Fosun Kite Biotechnology Gets CAR T-cell Therapy Approval In China

Fosun Kite Biotechnology Co., Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical Co., Ltd, has received approval from the China National Medical Products Administration for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma or DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma, Kite, a Gilead Company, said in a statement.

Axicabtagene ciloleucel is commercially available chimeric antigen receptor (CAR) T-cell therapy approved in China.

Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR T-cell therapy manufactured in China under a license to YESCARTA (Axicabtagene Ciloleucel) from Kite.

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