SFOSF - Kite joint venture gains first CAR T-cell therapy approval in China

Kite, a Gilead Company (GILD), announces that Fosun Kite Biotechnology Ltd., a joint venture between Kite and Shanghai Fosun Pharmaceutical (SFOSF), has received approval in China for axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma ((LBCL)) after two or more lines of systemic therapy. Axicabtagene ciloleucel is the first and only 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 from Kite. The approval is based on results of a single-arm, open label, trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876 in the treatment of Chinese patients with non-Hodgkin's lymphoma/LBCL in China.

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Kite joint venture gains first CAR T-cell therapy approval in China