Sinovac Biotech Ltd. Receives Flu Vaccine Production License from Chinese FDA
BEIJING--(BUSINESS WIRE)--July 27, 2005--Sinovac Biotech Ltd. ("Sinovac") ("the Company") (AMEX:SVA - News) announced today that the State Food and Drug Administration (SFDA) issued a production license for Sinovac's proprietary influenza flu vaccine, Anflu(TM).
The SFDA issued a new drug certificate for Anflu(TM) in March 2005, which provided Sinovac proprietary privileges for the vaccine. The production license was received July 27th (Beijing time), and authorizes Sinovac to begin vaccine production.
Sinovac has already installed and tested all the latest production equipment into the facility and is ready to complete the final step in the application process for Good Manufacturing Practices (GMP) certification. Once approved, Sinovac will have three GMP certified state-of-the-art vaccine products selling in China. Sinovac's other two products include Healive(TM), which immunizes against hepatitis A, and Bilive(TM), which immunizes against hepatitis A and hepatitis B.
The Company's new flu production line is situated at a new manufacturing facility next to its existing Beijing headquarters. The 2,600 square-meter facility has a production capacity of 2 million flu vaccine doses per year. This production line can also be used to produce a pandemic influenza (avian flu) vaccine for humans against the H5N1 virus.
Sinovac President and CEO, Mr. Weidong Yin remarked, "this important development demonstrates Sinovac's continued strengths and progress in all fundamental areas. We made a complimentary corporate development plan for developing and commercializing vaccines to combat conventional and emerging viruses. Receiving our third production license is one of the important developments for the company's conventional-side of our plan. Now we are gaining momentum with each success. I am truly excited to show the world all of our tremendous vaccine and business achievements."
Sinovac developed the Anflu(TM) vaccine in response to the fast growing influenza vaccine market in China. It is estimated that yearly influenza vaccine shortfalls will be as much as 15 to 20 million doses. Split type vaccines are the most widely used influenza vaccines due to their higher safety record. Anflu(TM) is a split vaccine and Sinovac intends to establish itself as the market leader for split influenza vaccine production.
With an aging population and a growing health-conscious middle class, the demand for safe and efficacious influenza vaccines is growing by as much as 16% (compounded annual growth rate) per year in China.
Ideally, Anflu(TM) marketing will begin in late summer of 2005, with sales expected to begin in the last quarter of 2005. After it is approved for sales to the public, Sinovac will utilize the same sales and distribution channels as they do for Healive(TM) and Bilive(TM). With the advent of a third major product Sinovac is leveraging their growing name recognition and stellar reputation in the domestic market. The timing of Anflu sales depends on the date the SFDA approves the production line.
In order to comply with China's drug administration regulations, a new vaccine must have both a new drug certificate and a production license before it can apply for GMP certification. Once all three of these requirements are met, the company can mass produce vaccines and sell them.
The New Drug Certificate grants the filing Company intellectual property rights to the drug. In accordance with World Trade Organization (WTO) agreements, Sinovac's latest vaccine now receives global proprietary protection.
About the SFDA
China's State Food and Drug Administration (SFDA), is the highest state authority governing the nation's drug industry. The SFDA's main functions include the approval of drug registrations, the drafting and enforcement of industrial standards, and the issuing of licenses. The role and standing of the SFDA are essentially those of the FDA (Food & Drug Administration) in the United States. Without exception, all local and foreign drugs produced and/or marketed in China are required to meet relevant SFDA standards as a pre-requisite to their regular use and they are strictly bound by SFDA regulations.
About Sinovac Biotech Ltd.
Sinovac Biotech Ltd. is committed to becoming a world leader in the research and 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 Flu Influenza (a.k.a. "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 is available on the Company website, http://www.sinovac.com/en/index.asp
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Sinovac Biotech Ltd. (AMEX:SVA - News)
Sinovac Biotech Ltd.
Craig H. Bird
(215) 782-8682 or Toll Free (North America): 1-866-360-8682
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.