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Sinovac Biotech Submits Clinical Trial Application to SFDA for Pneumococcal Conjugate Vaccine (PCV)
Date:3/3/2011

da Gates Foundation is helping create and implement the Advance Market Commitment (AMC) for Pneumococcal Vaccines, which aims to stimulate the late-stage development and manufacture of suitable and affordable vaccines against pneumococcus for developing countries.

Dr. Weidong Yin, Chairman & CEO, commented, "The clinical trial application for PCV marks the significant progress we have made in advancing the research and development of a pneumococcal conjugate vaccine. During the pre-clinical studies, we made significant technical breakthroughs including establishing a seeds bank, developing the production process and testing methods, completing the production and quality control testing of vaccine doses for the clinical trials application and completing the safety evaluation in animals, which demonstrated the good safety and immunogenicity profile in animals."

Dr. Yin continued, "PCV is one of the vaccine products recommended by WHO to be purchased by United Nation agencies to supply to the developing countries and it is on the list of WHO prequalified vaccines. And we are happy to see that China SFDA passed WHO the evaluation on its vaccine regulatory system, which will enable Chinese vaccine products to be prequalified by the WHO and speed up the process of our vaccine products entering into the international market. With both PCV and PPV under development, Sinovac is poised to provide broader protection against pneumonia to all age groups both in China and around the globe as we further implement our mission to supply vaccines to eliminate human diseases."

Sinovac is also developing another type of pneumococcal vaccine, a pneumococcal polysaccharides vaccine (PPV), which targets children over 2 years old and adults in all age groups, especially the elderly over 65 years old. Sinovac has completed the pre-clinical studies and submitted the clinical trial applications for 23-valent and 24-valent PPVs to SFDA on January 31, 2011.

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SOURCE Sinovac Biotech Ltd.
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