China
Food and Drug Administration (CFDA). This notification represents a
significant step forward for the Company in its efforts to bring
its EV71 vaccine to market.
Following the notification, Sinovac will submit its application
to schedule the site inspection, which will include production for
three consecutive trial batches of the vaccine. Samples from the
trial batches will be selected during the inspection and sent to
the National Institutes for Food and Drug Control for testing. The
Company expects this process to take four to six months.
After the trial batch testing is completed, the CFDA will
consolidate the results of the
technical review, site inspection and trial batch testing and
summarize its final opinion. The CFDA will then issue the new drug
certificate and production license.
According to new regulation, vaccine manufacturers can apply for
the GMP inspection to be conducted simultaneously with the site
inspection. Results of the GMP inspection are submitted to the
CFDA, which will then issue the GMP license once the new drug
certificate and production license are issued.
Mr. Weidong Yin, Chairman,
President and CEO of Sinovac, commented, "This is a significant
milestone in the approval process for our proprietary EV71 vaccine.
We are very pleased to be one step closer to bringing the vaccine
to market and helping to mitigate the devastating impact of this
disease in China."
EV71 is the primary cause of severe and fatal cases of hand,
foot and mouth disease (HFMD) in China. According to the data published by the
National Health and Family Planning Commission, there were over 2.8
million reported cases of HFMD in 2014, 508 of which were
fatal.
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
Tel: +86-10-8279-9659
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.