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.”