-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MRZYUEo7yRYhUT7Pya3VaDaguS8CpGX+RBX8OPiOknXkLMsPyBWIKIt8+FzASf4k A3hKWqoKbzw1r0nVJUlSAQ== 0001127855-09-000396.txt : 20090928 0001127855-09-000396.hdr.sgml : 20090928 20090928105554 ACCESSION NUMBER: 0001127855-09-000396 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090831 FILED AS OF DATE: 20090928 DATE AS OF CHANGE: 20090928 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SINOVAC BIOTECH LTD CENTRAL INDEX KEY: 0001084201 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: B9 FISCAL YEAR END: 0430 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32371 FILM NUMBER: 091089396 BUSINESS ADDRESS: STREET 1: 39 SHANGDI XI ROAD STREET 2: HAIDIAN DISTRICT CITY: BEIJING STATE: F4 ZIP: 100085 BUSINESS PHONE: 86-10-82890088 MAIL ADDRESS: STREET 1: 39 SHANGDI XI ROAD STREET 2: HAIDIAN DISTRICT CITY: BEIJING STATE: F4 ZIP: 100085 FORMER COMPANY: FORMER CONFORMED NAME: NET FORCE SYSTEMS INC DATE OF NAME CHANGE: 19991110 6-K 1 sinovac6k083109.htm SINOVAC BIOTECH 6K, 08.31.09 sinovac6k083109.htm


FORM 6-K

SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549

REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE
SECURITIES EXCHANGE ACT OF 1934

For the month of August, 2009
__________

Commission File Number: 001-32371
__________

SINOVAC BIOTECH LTD.

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 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):________________

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes _______        No        X      

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):

82-        N/A      




 
 
 

SINOVAC BIOTECH LTD.

Form 6-K

TABLE OF CONTENTS

 
Page
   
Signature
3
Exhibit 99.1 – Press Release
4


 
 
 
 
 
 
 
 

 



 
 
 
 
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:     Chief Executive Officer, President  
       
       
Date:  August 28, 2009      
 
                         
                         
 
 
 
 

 

 


 
 
 
 
 EX-99.1 2 sinovacexh99_1.htm SINOVAC BIOTECH 6K, PRESS RELEASE 08.31.09 sinovacexh99_1.htm
 
Exhibit 99.1
Sinovac's H1N1 Vaccine Passes Experts Evaluation Organized by SFDA
 
BEIJING, Aug. 31 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading provider of biopharmaceutical products in China, announced today that Sinovac's H1N1 vaccine has passed the experts evaluation organized by State Food and Drug Administration (SFDA). The vaccine is expected to obtain the production license within this week.
 
On August 30 and 31, 2009, State Food and Drug Administration (SFDA) organized and held an experts evaluation conference focused on A/H1N1 vaccines to evaluate Sinovac's H1N1 vaccine, which has recently completed a clinical trial. Top-line results from the trial demonstrated Sinovac's H1N1 vaccine to have a good safety profile and immunogenicity factors that reach the EU criterion after a single shot. No severe adverse events were reported after inoculation. Based on the results of the evaluation, the experts unanimously agreed that Sinovac's H1N1 vaccine is applicable to all people from 3 to 60 years old and the vaccination schedule is single shot. The result of the experts evaluation conference will be submitted to SFDA on September 1st, which will be the primary opinion for SFDA to issue the production license.
 
Sinovac submitted the H1N1 split influenza vaccine without adjuvant for registration approval, which is applicable to all people from 3 to 60 years old. The dosage is 15ug/0.5ml/dose. Only one shot is needed for inoculation.
 
Mr. Weidong Yin, Chairman, President and CEO of Sinovac commented, "We are very excited to see that our H1N1 vaccine has passed the experts evaluation conference organized by SFDA. The evaluation result will be the important opinion for SFDA to issue the production license. We expect to obtain the production license within one week. With this approval, we can continue to fulfill our mission to provide top-quality vaccines to prevent and control the spreading of H1N1 virus not only in China, but worldwide."
 
About Sinovac
 
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's vaccine products include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), and Anflu(R) (influenza). Panflu(TM), Sinovac's pandemic influenza vaccine (H5N1), has already been approved for government stockpiling. Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis vaccine, and human rabies vaccine. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines.
 
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.
 
 
 
 
 
For more information, please contact:
 
Helen G. Yang
Sinovac Biotech Ltd.
Tel: +86-10-8289-0088 x9871
Fax: +86-10-6296-6910
Email: info@sinovac.com
 
Investors:
Amy Glynn/Sara Pellegrino
The Ruth Group
Tel: +1-646-536-7023/7002
Email: aglynn@theruthgroup.com
           spellegrino@theruthgroup.com
 
Media:
Janine McCargo
The Ruth Group
Tel: +1-646-536-7033
Email: jmccargo@theruthgroup.com
 

 
 
 
 
 

 
 

 
 
 

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