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Fosun Kite Initiates the Manufacturing of FDA-approved CAR-T Product Yescarta in China to Follow Chinese Regulatory Path

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December 5, 2017, Fosun Kite Biotechnology Co., Ltd. (“Fosun Kite”) inaugurated a manufacturing facility for cancer cell therapy in Zhangjiang, Shanghai.

 

Fosun Kite is a joint venture between Fosun Pharma and Kite Pharma based in Shanghai.

 

In December 2017, Fosun Kite established an advanced cell therapy manufacturing facility under the national standards of Good Manufacturing Practices (GMP) and under Kite Pharma’s technology and facility design. Fosun Kite will now accelerate the technology transfer, validation and registration of Kite’s first FDA-approved product, KTE-C19 (trade name “Yescarta").

 

Through Yescarta, Fosun Kite is committed to introducing the world’s cutting-edge CAR-T technology for Chinese cancer patients. Yescarta has the potential to become the first cell therapy product approved for cancer patients in China, which carries great significance and sets standards for commercialization of CAR-T cell therapy.

 

“With CAR-T, we take another major leap in the fight against cancer,” said Mr. Guo Guangchang, Chairman of Fosun International. “Fosun has set up a world class R&D and manufacturing platform in Shanghai through its collaboration with Gilead Science and Kite, and today’s inauguration is testament to Fosun’s continued commitment to bringing the highest quality treatments to Chinese patients.”

 

Mr. Arie Belldegrun, Founder of Kite Pharma, commented, "We are committed to providing advanced tumor cellular immunotherapy to global cancer patients, and Fosun Pharma is our ideal partner in China for promoting Yescarta."

 

On 18 October 2017, Yescarta became the first CAR-T therapy approved by the FDA for treating certain types of large B-cell lymphoma, as well as the first CAR-T filed with the European Medicines Agency (EMA) for listing application.

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