Sinovac's Animal Rabies Vaccine RabEnd Receives Production License
BEIJING, Sept. 27, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq:SVA ), a leading provider of biopharmaceutical products in China, today announced that Tangshan Yian Biological Engineering Co., Ltd., its wholly owned subsidiary, received the production license for its developed inactivated animal rabies vaccine RabEnd from China's Ministry of Agriculture (MOA).
Tangshan Yian received the production license for its inactivated animal rabies vaccine on September 22, 2011 and previously obtained the New Animal Drug Certificate and the Certificate of Good Manufacturing Practices for Animal Drugs (GMP Certificate) from the Ministry of Agriculture. According to the Requirements of Chinese Good Manufacturing Practices for Animal Drugs, the production facility for animal vaccines at Tangshan Yian can be used to manufacture different inactivated animal vaccines with the similar production processes, which can yield cost savings and shorten launch schedules for subsequent products.
Dr. Weidong Yin, Chairman, President and CEO of Sinovac, remarked, "Receiving the production license for our animal rabies vaccines is a significant milestone as it represents the final step in the regulatory process before we launch this vaccine in China. Our inactivated vaccine, which is manufactured based on the local occurring rabies virus strain, provides pet owners in China with an inactivated animal rabies vaccine with improved effectiveness and competitive quality. Leveraging our ten years of human vaccine development, production and commercialization expertise, we are replicating our quality control systems and quality standards in animal vaccines. We have established a dedicated sales force and are teaming up with distributors to make this first China developed and manufactured inactivated animal rabies vaccine available to pet owners through the animal CDC's and veterinary hospitals."
About Animal Rabies
Rabies is a zoonotic disease (a disease that is transmitted to humans from animals) that is caused by a virus. The disease infects domestic and wild animals, and is spread to people through close contact with infected saliva via bites or scratches. Animal vaccination is the most effective strategy for reducing the incidence of rabies in humans by lowering human contact with rabid animals. On January 18, 2008, China's Ministry of Agriculture and Ministry of Health approved compulsory vaccination for dogs. Based on the estimation of the industry expert, there are about 80 million to 200 million dogs in China, which represents the potential of the market.
Rabies in China
China is one of the countries most threatened by rabies. Based on available data, approximately 2400 fatal human cases of rabies are reported each year China. Rabies is a vaccine-preventable disease and spending in China on human immunization has increased in recent years. According to the WHO, dogs cause 99% of human rabies deaths and the infection source can be controlled. The most cost effective strategy for preventing human rabies is to eliminate canine rabies through vaccination.
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 including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, PANFLU.1, and has received orders from the Chinese Central Government pursuit to the government stockpiling program. The Company is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella. Its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines, and has launched its developed inactivated rabies vaccine in China.
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.
Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Stephanie Carrington/Amy Glynn
The Ruth Group
The Ruth Group
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied 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 continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.