BEIJING, Aug. 31 Sinovac Biotech Ltd. (NYSE Amex:SVA), a leading provider of biopharmaceutical products in China, announcedtoday that Sinovac's H1N1 vaccine has passed the experts evaluation organizedby State Food and Drug Administration (SFDA). The vaccine is expected toobtain the production license within this week.
On August 30 and 31, 2009, State Food and Drug Administration (SFDA)organized and held an experts evaluation conference focused on A/H1N1 vaccinesto evaluate Sinovac's H1N1 vaccine, which has recently completed a clinicaltrial. Top-line results from the trial demonstrated Sinovac's H1N1 vaccine tohave a good safety profile and immunogenicity factors that reach the EUcriterion after a single shot. No severe adverse events were reported afterinoculation. Based on the results of the evaluation, the experts unanimouslyagreed that Sinovac's H1N1 vaccine is applicable to all people from 3 to 60years old and the vaccination schedule is single shot. The result of theexperts evaluation conference will be submitted to SFDA on September 1st,which will be the primary opinion for SFDA to issue the production license.
Sinovac submitted the H1N1 split influenza vaccine without adjuvant forregistration approval, which is applicable to all people from 3 to 60 yearsold. The dosage is 15ug/0.5ml/dose. Only one shot is needed for inoculation.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac commented, "We arevery excited to see that our H1N1 vaccine has passed the experts evaluationconference organized by SFDA. The evaluation result will be the importantopinion for SFDA to issue the production license. We expect to obtain theproduction license within one week. With this approval, we can continue tofulfill our mission to provide top-quality vaccines to prevent and control thespreading of H1N1 virus not only in China, but worldwide."
Sinovac Biotech Ltd. is a China-based biopharmaceutical company thatfocuses on the research, development, manufacture and commercialization ofvaccines that protect against human infectious diseases. Sinovac's vaccineproducts include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A andB), and Anflu(R) (influenza). Panflu(TM), Sinovac's pandemic influenzavaccine (H5N1), has already been approved for government stockpiling. Sinovacis developing vaccines for enterovirus 71, universal pandemic influenza,Japanese encephalitis vaccine, and human rabies vaccine. Its wholly ownedsubsidiary, Tangshan Yian, is conducting field trials for independentlydeveloped inactivated animal rabies vaccines.
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SOURCE Sinovac Biotech Ltd.