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Sinovac Receives Certificate Of Approval To Distribute Panflu (H5N1) Vaccine In Hong Kong
Oct 14, 09 FDA ApprovalsSinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China, announced that its wholly-owned subsidiary, Sinovac Biotech (Hong Kong) Ltd, has received the Certificate of Approval to distribute Panflu(TM) (H5N1), its H5N1 (bird flu) pandemic influenza vaccine, in Hong Kong. The certificate is valid through September 13, 2014 and thereafter will be renewable for periods of five years at a time, subject to payment of the registration fee.
Sinovac Biotech (Hong Kong) Ltd, was established in October 2008 to focus on registering and distributing Sinovac’s vaccines in Hong Kong and seeking vaccine R&D opportunities in Hong Kong. In the coming months, the Company plans to submit applications in Hong Kong for approval for its Panflu.1 (H1N1) and Anflu vaccines.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “We are pleased to receive approval to market Panflu in Hong Kong, as it represents an opportunity to significantly expand our market reach. In working closely with Hong Kong officials on regulatory approval for Panflu, we have gained knowledge about the regulatory process there and plan to submit applications in the near future for additional vaccines, specifically Panflu.1 for swine flu and Anflu. And at the same time, Hong Kong officials have gained an overall understanding of the quality of Sinovac’s product. The approval in Hong Kong for Panflu is a significant step in our mission to distribute our affordable, high-quality and safe vaccines on a global basis.”
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, and human rabies. 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.
Source: Sinovac Biotech Ltd
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