SUNDAY, JUNE 17, 2018

Sinovac submits clinical trial application for mumps vaccine

China-based vaccine manufacturer Biotech Ltd. has submitted an application to the China State Food and Drug Administration to begin human clinical trials for a mumps vaccine, Medical News Today reports.

The mumps vaccine, developed by Biotech Limited subsidiary Sinovac Dalian, marks the first live vaccine the company has filed a clinical trial application for.

“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," Weidong Yin, Sinovac's president and CEO, told Medical News Today. "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."

The total released quantity in 2009 for mumps related vaccines was 115 million doses, according to the batch release data furnished by China's National Institute for the Control of Pharmaceutical Biological Products. According to the  NICPBP data, 12.5 million doses of MMR were approved and released in China in 2009, compared to 7.0 million doses in 2008.