June 16, 2026 —
Qihan Biotech announced that QT-019B, its internally developed universal dual-target CAR-T therapy, has received both Regenerative Medicine Advanced Therapy designation and Breakthrough Therapy Designation from the U.S. FDA. The new designations follow the therapy’s receipt of Fast Track Designation in November 2025.
According to Qihan, QT-019B is now among a select group of cell therapy products worldwide to have received all three of the FDA’s major expedited development and review designations: Fast Track, RMAT, and Breakthrough Therapy. The company also described QT-019B as the first cell therapy product developed in China to receive this “triple crown” of FDA expedited designations.
QT-019B is an off-the-shelf allogeneic CAR-T cell therapy derived from healthy donor leukapheresis products. The therapy is engineered through gene editing to stably express two distinct chimeric antigen receptors targeting CD19 and BCMA, enabling simultaneous recognition and elimination of cells expressing either antigen.
The product is designed to address several challenges associated with allogeneic cell therapy. To reduce the risk of graft-versus-host disease, the T cell receptor is knocked out. Qihan also uses multiplexable gene editing to induce a hypoimmune phenotype, aiming to reduce recognition and attack by the patient’s own NK cells and T cells. This strategy is intended to limit immune rejection and cytotoxicity while improving CAR-T cell persistence.
RMAT designation is intended to support the development of regenerative medicine products, including cell and gene therapies, that may address serious diseases and show potential to meet unmet medical needs. Benefits can include closer and earlier FDA interactions, rolling review, and potential eligibility for Priority Review and Accelerated Approval.
Breakthrough Therapy Designation is granted to therapies for serious or life-threatening diseases that may demonstrate substantial improvement over existing treatment options based on preliminary clinical evidence. It provides intensive FDA guidance, involvement from senior agency leadership, and potential access to expedited review pathways.
The dual RMAT and Breakthrough designations reflect the FDA’s recognition of QT-019B’s promising early clinical profile, supported by emerging efficacy and safety data. For Qihan, the milestone strengthens the regulatory path for a gene-edited, off-the-shelf CAR-T platform designed to improve accessibility, scalability, and treatment persistence.
The update also highlights the growing global momentum behind universal cell therapy technologies. By combining dual-antigen targeting, TCR knockout, and hypoimmune engineering, QT-019B represents a next-generation allogeneic CAR-T approach that could help broaden access to cell therapy while addressing key barriers such as immune rejection, manufacturing complexity, and relapse driven by antigen escape.
