By Fineline Cube 
China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has approved SCG Cell Therapy Pte. Ltd, a Singapore-based company with an office in Shanghai, to conduct a Phase I/II study for its SCG101V. This HBV-specific TCR-engineered T cell therapy is the world’s first of its kind to receive approval for study in chronic hepatitis B virus (HBV) infection.
Mechanism of Action
Developed using SCG’s proprietary GianTCR platform, SCG101V utilizes HBV-specific T cell receptors to selectively identify and target HBV-infected hepatocytes. The therapy works through multiple mechanisms to eliminate covalently closed circular DNA (cccDNA), eradicate viral reservoirs and integrated fragments, and establish protective immune memory. This approach aims to completely remove viral reservoirs, potentially offering a path to a functional cure with no viral rebound.
Clinical Data and Efficacy
The approval follows SCG’s recent presentation at EASL 2025, where updated clinical data from its Late-Breaker session demonstrated dual antiviral and antitumor efficacy in HBV-related hepatocellular carcinoma patients. Specifically, 94% of patients achieved a 1.0-4.6 log10 reduction in HBsAg within 28 days, and 23.5% attained complete HBsAg clearance within 21 days, with sustained results for 1 year without rebound.-Fineline Info & Tech