Qihan Bio's Off-the-Shelf Dual-Target CAR-T Product QT-019C Receives FDA IND Approval for Autoimmune Diseases with Reduced Lymphodepletion
Qihan Biotech
Gene Editing Technology Developer
May 16, 2026
eMedClub News
Hangzhou, China, May 15, 2026 — Hangzhou Qihan Biotech Co., Ltd., a company dedicated to applying high-throughput gene editing technologyA biotechnology company in the fields of cell therapy and organ transplantation, aiming to provide safe, effective, scalable, and globally accessible treatment solutions for patients suffering from serious diseases.
Yesterday,Qihan BiotechOfficially announced, itsQT-019C, independently developed with global rights, receives approval from the U.S. Food and Drug Administration（FDA）NewDrug Clinical Trial Application（IND）ApprovalThis product is a universal CAR-T cell therapy independently developed by Hangzhou Qihan Biotech Co., Ltd., and has now advanced to the clinical application stage. The core advantage of QT-019C lies in reducing or even eliminating the need for lymphodepletion chemotherapy pretreatment, minimizing reliance on traditional lymphodepletion regimens through technological innovation, achieving low or no lymphodepletion cell therapy, providing patients with a safer and more convenient treatment option. This also marks another key advancement for the company in the field of next-generation off-the-shelf cell therapies.
In response to the multiple industry challenges faced by current universal cell therapies, QT-019C starts from clinical needs and completes three core innovative upgrades, aiming to provide a next-generation treatment solution that requires fewer lymphodepletion, is safe and effective, and is reasonably priced.
QT-019C Truly Achieves "Off-the-Shelf" Supply
Significantly shorten patient waiting time, making the clinical infusion process more convenient and efficient.
Low-Clearance Preprocessing, Significant Improvement in Safety
Unlike existing universal products that require pre-treatment with lymphodepleting chemotherapy, QT-019C explores a low lymphodepletion pre-treatment approach, effectively reducing treatment-related toxic side effects and providing patients with a safer treatment option. This is especially beneficial for young female patients, elderly patients, those with weaker constitutions, or those unable to tolerate chemotherapy, offering them a more patient-friendly treatment alternative.
Comprehensive Functional Enhancement, Reshaping the Treatment Landscape
Through innovative structural and functional enhancement design, QT-019C has achieved significant improvements in key functional indicators such as targeted recognition, rejection resistance, and activation proliferation. It is expected to bring better clinical benefits to patients with autoimmune diseases and promote the use of universal CAR-T cell therapy for autoimmune diseases.(UCAR-T4AID)Entering a safer and more inclusive new stage of development.
About QT-019C
QT-019C Cell Injection is an "off-the-shelf" allogeneic CAR-T cell product developed by Hangzhou Qihan Biotech Co., Ltd. QT-019C cells are derived from the leukapheresis products of healthy donor peripheral blood as the starting raw material, and are genetically edited to stably express two different chimeric antigen receptors. (CAR), targeting CD19 and BCMA respectively, thereby enabling QT-019C to simultaneously recognize and eliminate cells expressing CD19 and BCMA.
To reduce graft-versus-host disease (GvHD) Risk: The product eliminates T-cell receptors through gene knockout.(TCR)Expression; To reduce allogeneic immune rejection, Qihan Biotech achieved low immunogenicity through multi-gene editing. The expression of functional enhancement elements further strengthened the expansion and persistence capabilities of T cells. These mechanisms significantly improved the survival rate of QT-019C cells in patients, reduced immune-mediated adverse events, thereby enhancing the safety and efficacy of QT-019C injection.
About Qihan Biotech
Hangzhou Qihan Biotech Co., Ltd. is a clinical-stage biotechnology company headquartered in Hangzhou, China. It was co-founded by Dr. Luhan Yang and Professor George Church. The company advances the clinical translation of universal cell therapies through multi-gene editing, synthetic biology, and a scalable GMP manufacturing system. Qihan Biotech's mission is to provide safe, effective, and immune-privileged universal cell therapy products, making innovative treatments accessible to patients worldwide. For more information about Qihan Biotech, please visit the company’s official website at www.qihanbio.com.
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