Sinovac Biotech (SVA) Receives Revised Approval for Panflu
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Sinovac Biotech Ltd. (NYSE Amex: SVA) has received a revised Drug Supplementary Application Approval for Panflu, Sinovac's pandemic influenza vaccine from the China State Food and Drug Administration (SFDA), based on the Phase IIb clinical trial.
Under the revised approval, the age group eligible for use of the whole viron inactivated pandemic influenza vaccine was expanded to 18 years old and over, whereas it was previously 18 to 60 years of age, enabling Sinovac to reach a much broader percentage of the population.
Sinovac also received a Supplementary Application Approval to change the existing packaging of 0.5mL per vial of Panflu to 1mL per vial, which will enable Sinovac to double its filling and packaging capacity.
Sinovac is currently focused on production of a vaccine against the new pandemic influenza strain, H1N1. This vaccine will be sold under the Panflu brand, which has in the past also referred to Sinovac's vaccine against the pandemic influenza strain, H5N1. Sinovac expects to complete production of its first batch of the H1N1 Panflu vaccine by the end of July 2009.
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. [SM]
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