On 7 July, Singapore's SCG Cell Therapy announced that China's National Medical Products Administration (NMPA) Centre for Drug Evaluation (CDE) approved its investigational new drug (IND) application for SCG101V, a hepatitis B virus (HBV)-specific T-cell receptor (TCR) engineered T-cell therapy, for Phase I/II clinical trials in chronic hepatitis B. HBV is a leading cause of hepatocellular carcinoma and liver failure, with current treatments falling short of functional cure goals. SCG101V leverages naturally occurring TCRs to selectively target HBV-infected cells, eliminating covalently closed circular DNA (cccDNA) and viral reservoirs while establishing protective immune memory.

At the 2025 European Association for the Study of the Liver (EASL) congress, SCG presented late-breaker data showing SCG101, a related TCR-T therapy, induced rapid HBsAg decline in 94% of advanced HBV-related hepatocellular carcinoma patients, with 23.5% achieving sustained HBsAg clearance for over one year. SCG101V demonstrates potential as a single-dose functional cure by simultaneously eradicating cccDNA and HBsAg.

Source:
https://mp.weixin.qq.com/s?__biz=MzUxMTY5MzM5OQ==&mid=2247578486&idx=3&sn=ecb40a79a15e0f33dc7f6848f6b85c95