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Sinovac Receives SFDA's Approval for Pandemic Influenza H5N1 Vaccine
Sinovac Receives China State Food and Drug Administration (SFDA) Approval for Pandemic Influenza H5N1 Vaccine
Wednesday April 2, 8:00 am ET
Mr. Weidong Yin, Chairman, President and CEO, stated, "The SFDA's approval of Panflu is an important milestone for Sinovac. Our clinical development team has devoted significant effort over the past four years and we are proud of this achievement. Sinovac is the only company in China that has successfully completed clinical trials for a pandemic influenza vaccine candidate, submitted the results to the SFDA, and received regulatory approval of production license. The government of China has indicated publicly their intention to stockpile the vaccine in advance of the Olympic Games in Beijing this summer. Sinovac is committed to working closely with the regulators and the government to develop and implement the national stockpiling program for the pandemic influenza vaccine."
Sinovac previously announced positive top-line results of a randomized, double-blind, Phase II clinical trial of its pandemic influenza (H5N1) vaccine at the end of 2007. The Phase II clinical trial results were submitted in February 2008 to the SFDA.
Sinovac commenced the development of a pandemic influenza vaccine in 2004. In June 2006, the Phase I clinical trial results indicated good immunogenicity and safety. In September 2006, the results were published in "The Lancet," an independent medical journal.
About Sinovac
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 vaccines include Healive(TM) (hepatitis A), Bilive(TM) (combined hepatitis A and B) and Anflu(TM) (influenza). Sinovac is currently developing human vaccines against the H5N1 strain of pandemic influenza, Japanese encephalitis and SARS. Additional information about Sinovac is available on its website, http://www.sinovac.com . To be added to our distribution list, please email: info@sinovac.com .
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: +86-10-82890088 Ext. 871 Fax: +86-10-62966910 Email: info@sinovac.com Investors/Media Contact: Stephanie Carrington The Ruth Group Tel: +1-646-536-7017 Email: scarrington@theruthgroup.com Janine McCargo The Ruth Group Tel: +1-646-536-7033 Email: jmccargo@theruthgroup.com
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of "supply vaccines to eliminate human diseases", the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.
The company's diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.
SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world's first inactivated SARS vaccine (Phase I completed), China's first H5N1 influenza vaccine (Paneflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.
Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines,recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.
With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.
For more information, please see the Company’s website at www.sinovac.com.