Sinovac Biotech Ltd.
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® (hepatitis A), Bilive® (combined hepatitis A and B), and Anflu® (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.
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Sinovac's bird flu vaccine wins approval in Hong Kong
Chinese vaccine developer Sinovac Biotech Ltd (Amex:SVA) announced that its wholly-owned subsidiary, Sinovac Biotech (Hong Kong) Ltd, received approval to distribute its PanFlu vaccine for the treatment of the H5N1 pandemic influenza (bird flu) in Hong Kong.
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 are designed to prevent a number of diseases including Hepatitis A and B, and various influenza.
Sinovac's Hong Kong subsidiary 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.
The approval 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.
According to Sinovac chairman Weidong Yin, this first approval in Hong Kong has provided an insight into the regulatory process. As a result Sinovac are better positioned to roll out its other vaccines into Hong Kong in the near future.
"We are pleased to receive approval to market Panflu in Hong Kong, as it represents an opportunity to significantly expand our market reach ... 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," the chairman said.
This latest news follows last month's major contract win, in which the Chinese Ministry of Industry placed an order for 3.3 million doses of the PanFlu.1 H1N1 Swine Flu vaccine.
SinoVac began producing its PanFlu branded H1N1 flu vaccine in June 2009. In August the results of the clinical trail announced that the vaccine showed good safety and immunogenicity profiles after one shot of vaccine.
Other Sinovac Biotech Ltd. news
- Sinovac Biotech receives government order for 3.3m doses of Swine Flu vaccine
2009-09-07 - Panflu vaccine gets approval for over-60s
2009-06-30
