Qihan Bio's Off-the-Shelf Dual-Target CAR-T Therapy QT-019B Receives FDA RMAT and Breakthrough Therapy Designation

On June 11, Hangzhou Qihan Biotech Co., Ltd. announced that its independently developedUniversal Dual-Target CAR-T ProductQT-019B has officially received dual designation from the U.S. FDA as a Regenerative Medicine Advanced Therapy (RMAT) and a Breakthrough Therapy (BTD). This marks another milestone for the product following its receipt of FDA Fast Track Designation (FTD) in November 2025, making QT-019B a cell therapy product that has simultaneously secured all three FDA expedited review pathways: FTD, RMAT, and BTD.

According to public information from Hangzhou Qihan Biotech Co., Ltd., QT-019B cell injection is an "off-the-shelf" allogeneic CAR-T cell product that can stably express two different chimeric antigen receptors (CARs), targeting CD19 and BCMA respectively. This enables the product to simultaneously recognize and eliminate cells expressing CD19 and BCMA. To reduce the risk of graft-versus-host disease, QT-019B eliminates T-cell receptor (TCR) expression through gene knockout; to minimize allogeneic immune rejection, Hangzhou Qihan Biotech achieves low immunogenicity via multi-gene editing, thereby reducing NK cell and T cell-mediated recognition and cytotoxic effects in patients.

References:
[1] Major Breakthrough! FDA “Double Winner”: Qihan Biotech’s QT-019B Receives Dual RMAT and BTD Designations. From https://mp.weixin.qq.com/s/BMXmp1Q5dtbx6juTdNu9Cw

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