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YIKAIDA

Axicabtagene Ciloleucel Injection

On June 22, 2021, YIKAIDA (Axicabtagene Ciloleucel Injection), a CD19 CAR-T product developed by Fosun Kairos, was officially approved for marketing in China. It is indicated for adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) who have received two or more lines of prior systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

YIKAIDA is autologous CD19-targeted human CAR-T cell therapy product granted authorization for localized production in China. It is developed by Fosun Kairos through a successful technology transfer and licensing of Yescarta® (Axi-Cel) from Kite Pharma (U.S.) — the world's first approved CAR-T product for Non-Hodgkin Lymphoma. As China's first CAR-T cell therapy product approved for marketing through the drug regulatory pathway, YIKAIDA is not just a treatment, but a one-time, personalized medicine. It offers a predictable path toward a cure and has already treated over 1500 lymphoma patients to date.

On June 21, 2023, NMPA officially approved Fosun Kairos' application for the new indication for YIKAIDA. This means the medicine can now available to adult patients with Large B-cell Lymphoma who failed to respond to first-line chemoimmunotherapy or relapsed within 12 months of initial treatment. This approval accelerates access to a potential cure for those in urgent need.