On September 25, 2026 Jecho Biopharmaceuticals (Tianjin) Co., Ltd. ("Jecho") reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for JL19001 Injection, a Class 1 innovative drug developed in-house. The clearance allows Jecho to begin overseas clinical trials of JL19001 in a new indication, advancing the product’s global development and further demonstrating the company’s research capabilities in immuno-oncology.
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JL19001 Injection is a core program in Jecho’s immuno-oncology portfolio. JL19001 is a recombinant fusion protein composed of human serum albumin (HSA) and IL-15Rα/IL-15. It has a distinctive mechanism of action, as it specifically activates natural killer (NK) cells and CD8+ T cells, strengthening both the innate and adaptive immune responses.
The newly cleared indication by the FDA covers advanced solid tumors and relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). It is the second indication for which JL19001 has received clinical trial approval. In March 2026, China’s Center for Drug Evaluation (CDE) approved clinical trials for this indication. This additional clearance expands the product’s potential clinical applications and opportunities for business partnerships.
The program has already reached several key milestones:
September 2025: JL19001 received CDE clinical trial approval for non-muscle invasive bladder cancer (NMIBC), its first IND approval in China.
November 2025: The FDA cleared the IND for NMIBC, enabling simultaneous clinical development in China and the United States.
Going forward, Jecho will accelerate its clinical trials in China and abroad and build on its innovation to deepen industry collaborations. The company aims to bring new treatment options to more cancer patients and to advance immuno-oncology therapeutics.
(Press release, Jecho Laboratories, SEP 25, 2026, View Source [SID1234671089])