Sinovac Receives GMP Certificate in Mexico for Seasonal Flu Vaccine and Hepatitis A Vaccine
BEIJING, Aug. 11, 2011 /PRNewswire-Asia/ — Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today that it has obtained the GMP certificate for its seasonal flu vaccine and hepatitis A vaccine from the Mexican regulatory authority, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) of Mexico Ministry of Health. Sinovac is the first Chinese vaccine manufacturer to be granted GMP certificate by COFEPRIS. The GMP certification follows the onsite inspection by COFEPRIS at Sinovac’s Beijing headquarters in September 2010. The GMP certificate is effective for 30 months with an expiration date of January 12, 2014, at which time a new GMP inspection shall be applied for the renewal of GMP certificate. 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.
Mr. Weidong Yin, Chairman, President and CEO, stated, “We are very excited to receive the Mexican GMP certificate, which is a significant milestone as we advance our global commercialization strategy to register our vaccines. In terms of next steps, we plan to submit the additional documentations for our seasonal flu vaccine Anflu, required by COFEPRIS in order to complete the registration process. We anticipate that the Certificate of Approval for Anflu will be granted in the coming months in order to commercially launch the vaccine in Mexico. The Mexican market is regarded by Sinovac as another significant market for Anflu and Healive, outside of China. We look forward to participating in the government tender process as well as private market sales, in collaboration with our partner in Mexico.”
Yin continued, “We plan to initiate the registration process for our inactivated hepatitis A vaccine Healive in Mexico after the Certificate of Approval is granted for Anflu.”
The Certificate of Approval for PANFLU.1, Sinovac’s H1N1 pandemic influenza (swine flu) vaccine, was granted by the Secretaria de Salud, Mexico Ministry of Health, in 2009.
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 including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, PANFLU.1, and has received orders from the Chinese Central Government pursuant to the government stockpiling program. The Company is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against hand, foot & mouth disease), mumps, rubella, HIB, epidemic meningitis, chickenpox and human rabies. Its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines and has completed the field trials for an independently developed inactivated animal rabies vaccine, which is anticipated to be launched in 2011.
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