SCG Cell Therapy Receives IND Clearance from China NMPA for SCG101V in Chronic Hepatitis B
Tuesday, July 08, 2025
SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing TCR T cell therapies for infectious diseases and related cancers, has received approval from the China National Medical Products Administration (NMPA) to begin clinical trials for SCG101V. This marks the first investigational cell therapy approved to enter a Phase 1/2 clinical trial targeting chronic hepatitis B virus (HBV) infection in China.
SCG101 is designed to address chronic hepatitis B by removing HBV cccDNA and HBV-DNA integrations from infected liver cells—key sources of ongoing infection and antigen production. These infected cells form a long-term viral reservoir that current antiviral treatments are unable to eliminate.
In earlier Phase 1 clinical studies involving patients with HBV-related hepatocellular carcinoma (HCC), SCG101 showed a favourable safety profile and promising signs of activity. Nearly all participants had been heavily pre-treated, with 94% previously receiving nucleoside analogue antiviral therapy, and 72% diagnosed with liver cirrhosis at the start of the trial. Following a single dose of SCG101, all patients experienced a rapid decrease in hepatitis B surface antigen (HBsAg) levels. A total of 94% of patients achieved a 1.0–4.6 log₁₀ reduction in HBsAg within 28 days, and levels remained below 100 IU/mL for up to one year without returning to baseline. In addition, 23% of patients achieved complete HBsAg loss, which is considered a key milestone toward a potential cure.
Chronic HBV infection currently affects an estimated 300 million people worldwide and is a major cause of liver cirrhosis and liver cancer, contributing to over 820,000 deaths annually. Although existing treatments can suppress the virus, they rarely lead to a functional cure, and therefore disease progression often continues.
The NMPA’s IND clearance supports SCG’s broader strategy to treat both virus-induced cancers and chronic infectious diseases. SCG101 is the first cell therapy candidate to receive approval to enter a Phase 1/2 clinical trial specifically for HBV and related cancers. The company now plans to begin a pivotal clinical study, building on the completion of its initial Phase 1 trial in HBV-related HCC. SCG expects to share additional clinical data as development progresses.
Source: prnewswire.com
