Sinovac Biotech Ltd., a China-based vaccine manufacturer, announced today that its 30%-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration (SFDA) to commence human clinical trials for its mumps vaccine. The proprietary mumps vaccine developed by Sinovac Dalian represents not only the first live attenuated vaccine for which Sinovac has filed a clinical trial application, but also the first candidate from the joint venture's pipeline for which a clinical trial application has been submitted to and accepted by the SFDA since the formation of the joint venture in January 2010.
Currently, the R&D process for the rubella vaccine is progressing on schedule and the development plan for measles vaccine is underway.
Post-approval of a mumps vaccine, the Company plans to commercialize a combination measles, mumps and rubella (MMR) vaccine that will be eligible for the government purchasing program. In February 2008, the Chinese government included 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 be approximately 30 million doses. This projected market demand exceeds the 12.5 million doses of the MMR vaccine that were approved and released in China in 2009.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, "This submission to the SFDA for approval to commence clinical trials for the mumps vaccine is a major milestone for us as it is the first live attenuated vaccine that our company has brought to this point. In addition, the mumps vaccine is the first candidate from Sinovac Dalian's development pipeline to be submitted for human clinical trials. Sinovac Dalian will continue to bring strategic value to our company and its stakeholders as this program moves toward commercialization given that the manufacturing facility for the mumps vaccine is already in place and we are prepared to commence manufacturing upon receipt of the production license from the SFDA. After we receive approval for the clinical trial application from the SFDA, we look forward to commencing the clinical trials for the mumps vaccine and moving towards the commercialization of a mumps vaccine as the first step and then a MMR combination vaccine in the coming years."