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.
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: email@example.com .
Safe Harbor Statement
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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.