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.
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