China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s SCG101 autologous T cell therapy has obtained tacit clinical trial approval in China. This marks a world-first clinical indication for the treatment of cholangiocarcinoma.
SCG101’s Expanding Clinical Indications
SCG101, a TCR-T cell therapy, targets specific hepatitis B virus (HBV) epitopes and has previously received clinical trial approvals in the United States, Singapore, and Hong Kong for the treatment of HBV-related hepatocellular carcinoma (HCC) from 2022 to 2023. The latest tacit approval expands SCG101’s clinical scope to include HBV-related intrahepatic cholangiocarcinoma (ICC).
Significance of SCG101 for Intrahepatic Cholangiocarcinoma
Intrahepatic cholangiocarcinoma (ICC) is a highly malignant cancer with a hidden onset and a lack of effective treatment methods. Its incidence rate has been increasing, particularly in Asian countries, with Chinese patients comprising 55% of global cases. Over 50% of ICC cases are associated with HBV infection. Clinical research on SCG101 has shown significant antiviral and anti-tumor activity in the treatment of advanced HBV-related HCC patients, significantly prolonging the progression-free survival period.
SCG Cell Therapy’s Focus on Immunotherapies
Singapore-based SCG Cell Therapy Pte. Ltd specializes in the development of novel immunotherapies targeting common carcinogenic infections, including human papillomavirus (HPV), HBV, and human herpesvirus (EBV).- Flcube.com
