Qihan Bio's Off-the-Shelf Dual-Target CAR-T Therapy QT-019B Receives FDA IND Approval for Refractory Systemic Lupus Erythematosus

On August 13, Hangzhou Qihan Biotech Co., Ltd. announced that its self-developed firstUniversal Dual-Target CAR-T Cell ProductThe IND application for QT-019B has been officially approved by the U.S. FDA. Hangzhou Qihan Biotech Co., Ltd. plans to conduct QT-019B treatment trials in the United States.Refractory Systemic Lupus Erythematosus (rSLE)The Phase 1/2 clinical trial, with the primary clinical research unit being the Hospital of the University of Pennsylvania in the United States.

Dr. Luhan Yang, founder and CEO of Hangzhou Qihan Biotech Co., Ltd., stated that Qihan Biotech has established the development of universal cell therapies for autoimmune diseases as a strategic priority for the company. QT-019B is the first universal CAR-T cell product independently developed by Qihan Biotech, with global rights owned by the company. 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 Biotech has decided to prioritize the development of QT-019B for the rSLE indication. In addition, Qihan Biotech is also developing several iterative innovative products, including specially designed universal CAR-T cell products that do not require lymphodepletion pretreatment.

QT-019B Cell Injection is an "off-the-shelf" allogeneic CAR-T cell product. QT-019B cells are derived from the leukapheresis products of healthy donors' peripheral blood as the starting raw material. Through genetic editing, they 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. To reduce the risk of graft-versus-host disease (GvHD), the product eliminates the expression of T-cell receptors (TCR) through gene knockout. Meanwhile, to reduce allogeneic immune rejection, Hangzhou Qihan Biotech Co., Ltd. achieves low immunogenicity through multi-gene editing, thereby reducing the recognition and cytotoxic effects mediated by the patient's own NK cells and T cells.

References:
[1] Breaking News: Hangzhou Qihan Biotech Co., Ltd.'s First Universal Dual-Target CAR-T Cell Product for the Treatment of Refractory Systemic Lupus Erythematosus (rSLE) Receives Official FDA Approval for New Drug Clinical Trial. From https://mp.weixin.qq.com/s/4rRFLL3dJcMwqi4ksaD7Wg

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