Development History
In January, Fosun Kairos' IND application for FKC289 Injection, an autologous dual-target CAR-T product, was officially accepted by the NMPA. The application covers indications for relapsed/refractory primary AL amyloidosis (ALA) and membranous nephropathy (MN).
In May, Fosun Kairos completed the first patient infusion for its universal dual-target CAR-T product, FKC389.
In June, YIKAIDA celebrated the fifth anniversary of its commercial launch. Since its launch, YIKAIDA has treated over 1,500 patients with relapsed/refractory lymphoma. Notably, Ms. Qin, the first patient to receive CAR-T therapy in China, has achieved over eight years of cancer-free survival and maintains complete remission.
In March, YIKAIDA completed China's first cross-border (Hong Kong, China) transportation and clinical use of a CAR-T therapy.
In September, the blood sample from the first lymphoma patient in Macao (China) arrived safely in Pudong, Shanghai, marking the commencement of YIKAIDA manufacturing.
In September, the drug registration application for Fosun Kairos' second CAR-T product, brexucabtagene autoleucel injection, was officially accepted by the NMPA, for the proposed indication of relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).
In December, YIKAIDA was included in the first edition of Commercial Health Insurance Innovative Drug Catalog (2025).
In January, Fosun Kairos, in collaboration with Medi Cover, a subsidiary of Sinopharm Group, launched China’s first outcome-based value payment plan for lymphoma with YIKAIDA.
On June 21, the sNDA for new indications for YIKAIDA was officially approved by the National Medical Products Administration. It is indicated for adult patients with large B-cell lymphoma refractory to first-line chemoimmunotherapy or relapsing within 12 months thereof.
In October, the application for a new second-line indication for YIKAIDA was accepted by the CDE under NMPA.
On June 22, Fosun Kairos' CD19 CAR-T product, Axicabtagene Ciloleucel Injection (trade name: YIKAIDA), was officially approved for marketing in China for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This makes it the first CAR-T cell therapy product approved for marketing through the drug regulatory pathway in China.
In February, the NDA for FKC876 was accepted by the NMPA, and it was granted Priority Review status the following month.
In March, Fosun Kairos' first commercial manufacturing base was established in Shanghai Tianci International Biological Industrial Park, and officially commenced construction.
In June, the Company’s cell therapy R&D center was put into operation to advance early-stage R&D and evidence-based clinical projects.
In December, the Tianci commercial manufacturing base was officially inaugurated, kicking off the industrialization process of CAR-T in China.
In May, technology transfer, process validation and comparability studies were completed, followed by the application for clinical trial registration.
In August, the IND application for Axicabtagene Ciloleucel was approved by the NMPA.
In November, the first Chinese patient was enrolled in the CAR-T clinical trial and received treatment, marking a key step forward in curative treatment exploration.
In April, Fosun Kairos was officially established, initiating the technology transfer and localization development process.
In December, the GMP-compliant preparation base for clinical samples was finished, along with the completion of Yescarta® technology transfer.


