Sinovac Receives GMP Certification for its Seasonal Influenza Vaccine, AnFlu
BEIJING--(BUSINESS WIRE)--Oct. 27, 2005--Sinovac Biotech Ltd. (AMEX:SVA - News), a leading Chinese biotechnology company in vaccine development and marketing, has announced that the State Food and Drug Administration (SFDA) issued a GMP (Good Manufacturing Practices) certificate for Sinovac's proprietary influenza flu vaccine, Anflu(TM). The GMP certificate is the final approval required to sell Anflu(TM) vaccine in China (PRC).
Sinovac Director and CEO Mr. Weidong Yin commented "Sinovac continues to implement its business strategy at an ever increasing tempo. Anflu(TM) is the third product our Company has taken from R&D to sales, and we have avian flu and Japanese Encephalitis vaccines in the pipeline."
Anflu(TM) is a modern split flu type vaccine, which typically does not produce side effects. Therefore, Anflu(TM) is much better suited to inoculating children and seniors (the two groups most at risk from influenza).
Anflu(TM) is produced in a new manufacturing facility with a full production capacity of 2 million doses of flu vaccine per year. The Company plans to build a much larger manufacturing facility of this type once it obtains financing.
Since the majority of vaccinations in China occur in September and October, Management expects Anflu(TM) will become a driver for sales in 2006.
Sinovac's successful development of a seasonal influenza vaccine is a key element in technological transfer to the research and development of pandemic influenza vaccine (H5N1). Currently, this vaccine development is in preclinical stage. Receiving GMP certification for Anflu(TM) will act as a catalyst for Sinovac's pandemic influenza vaccine (H5N1) development.
Influenza is caused by a virus that attacks mainly the upper respiratory tract - the nose, throat and bronchi, and rarely the lungs. In the very young, the elderly and people suffering from medical conditions such as lung diseases, diabetes, cancer, kidney or heart problems; influenza poses a serious risk. In these people, the infection may lead to severe complications of underlying diseases, pneumonia and death.
Influenza rapidly spreads around the world in seasonal epidemics and imposes a considerable economic burden in the form of hospital and other health care costs and lost productivity.
The genetic makeup of influenza viruses allows frequent minor genetic changes, known as antigenic drift, and these changes require annual reformulation of influenza vaccines.
The most recent pandemics are thought to have arisen in China which has become known as the "epicenter" for the origin of pandemic influenza viruses. The 1957 epidemic (H2N2) became known as the "Asian Flu" pandemic. The 1968 (H3N2) pandemic became known as the "Hong Kong flu".
Vaccination is the principal measure for preventing influenza and reducing the impact of epidemics.
Sinovac Biotech Ltd. is a world leader in the research, development, manufacture and commercialization of vaccines for endemic and pandemic viruses such as hepatitis and influenza, and for fast emerging viruses such as SARS and avian influenza (bird flu). The Company's objective is to provide Chinese children with the best vaccines in the world, and let children in the world use vaccines made in China.
Additional information about Sinovac is available on the Company website, http://www.sinovac.com
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Sinovac Biotech Ltd. (AMEX:SVA - News)
Sinovac Biotech Ltd.
Craig H. Bird
(215) 782-8682 or Toll Free: 1-866-360-8682 (North America)
Source: Sinovac Biotech Ltd.
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.