Lion TCR Receives FDA Clearance for First-in-Class Hepatitis B Cell Therapy

SINGAPORE and GUANGZHOU, China, Sept. 14, 2025 — Lion TCR, a clinical-stage biotechnology company, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to begin Phase 1b/2 clinical trials for its proprietary T-cell receptor (TCR)-based therapy, LioCyx-M004. The trials will target patients with chronic hepatitis B (CHB), a global population exceeding 290 million. This marks the first TCR-T therapy to enter clinical development for the disease.

The IND clearance is the third major regulatory milestone for the product, which previously received both Fast Track and Orphan Drug Designations from the FDA for the treatment of hepatitis B virus-related hepatocellular carcinoma (HBV-HCC).

“This triple recognition from the FDA underscores the transformative potential of LioCyx-M004 and validates our strategic approach,” said Dr. Xiaoming Peng, CEO of Lion TCR. “Having demonstrated promising anti-tumor and antiviral activity in liver cancer, we are now well-positioned to evaluate its impact on the underlying viral infection that drives cancer development.”

LioCyx-M004 is an innovative autologous cell therapy engineered using mRNA to encode T-cell receptors that specifically target hepatitis B virus antigens. Preclinical and early clinical studies have shown the therapy’s ability to reduce viral antigen load and promote T-cell-mediated clearance of infected cells with a favorable safety profile to date.

Dr. Tina Wang, the company’s Chief Medical Officer, added that the ability to redirect their lead candidate from oncology to virology demonstrates the “remarkable versatility” of their platform. Lion TCR is also advancing an innovative in vivo TCR-T therapy, which, compared to traditional ex vivo T-cell therapies, offers advantages such as shorter production cycles, reduced costs, and enhanced accessibility for patients globally.