US EditionLion TCR Achieves Triple FDA Milestones with IND Clearance for Chronic Hepatitis B Following Earlier Fast Track and Orphan Drug Designations
- Lion TCR received Investigational New Drug clearance from the U.S. Food and Drug Administration for LioCyx-M004 to treat chronic hepatitis B in patients.
- This approval is Lion TCR's third major regulatory achievement after Fast Track and Orphan Drug designations for hepatitis B virus-related hepatocellular carcinoma.
- LioCyx-M004 is an innovative T-cell therapy that has shown promise in early studies by reducing viral antigen load and aiding T-cell-mediated clearance of infected cells.
- Dr. Xiaoming Peng stated that the triple recognition from the FDA showcases the potential of LioCyx-M004 targeting HBV-associated diseases.
34 Articles
34 Articles
The Berkshire Eagle
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…
Lion TCR Scores Triple FDA Win 2025, IND Cleared for HBV TCR Therapy
SINGAPORE and GUANGZHOU, China, Sept. 15, 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 …
Coverage Details
Bias Distribution
- 58% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
