Fosun Kairos, a subsidiary of Fosun Pharma, has recently notched a string of key breakthroughs in cell therapy, covering accelerated clinical advancement and growing international academic recognition, marking the continuous rapid progress of the Company’s innovative pipeline.

In terms of clinical development, FKC289, our autologous dual-target BCMA/CD19 CAR-T candidate, has secured multiple significant milestones. On April 22, the national investigator meeting for its Phase I/II trial in relapsed/refractory primary light chain amyloidosis (R/R ALA) was successfully convened. Participants discussed trial protocols and detailed implementation plans, reaching consensus on multi-center collaborative research. Shortly after, the national investigator meeting and study initiation ceremony for FKC289 targeting relapsed/refractory membranous nephropathy (R/R MN) were held on April 29, signifying its rapid foray into the field of autoimmune diseases. Patient enrollment for the above trials is now well underway.

Academically, two latest research works have been accepted for presentation at the 31st European Hematology Association Annual Congress (EHA 2026). One centers on the ctDNA-guided strategy for early second Axi-cel infusion, exploring precise intervention approaches for relapsed/refractory large B-cell lymphoma. The other focuses on evaluating the safety and efficacy of FKC289, our autologous dual-target BCMA/CD19 CAR-T therapy, in patients with relapsed/refractory primary light chain amyloidosis (R/R ALA).

EHA 2026 will be grandly held in Stockholm, Sweden from June 11 to 14, 2026 (local time). As one of the most influential academic conferences in global hematology, the EHA Annual Congress serves not only as a premier platform for presenting cutting-edge research outcomes, but also as a key hub for driving advances in diagnosis and management and promoting international collaboration.

The acceptance of the two studies demonstrates Fosun Kairos’ sustained commitment to exploring innovative mechanisms and advancing clinical translation, and will enable our research achievements to gain wider exposure and recognition on the global academic stage.

Details of Accepted Studies

Axi-cel (CD19 CAR-T)

CD19 CAR-T therapy has substantially improved treatment outcomes for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL). Nevertheless, patients who fail to achieve deep remission after the first infusion still face high relapse risks. Previous clinical data indicates that second-line CAR-T infusion administered after disease relapse or progression yields limited salvage efficacy. This study aims to evaluate the efficacy, safety and cellular kinetic characteristics of early second CD19 CAR-T infusion as consolidation therapy in R/R LBCL patients who obtain partial response rather than deep remission after initial infusion.

Abstract Title: A Prospective, Single-Arm Clinical Study of ctDNA-Guided Early Second Infusion of Axi-Cel in Relapsed/Refractory Large B-Cell Lymphoma
Presentation Type: Oral Presentation
Abstract ID: EHA-5136
Presentation Date: June 11-14, 2026
Principal Investigators: San-fang Tu, Kai-xin Ou, Lei Wang, Zhao Liang, Yan-jie He, Shao-jie Wu, Ji-long Yang, Chun-yan Yue, Tian-you Yan, Yu-hua Li

FKC289 (BCMA/CD19 CAR-T)

There remains a huge unmet clinical need in the treatment of relapsed/refractory primary light chain amyloidosis (R/R ALA). As an autologous dual-target CAR-T therapy targeting both BCMA and CD19, FKC289 can profoundly deplete pathogenic plasma cells and/or B cells by binding to their surface antigens. It inhibits the production of monoclonal immunoglobulin light chains and misfolded amyloid proteins, so as to alleviate tissue and organ damage. This investigator-initiated first-in-human Phase I trial (IIT, ChiCTR2500100410) is designed to assess the safety and preliminary efficacy of dual BCMA/CD19-targeted CAR-T FKC289 in patients with R/R ALA.

Abstract Title: Safety and Efficacy of Autologous Dual Targeting BCMA/CD19 CAR-T FKC289 in Subjects with Relapsed / Refractory Light Chain Amyloidosis
Presentation Type: Poster
Abstract ID: PF852
Presentation Date: June 11-14, 2026
Principal Investigators: Jing Li, Shi-yang Gu, Yu-hong Ren, Yang Yang, Jia-dai Xu, Yi-an Zhang, Tian-hong Xu, Xiao-chen Wang, Gong-xina Jia, Zi-song Zhou, Wen Shi, Peng Liu

The simultaneous progress of multiple accepted studies and clinical trials further validates Fosun Kairos’ systematic capabilities spanning fundamental research and clinical application in the CAR-T sector.

Moving forward, Fosun Kairos will continue to focus on unmet clinical needs, accelerate the development of innovative therapies and improvement of their accessibility, and advance more breakthrough outcomes to benefit patients.