Lion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations

SINGAPORE and GUANGZHOU, China , Sept. 14, 2025 /PRNewswire/ -- Lion TCR, a clinical-stage biotechnology company pioneering T-cell receptor (TCR)-based therapies, today announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate phase1b/2 clinical trials for its proprietary TCR-T cell therapy, LioCyx-M004, in patients with chronic hepatitis B (CHB). This approval represents the third major regulatory milestone for the same product candidate, which previously received both Fast Track and Orphan Drug Designations for the treatment of hepatitis B virus-related hepatocellular carcinoma (HBV-HCC).

The IND clearance authorizes Lion TCR to commence clinical studies of LioCyx-M004 in CHB patients – a global populatio