Hangzhou Qihan Biotech Co., Ltd. (Qihan), has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for QT-019B.
The 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 US, marking a 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 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.
“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.”
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