UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of April 2015
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Commission File Number: 001-32371
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SINOVAC BIOTECH LTD.
No. 39 Shangdi Xi Road
Haidian District
Beijing 100085, People’s Republic
of China
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will
file annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1):________________
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(7):________________
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
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SINOVAC BIOTECH
LTD. |
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By: | |
/s/
Weidong Yin |
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Name: Weidong
Yin |
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Title: Chairman and Chief Executive Officer |
Date: April 15, 2015
Exhibit Index
Exhibit 99.1 – Press Release
Exhibit 99.2 – Press Release
Exhibit 99.3 – Press Release
Exhibit 99.1
Sinovac
Provides Updates on Pipeline Vaccines
BEIJING,
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.
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, 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
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
Exhibit
99.2
Sinovac
to Participate in China Medical and Healthcare Investment Conference
Beijing,
March 18,2014/PRNewswire/--Sinovac Biotech Ltd.(NASDAQ:SVA), a leading provider of biopharmaceutical products in China, today
announced that the Company will participate in the China Medical and Healthcare Investment Conference sponsored by T.H capital
and Dong Xing Security, to be held at China World Hotel from March 23 to March 25. The Company will present from 09:30 am
to 10:30am on March 25, and conduct one-on-one meetings during the course of the day. Any parties interested in scheduling a meeting
with the Company at this event should contact T.H capital or Dong Xing Security.
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 http://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
Exhibit
99.3
Sinovac
to Host Conference Call to Report Fourth Quarter and Full Year 2014 Unaudited Financial Results
BEIJING,
April 10, 2015 -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced
that it will release its unaudited financial results for the fourth quarter and full year, ended December 31, 2014, before market
opens on Monday, April 20, 2015. The Company will host a conference call on Monday, April 20, 2015, at 8:00 a.m. EDT (Monday,
April 20, 2015 at 8:00 p.m. China Standard Time) to review the Company's financial results and provide an update on recent corporate
developments.
To
access the conference call, please dial 1-877-407-9039 (USA) or 1-201-689-8470 (International). A replay of the call will be available
from 11 a.m. EDT on April 20, 2015 through May 4, 2015. To access the replay, please dial 1-877-870-5176 (USA) or 1-858-384-5517
(International) and reference the replay pin number 13607019.
A
live audio webcast of the call will also be available on the Investor Relations section of the Company’s website at www.sinovac.com.
A webcast replay will be available on the Company’s website for 30 days following the call.
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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