Qihan Bio Announces FDA IND Approval of QT-019B, the First Universal Dual-Target CAR-T Therapy for Autoimmune Diseases Developed by a Chinese Company

Aug 15, 2025 10:32 CST Updated 10:32

Qihan Biotech

Gene Editing Technology Developer

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August 13 — Hangzhou Qihan Biotech Co., Ltd. announced that the Investigational New Drug (IND) application for its first self-developed universal dual-target CAR-T cell product, QT-019B, has been officially approved by the U.S. Food and Drug Administration (FDA).

QT-019B is the first universal CAR-T cell product independently developed by a Chinese company for the treatment of autoimmune diseases to receive FDA approval for clinical trials in the United States. The company plans to conduct a Phase 1/2 clinical trial of QT-019B for the treatment of refractory systemic lupus erythematosus (rSLE) in the United States, with the primary clinical research site being the Hospital of the University of Pennsylvania.

QT-019B is the first allogeneic CAR-T cell product independently developed by the company with global rights. Currently, in clinical studies initiated by investigators in China, this product has demonstrated promising clinical efficacy against various refractory autoimmune diseases, including rSLE. Considering multiple factors,Qihan BiotechDecision to prioritize the development of QT-019B for the indication of refractory systemic lupus erythematosus. Hangzhou Qihan Biotech Co., Ltd. is also honored to have established a collaboration with Dr. Carl June's team at the University of Pennsylvania and the Rheumatology and Immunology Department.

[About QT-019B]

QT-019B Cell Injection is an "off-the-shelf" allogeneic CAR-T cell product developed by Hangzhou Qihan Biotech Co., Ltd. QT-019B cells are derived from the leukapheresis products of healthy donor peripheral blood as the starting material, and are genetically edited to stably express two different chimeric antigen receptors (CARs), targeting CD19 and BCMA respectively, thereby enabling QT-019B to simultaneously recognize and eliminate cells expressing CD19 and BCMA.

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Qihan Biotech