Sinovac Biotech (Sinovac) has reported that its wholly-owned subsidiary, Sinovac Biotech (Hong Kong) has received the Certificate of Approval to distribute Panflu (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.
The company has plans to submit applications in Hong Kong for approval for its Panflu.1 (H1N1) and Anflu vaccines in the coming months.
Weidong Yin, chairman, president and CEO of Sinovac, said: “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.”