当前地点:

EN

选择地点:

Sinovac Receives Certificate of Approval to Distribute PANFLU.1 (H1N1) in Mexico

2009-10-22

First China-Developed Vaccine Approved for Human Use in Mexico

BEIJING, Oct. 22 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China, today announced that it has received a Certificate of Approval from the Secretaria de Salud to distribute PANFLU.1, its H1N1 pandemic influenza (swine flu) vaccine, in Mexico. The certificate is valid through October 13, 2014. Laboratorios Imperiales S.A. de C.V., a biopharmaceutical company with operations in Mexico since 1935, is the exclusive distributor of Sinovac's vaccine products in the Mexican market, pursuant to a prior distribution agreement signed in 2005 with its affiliate. The application for Anflu was filed in Mexico as well.

PANFLU.1 is the first China-developed vaccine approved for human use in Mexico and the first H1N1 vaccine to be registered in Mexico. Sinovac will need to obtain permission from the Chinese government prior to exporting its H1N1 vaccine to Mexico. Sinovac is in the process of fulfilling existing orders for a total of 6.3 million doses of PANFLU.1 for the Chinese central government. As previously announced, Sinovac expects to complete the delivery of 4.5 million doses to the Chinese central government by the end of October.

Mr.  Weidong Yin, Chairman, President and CEO of Sinovac, commented, "Receiving the certificate of approval to distribute PANFLU.1 in Mexico is a significant milestone for Sinovac. Importantly, this approval is a continuation of our corporate strategy to register and distribute our vaccines in international markets through strategic collaborations. We appreciate the ongoing efforts of our distribution partner, Laboratorios Imperiales, who has worked closely with the Mexican authorities to obtain this certificate of approval. We will continue to collaborate closely with authorities in China and Mexico in order to facilitate the distribution of PANFLU.1, and potentially other vaccines in our portfolio, in this important market."

To date, there have been 45,809 confirmed cases of H1N1 pandemic influenza in Mexico, of which 271 have died.

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 vaccine products include Healive(R) (hepatitis A), Bilive(R) (combined hepatitis A and B), and Anflu(R) (influenza). Panflu(TM), Sinovac's pandemic influenza vaccine (H5N1), has already been approved for government stockpiling. Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, Japanese encephalitis, and human rabies. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines.

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 x9871
Fax:   +86-10-6296-6910
Email: info@sinovac.com
    Investors:
Amy Glynn/Stephanie Carrington
The Ruth Group
Tel:   +1-646-536-7023/7017
Email: aglynn@theruthgroup.com
            scarrington@theruthgroup.com
    Media
Janine McCargo
The Ruth Group
Tel:   +1-646-536-7033
Email: jmccargo@theruthgroup.com

About SINOVAC

 

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, 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, varicella, influenza, poliomyelitis, pneumococcal disease, and mumps.

 

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 was 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 new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

 

For more information, please see the Company’s website at www.sinovac.com.

 

Contact:

Sinovac Biotech Ltd. 

PR Team 

pr@sinovac.com