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 September 2012
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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:
Form 20-F x 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.
SINOVAC BIOTECH LTD.
By: /s/ Weidong Yin
Name: Weidong Yin
Title: Chairman and Chief Executive Officer
Date: September 26, 2012
Exhibit Index
Exhibit 99.1 – Press Release
Exhibit 99.2 – Press Release
Exhibit 99.3 – Press Release
Exhibit 99.1
Sinovac Receives Beijing CDC Tender Award to Supply Seasonal Flu Vaccine Anflu(R) to Beijing Citizens
Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, announced today that it has been selected by the Beijing Centers for Disease Control and Prevention (Beijing CDC) to supply seasonal influenza vaccine to the citizens of Beijing.
Dr. Weidong Yin, Chairman, President and CEO of Sinovac, stated, "Sinovac was chosen once again as one of the four manufacturers by the Beijing CDC to supply doses for the seasonal flu vaccination campaign. As part of the bidding process, the Beijing CDC evaluated potential suppliers and assigned scores for different factors, including product quality, service and price. Based on the comprehensive scores, Sinovac was selected for the fifth time in recent years to participate in this vaccine campaign targeting the geriatric publication and school age children in Beijing. "
The Beijing CDC plans to order up to a total of 1.8 million doses of seasonal flu vaccine in 2012 for the vaccination campaign from four vaccine manufacturers. The total quantity of vaccine doses to be supplied will depend on the actual demand in Beijing. Delivery is expected to commence during the third quarter of 2012. In 2011, total about 360,000 doses of Anflu were inoculated to the target population for the vaccination campaign in Beijing. According to public data as of November 22, 2011, over 1.3 million doses of seasonal flu vaccines were inoculated in Beijing, inclusive of the target population covered by the free vaccination campaign.
Starting in 2007, to prevent and control the seasonal flu, the Beijing CDC began purchasing the seasonal flu vaccines to immunize the elderly population over 60 and the elementary and secondary school students in Beijing.
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 including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu), as well as animal rabies vaccine for canines. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, mumps and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.
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, 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.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871/9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com
Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com
Media:
Victoria Aguiar
The Ruth Group
Tel: +1-646-536-7013
Email: vaguiar@theruthgroup.com
Exhibit 99.2
Sinovac Biotech Receives GMP Certification for Mumps Vaccine Production Facility
Sinovac Biotech Ltd. (SVA), a leading China-based vaccine manufacturer, announced today that it has received GMP certification from the China State Food and Drug Administration (SFDA) for the Company's dedicated mumps vaccine production plant at its Sinovac Dalian facility. The SFDA issued a public announcement on September 12, 2012, stating that the Good Manufacturing Practices (GMP) certification was issued to Sinovac with the certificate number CN20120080.
The SFDA issued a public notification in July 2012 stating that Sinovac Dalian's mumps vaccine production plant is in compliance with the new GMP guidelines (2010 version) following the site inspection and documentation review. The Company obtained the production license from the SFDA for its mumps vaccine in December 2011. Sinovac continues to anticipate that it will be in a position to commence commercial production of the mumps vaccine in the third quarter 2012 and is on track to launch the mumps vaccine in China following the batch release process.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Obtaining GMP certification for the mumps vaccine production facility is a significant milestone as we advance our development pipeline and expand our portfolio of commercialized vaccines. We are poised to leverage our established sales and marketing team and distribution network that covers over 1,000 clients at Centers of Disease Control and Points of Vaccination across China. The commercialization of mumps vaccine is a testament to our capabilities to develop additional live attenuated vaccines. Commercial production of the mumps vaccine will commence immediately and we anticipate launching the vaccine either later this year or early next year following the batch release process."
Approximately 13 million doses of mumps vaccine were released by National Institutes for Food and Drug Control (NIFDC) in 2011, and a total 3.15 million doses of mumps vaccines have been released for the eight months through August 2012. Currently, only two companies are providing the mumps vaccine in the China private market, both of which are domestic manufacturers. The launch of the mumps vaccine is Sinovac's first step towards developing a combination MMR (measles, mumps and rubella) vaccine, which is now included in the expanded program of immunization (EPI) and garnered increasing market demand in recent years.
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 including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu), as well as animal rabies vaccine for canines. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, mumps and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.
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, 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.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871/9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com
Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com
Media:
Victoria Aguiar
The Ruth Group
Tel: +1-646-536-7013
Email: vaguiar@theruthgroup.com
Exhibit 99.3
Sinovac Awarded Tenders in Beijing and Shanghai to Supply Inactivated Hepatitis A Vaccine Healive® Under Expanded Immunization Program
BEIJING, Sept. 25, 2012 -- Sinovac Biotech Ltd. (SVA), a leading China-based vaccine manufacturer, announced today that it has been selected by the Beijing Health Bureau and the Shanghai Centers for Disease Control and Prevention (Shanghai CDC) to supply the Company's inactivated hepatitis A vaccine, Healive, to the Expanded Program of Immunization (EPI) for each city. The tenders awarded to Sinovac in Beijing and Shanghai are valued at approximately 20 million RMB and 13 million RMB, respectively. The vaccine purchased by the Beijing Health Bureau will be administered over a two year period to the pediatric population across the city. The vaccine purchased by the Shanghai CDC is for the 2012 pediatric population inoculation program.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "We are pleased to have been selected as the sole supplier of the inactivated hepatitis A vaccine in prefilled syringe in both Beijing and Shanghai. Given its superior safety profile and proven efficacy, Healive will be provided to newborns under the Beijing and Shanghai immunization programs using our easy-to-use pre-filled syringes. We will continue to collaborate with government agencies to provide top-quality vaccines to prevent diseases in China and beyond."
Healive is the first inactivated hepatitis A vaccine developed, produced and marketed by a China-based manufacturer. Healive was launched by Sinovac in 2002 in China and is currently available in adult and pediatric dosage forms. In February 2008, the Chinese government included hepatitis A vaccine in its national immunization program.
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 including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu), as well as animal rabies vaccine for canines. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program. Sinovac is developing a number of new pipeline vaccines including vaccines for enterovirus 71 (against hand, foot and mouth disease), pneumococcal conjugate, pneumococcal polysaccharides, mumps and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.
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, 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.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel: +86-10-8279-9871/9659
Fax: +86-10-6296-6910
Email: ir@sinovac.com
Investors:
Stephanie Carrington
The Ruth Group
Tel: +1-646-536-7017
Email: scarrington@theruthgroup.com
Media:
Victoria Aguiar
The Ruth Group
Tel: +1-646-536-7013
Email: vaguiar@theruthgroup.com