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Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel Accepted for Review by China NMPA

02-25 2020

(24 February, 2020, Shanghai) Today, Fosun Kite Biotechnology(“Fosun Kite”) based in Shanghai, a company invested by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK), announced its New Drug Application (NDA) filing for CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) has been accepted for review by China National Medical Products Administration (NMPA) 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 (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR-T cell therapy manufactured in China with the technology of YESCARTA® (Axicabtagene Ciloleucel) transferred from Kite Pharma, a Gilead Company. 

The principle of autologous CAR-T cell therapy is to genetically modify patient’s T-cells to express a chimeric antigen receptor (CAR) that will activate T-cells upon engaging cells carrying the specific antigen on the surface and conduct killing. FKC876 targets the B-cell specific antigen CD19 for treating B-cell malignancies. This NDA filing is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which has evaluated the efficacy and safety of FKC876 in the treatment of Chinese patients with refractory intermediate invasive non-Hodgkin's lymphoma (NHL)/ large B-cell lymphoma in China. 

William Wu, President and CEO of Fosun Pharma, President of Fosun Kite, said, “FKC876 is Fosun Kite’s first CAR-T cell therapy product to be commercialized in China; it’s also the first NDA filing accepted for any CAR-T product in China so far. As a breakthrough cancer treatment, FKC876 brings hope and chance to live to patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy in China. This acceptance also gives us confidence to bring more world-leading cell therapies to China and further invest in innovation.”

Richard Wang, CEO of Fosun Kite, commented, “We really appreciate the openness and innovation of NMPA in regulating CAR-T cell therapies. This acceptance means a preliminary recognition of our manufacturing process, quality control and clinical efficacy of FKC876. As a leader for immune cell therapy commercialization in China, we believe once approved FKC876 will change the way lymphoma patients are treated in China. Meanwhile, we look forward to working closely with government agencies, hospitals, charity foundations and commercial insurances to explore new approaches of patient assistance programs and payment models to ease patient financial burden, thus benefiting more lymphoma patients in China.”