Sinovac receives revised Chinese approvals for Panflu

Jun 30 2009

Sinovac Biotech Ltd. has announced that it 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.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Having received approval to administer our Panflu vaccines to individuals over the age of 60, Sinovac now has the ability to protect a much larger percentage of the Chinese population from pandemic influenza viruses. The revised approval is especially important, as the 60+ age group is often a high-risk group. We also now have the ability to supply a greater number of vaccines, as the approval to increase the Panflu packaging to 1mL. We continue to expect to complete production of the first batch of H1N1 Panflu vaccine by the end of the July. With these revised approvals, Sinovac is better positioned to deliver on its first order from the Beijing government, as well as additional government orders we may receive in the future."

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.