Qihan Biotech Announces FDA Clearance of IND for QT-019B, a Universal Dual-Target CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus

Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for QT-019B. This universal, dual-target CAR-T cell therapy is designed to treat refractory systemic lupus erythematosus (rSLE), and the clearance enables the initiation of a Phase 1/2 clinical trial in the United States, marking a significant milestone in the development of novel cell-based therapies for autoimmune diseases.

“Developing off-the-shelf cell therapies for autoimmune diseases is a core strategic priority for Qihan Biotech,” said Dr. Luhan Yang, Founder and CEO. “QT-019B is our first fully in-house CAR-T therapy with global rights. In investigator-initiated clinical studies in China, it has shown promising results against multiple refractory autoimmune diseases, including systemic lupus erythematosus. Based on a comprehensive assessment of multiple factors, we are prioritizing the development of QT-019B for refractory SLE.”

Dr. Yang added, “Patients with refractory SLE continue to face significant unmet medical needs. With a clear regulatory pathway and a strong likelihood of trial success, Qihan is confident in advancing QT-019B rapidly into clinical studies and registration-enabling trials in pursuit of marketing approval. We have a well-defined global clinical development plan and hope that QT-019B, as a potential breakthrough therapy, can transform the treatment landscape for refractory autoimmune diseases, providing safe, effective, and affordable options for patients worldwide. Beyond QT-019B, the company is developing next-generation off-the-shelf CAR-T therapies that will not require patients to undergo lymphodepletion. We look forward to bringing these therapies into clinical trials and reshaping the global treatment paradigm for autoimmune diseases.”

About QT-019B

QT-019B is an off-the-shelf allogeneic CAR-T cell therapy independently developed by Qihan Biotech. The therapy is derived from healthy donor leukapheresis products and engineered through gene editing to stably express two distinct chimeric antigen receptors (CARs) targeting CD19 and BCMA, enabling simultaneous recognition and elimination of cells expressing either antigen. To reduce the risk of graft-versus-host disease (GvHD), the T cell receptor (TCR) is knocked out. Additionally, multiplexable gene editing is employed to induce hypoimmunity, meaning the CAR-T cells are less likely to be recognized and attacked by the patient’s own NK and T cells, thereby reducing immune rejection and cytotoxicity while enhancing persistence.

About Qihan Biotech

Qihan Biotech is a biotechnology company applying genome editing technology to develop novel cell therapies and organs for transplantation. The company's mission is to use high-throughput, multiplexable genome editing combined with expertise in transplantation immunology to create immunologically privileged allogeneic cells and xenogeneic organs for use as therapies to treat cancer, autoimmune diseases, organ failure, and other complex medical conditions. With a vision to create a world in which cell and organ therapies are universally available to patients, Qihan Biotech has raised two financing rounds. It has multiple products at different stages of development, including QN-019a, which had already received IND approval from China NMPA to treat CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Qihan's deep scientific experience and technology advancements have enabled the company to create cutting-edge cell therapy products. Qihan Biotech is headquartered in Hangzhou, China. For more information, please visit the company's website at www.qihanbio.com.

Forward-looking Statements

This release contains statements including, but not limited to, Qihan’s research development and/or relevant programs, its past, ongoing, and planned research studies, and the potential of Qihan’s research candidate. These and any other statements in this release are based on Qihan management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such statements. These risks and uncertainties include, but are not limited to, the risk that Qihan’s research program may not warrant further development, the risk that results observed in prior studies of Qihan’s research candidates will not be observed in ongoing or future studies involving these candidates, the risk of a delay or difficulties in the developing or transforming of Qihan’s research candidates, the risk that Qihan may cease or delay the research development of any of its candidates for a variety of reasons. Qihan is providing the information in this release as of this date and does not undertake any obligation to update any statements contained in this release as a result of new information, future events, or otherwise. Information concerning therapies and related products contained herein is not intended as medical advice.

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