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 -
News), 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.
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, and Japanese encephalitis. 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:
Contact Information:
Helen G. Yang
Sinovac Biotech Ltd.
Tel: +86-10-8289-0088 x871
Fax: +86-10-6296-6910
Email: info@sinovac.com
Investors/Media:
Stephanie Carrington/ Janine McCargo
The Ruth Group
Tel: +1-646-536-7017/7033
Email: scarrington@theruthgroup.com
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.
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