CG101 Secures FDA IND Clearance, Becoming China’s First Gene-Edited iPSC-Based Cell Therapy Product

On August 14, 2026, CG101 Injection, independently developed by Hangzhou Jiyuan Gene for the treatment of acute myeloid leukemia (AML), has been granted Investigational New Drug (IND) clearance by the U.S. FDA, initiating a multicenter Phase I clinical trial. As China’s first approved gene-edited iPSC-derived immune cell therapy product, this milestone signifies the official entry of the company’s universal off-the-shelf cell therapy platform into a new phase of global clinical development.