Sinovac Provides Update in Pandemic Influenza Vaccines (H5N1) Phase II Clinical Trials
Monday November 19, 8:00 am ET
BEIJING, Nov. 19 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (Amex: SVA
), a leading provider of biopharmaceutical products in China, today announced an update on the clinical trials for its pandemic influenza vaccines. Sinovac received approval in April 2007 from the China State Food and Drug Administration (SFDA) to commence Phase Ib and II trials of its pandemic influenza (H5N1) whole viron inactivated vaccine and Phase I and II trials of its pandemic influenza (H5N1) split vaccine.
In the pandemic influenza whole viron vaccine Phase II trial, a total of 402 enrolled volunteers from 18 to 60 years old were vaccinated with doses of 5ug, 10ug or 15ug. In accordance with the Phase II trial protocol, all of the volunteers were vaccinated with two doses and followed for an observation period. There were no serious adverse events.
In the Phase I and Phase II trials for the split pandemic influenza vaccine, 160 volunteers from 3 to 70 years old, sorted into four different age groups, were enrolled. The volunteers received doses of 5ug, 10ug, 15ug or 30ug and were followed for an observation period. There were no serious adverse events.
Separately, Sinovac's external auditors are currently reviewing the Company's third quarter financial results, which the Company plans to disclose thereafter. Pertaining to the Annual General Meeting of Shareholders originally scheduled for August 2007, the Company did not receive at that time sufficient shareholder votes, given the geographical nature of its shareholders, to achieve a quorum, as per its corporate by-laws. Sinovac is diligently working to reschedule its Annual General Meeting.
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, and Japanese encephalitis. Additional information about Sinovac is available on its website, http://www.sinovac.com
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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: +86-10-8289-0088 x871
Stephanie Carrington/ Janine McCargo
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.