BEIJING, May 5 Sinovac Biotech Ltd. (Nasdaq: SVA), aleading China-based vaccine manufacturer, announced today that its 30%-ownedjoint venture, Sinovac Dalian, has submitted an application to China's StateFood and Drug Administration (SFDA) to commence human clinical trials for itsmumps vaccine. The proprietary mumps vaccine developed by Sinovac Dalianrepresents not only the first live attenuated vaccine for which Sinovac hasfiled a clinical trial application, but also the first candidate from thejoint venture's pipeline for which a clinical trial application has beensubmitted to and accepted by the SFDA since the formation of the joint venturein January 2010.
Currently, the R&D process for the rubella vaccine is progressing onschedule and the development plan for measles vaccine is underway.Post-approval of a mumps vaccine, the Company plans to commercialize acombination measles, mumps and rubella (MMR) vaccine that will be eligible forthe government purchasing program. In February 2008, the Chinese governmentincluded the MMR vaccine in its national expanded program for immunization.Based on the number of children within the target age group of this program,the annual market demand in China for the MMR vaccine is estimated to beapproximately 30 million doses. This projected market demand exceeds the 12.5million doses of the MMR vaccine that were approved and released in China in2009.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Thissubmission to the SFDA for approval to commence clinical trials for the mumpsvaccine is a major milestone for us as it is the first live attenuated vaccinethat our company has brought to this point. In addition, the mumps vaccine isthe first candidate from Sinovac Dalian's development pipeline to be submittedfor human clinical trials. Sinovac Dalian will continue to bring strategicvalue to our company and its stakeholders as this program moves towardcommercialization given that the manufacturing facility for the mumps vaccineis already in place and we are prepared to commence manufacturing upon receiptof the production license from the SFDA. After we receive approval for theclinical trial application from the SFDA, we look forward to commencing theclinical trials for the mumps vaccine and moving towards the commercializationof a mumps vaccine as the first step and then a MMR combination vaccine in thecoming years."
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'scommercialized vaccine products include Healive(R) (hepatitis A), Bilive(R)(combined hepatitis A and B), Anflu(R) (seasonal influenza), Panflu(TM)(pandemic influenza (H5N1)), and Panflu.1(TM) (pandemic influenza A (H1N1)).Sinovac is developing vaccines for enterovirus 71, universal pandemicinfluenza, pneumococcal infection, Japanese encephalitis, and human rabies.Its wholly owned subsidiary, Tangshan Yian, is conducting field trials forindependently developed inactivated animal rabies vaccines. Its 30%-ownedjoint venture, Sinovac Dalian, focuses on the research, development,manufacturing and commercialization of vaccines, such as rabies, chickenpox,mumps and rubella vaccines for human use.
About Mumps Vaccine in China
According to the batch release data furnished by China's NationalInstitute for the Control of Pharmaceutical Biological Products (NICPBP), thetotal released quantity in 2009 for mumps related vaccines, inclusive of theMMR, MM(measles and mumps combined), single measles, single mumps and singlerubella vaccines, was 115 million doses. According to NICPBP batch lotrelease records, 12.5 million doses of MMR were approved and released in Chinain 2009, compared to 7.0 million doses in 2008.
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 are nothistorical 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 anyforward-looking statement. Sinovac does not undertake any obligation to updateany forward-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/Stephanie Carrington The Ruth Group Tel: +1-646-536-7023/7017 Email: [email protected] [email protected]
Media Janine McCargo The Ruth Group Tel: +1-646-536-7033 Email: [email protected]
SOURCE Sinovac Biotech Ltd.