In January 2009, the Company's wholly owned subsidiary, Tangshan Yian Biological Engineering Co., Ltd, obtained approval from China's Ministry of Agriculture to conduct field trials of its internally developed inactivated animal rabies vaccine, enabling the Company to enter the veterinary vaccine market in China with a high quality domestically-produced vaccine. Sinovac anticipates that the field trials will take approximately nine months to complete and that the vaccine will be launched in China's veterinary market in 2010.
As reported by media sources in February 2009, the State Food and Drug Administration (SFDA) completed a site inspection of Sinovac in conjunction of the government stockpiling program for Panflu, the pandemic influenza vaccine for which Sinovac holds manufacturing rights, to protect China's residents if an outbreak of human bird flu should occur. The production of the H5N1 vaccine for stockpiling is progressing on schedule.
In March 2009, Sinovac received GMP certification from the SFDA for its new filling and packaging production facility. With the receipt of the GMP certification, Sinovac's annual production capacity increased to 20 million doses, and has the potential to double to 40 million doses. This production milestone ensures that Sinovac can fully meet increasing market demand and potential production increases for currently commercialized products, such as Healive, Bilive and Anflu. The filling and packaging production plant also has the capabilities to fill and package Panflu, in support of the government stockpiling program, as well as products currently in Sinovac's development pipeline upon future launch following regulatory approval.
In 2008, Sinovac initiated the development program of a vaccine against EV
71. Development is progressing on schedule and good achievements have been
made to date. The findi
|SOURCE Sinovac Biotech Ltd.|
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