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.
Safe Harbor Statement
This announcement contains forward-looking statements. These statementsare made under the "safe harbor" provisions of the U.S. Private SecuritiesLitigation Reform Act of 1995. These forward-looking statements can beidentified by words or phrases such as "will," "expects," "anticipates,""future," "intends," "plans," "believes," "estimates" and similar statements.Among other things, the business outlook and quotations from management inthis press release contain forward-looking statements. Statements that arenot historical facts, including statements about Sinovac's beliefs andexpectations, are forward-looking statements. Forward-looking statementsinvolve inherent risks and uncertainties. A number of important factors couldcause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update anyforward-looking statement, except as required under applicable law.For more information, please contact: Helen G. Yang Sinovac Biotech Ltd. Tel: +86-10-8289-0088 x9871 Fax: +86-10-6296-6910 Email: [email protected]
Investors: Amy Glynn/Sara Pellegrino The Ruth Group Tel: +1-646-536-7023/7002 Email: [email protected] [email protected]
Media: Janine McCargo The Ruth Group Tel: +1-646-536-7033 Email: [email protected]
SOURCE Sinovac Biotech Ltd.