Sinovac Files Registration Documents for Euvax-B(TM) with SFDA Loan Repayment Received from One Former Director
Thursday February 8, 8:00 am ET
BEIJING, Feb. 8 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (Amex: SVA
), a leading provider of biopharmaceutical products in China, today announced it has filed registration documents with the China State Food and Drug Administration for LG Life Sciences (LGLS) hepatitis B vaccine, Euvax-B(TM). Sinovac is the exclusive distributor for Euvax-B pursuant to a distribution agreement with LGLS signed in February 2006.
Mr. Changjun Fu, Vice President in charge of sales and marketing, said, "The filing of the registration statement is a key step in our ongoing efforts to obtain regulatory approval to sell Euvax-B in China. We look forward to bringing this hepatitis B vaccine to market through Sinovac's established distribution network."
As previously disclosed, Sinovac issued loan repayment letter in June 2006 to two of its former directors, Lily Wang and Heping Wang, in an effort to take immediate remedial steps to address any potential violation of Section 402 of the Sarbanes-Oxley Act. The Company has recently received full repayment in the amount of US$ 562,515.31 from Lily Wang, a former director and CFO until March 22, 2006, for the outstanding balance of a loan owed to the Company arising from her earlier acquisition of Tangshan Yian's equity interest in Sinovac Beijing. The loan in aggregate amount of RMB 10.8 million owed to the Company by Heping Wang for his assuming Tangshan Yian's loan obligations remains outstanding. The Company is working with Mr. Wang in resolving this remaining issue.
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 vaccines include Healive(TM) (hepatitis A), Bilive(TM) (combined hepatitis A and B) and Anflu(TM) (influenza). Sinovac is currently developing human vaccines against the H5N1 strain of pandemic influenza, Japanese encephalitis and SARS. Additional information about Sinovac is available on its website, http://www.sinovac.com
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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 x871
Investors / Media:
Stephanie Carrington / Janine McCargo
The Ruth Group
Tel: +1-646-536-7017 / 7033
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, and mumps.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.
For more information, please see the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.