Sinovac Submits Clinical Trial Application for Mumps Vaccine to SFDA
- First Live Attenuated Vaccine to be Submitted by Sinovac to SFDA for Clinical Trials -
- First Vaccine from Sinovac Dalian's Development Pipeline Accepted by SFDA Following Joint Venture's Formation in January 2010 -
BEIJING, May 5 /PRNewswire-Asia-FirstCall/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading 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."
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's commercialized 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 pandemic influenza, pneumococcal infection, Japanese encephalitis, and human rabies. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines. Its 30%-owned joint 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 National Institute for the Control of Pharmaceutical Biological Products (NICPBP), the total released quantity in 2009 for mumps related vaccines, inclusive of the MMR, MM(measles and mumps combined), single measles, single mumps and single rubella vaccines, was 115 million doses. According to NICPBP batch lot release records, 12.5 million doses of MMR were approved and released in China in 2009, compared to 7.0 million doses in 2008.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified 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 in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any 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
Amy Glynn/Stephanie Carrington
The Ruth Group
The Ruth Group
SOURCE Sinovac Biotech Ltd.
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the research, development, manufacturing, and commercialization of vaccines that protect against human infectious diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis.
SINOVAC's COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The Healive®, a hepatitis A vaccine manufactured by the Company, passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine, that was commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) was prequalified by WHO.
SINOVAC was the first company that granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied to the Chinese Government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC has been continually dedicating itself to new vaccine research and development, with more combination vaccine products in the pipeline, and constantly exploring opportunities in the international market. SINOVAC looks forward to conducting more extensive and in-depth trade and cooperation with more countries, enterprises, and professional institutions.
For more information, please see the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.