2026-05-26

Innovation Frontiers | Universal Dual-Target CAR-T Enters Clinical Validation as FKC389 Completes First Subject Infusion

Recently, Fosun Kairos's universal BCMA/CD19 dual-target CAR-T product, FKC389, achieved a key breakthrough:


· Recently, the study kick-off meeting for this project, targeting the indication of relapsed/refractory plasma cell dyscrasias, was successfully held at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences. Attending experts expressed strong interest in and recognition of the project. Following the meeting, patient screening and enrollment were initiated. This signifies that the clinical translation of this product for blood disorders has entered an accelerated phase.

· On May 26, the first subject successfully received the infusion of FKC389, representing a critical step forward for the project from “study initiation” to “clinical validation”.

· Currently, patient recruitment for the study is in full swing, and the pace of clinical development is continuously accelerating.

 

The successive achievement of these milestones indicates that the Company has entered a substantial advancement phase in the field of “off-the-shelf” cell therapy.


In the field of oncology, CAR-T therapy has offered a new lease on life to many patients with relapsed/refractory hematological malignancies. However, traditional autologous CAR-T therapies are “tailor-made” and produced individually for each patient, resulting in limitations such as lengthy production cycles and exorbitant costs, which restrict their broader application. In view of this, universal CAR-T (UCAR-T), heralded as an “off-the-shelf” therapy, has emerged. It holds the promise of being mass-produced in advance like conventional drugs, readily available whenever patients need it. Moreover, its cost may be only one-sixth to one-tenth that of autologous CAR-T, thereby significantly enhancing treatment accessibility and efficiency.


The successful development of FKC389 not only demonstrates Fosun Kairos's technical expertise and engineering capabilities in the cell therapy field but also signifies that the Company's strategic positioning in the cutting-edge track of universal CAR-T is becoming increasingly clear. As clinical study progresses, it is expected to provide a highly accessible and efficient novel solution for the treatment of blood disorders.


Looking ahead, Fosun Kairos will continue to focus on unmet clinical needs, accelerate the development of innovative therapies, enhance their accessibility, and help cell therapy truly enter the “era of accessibility”.