SCG Cell Therapy’s SCG101V Receives NMPA IND Clearance for Chronic Hepatitis B, First-Ever Cell Therapy for HBV

SINGAPORE – July 7, 2025 – SCG Cell Therapy Pte Ltd (SCG) today announced that the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for SCG101V. This marks a historic milestone as SCG101V becomes the first-ever investigational cell therapy approved to enter a Phase 1/2 clinical trial specifically for chronic hepatitis B virus (HBV) infection.

SCG101 is a pioneering TCR T cell therapy designed to fundamentally cure chronic hepatitis B by eliminating HBV covalently closed circular DNA (cccDNA) and integrated HBV-DNA within infected liver cells. These viral reservoirs are the root cause of persistent infection and antigen production, which current antiviral therapies, such as nucleoside analogues, largely fail to eradicate. The therapy is engineered to mimic the natural immune response observed in individuals who spontaneously clear HBV.

Compelling Phase 1 Clinical Data in HBV-related Liver Cancer (HCC): Prior clinical trials of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC) demonstrated a favorable safety profile and remarkable efficacy:

• Rapid HBsAg Decline: Following a single infusion, all patients experienced a rapid decline in serum hepatitis B surface antigen (HBsAg) levels.
• Significant HBsAg Reduction: Notably, 94% of patients achieved a 1.0–4.6 log₁₀ reduction in HBsAg within 28 days, with levels remaining suppressed for up to one year.
• Functional Cure Benchmark: Crucially, 23% of patients achieved complete HBsAg loss, a key indicator of a functional cure for HBV.
• These results were observed even in heavily pre-treated patients, with most having previous nucleoside analogue antiviral therapy and over 70% presenting with baseline liver cirrhosis.

Professor Niu Jinqi of The First Hospital of Jilin University lauded SCG101’s breakthrough potential, stating this IND approval is a pioneering step toward a functional cure for chronic hepatitis B, a global health crisis affecting an estimated 300 million people and causing over 820,000 deaths annually.

Christy Ma, CEO of SCG Cell Therapy, emphasized the historic nature of this IND clearance, expanding the company’s strategy from virus-induced cancers to chronic infectious diseases. SCG remains on track for initiating a pivotal study following the recent completion of its Phase 1 HBV-HCC study.

SCG101, powered by SCG’s proprietary GianTCR™ screening platform, targets a specific epitope of HBsAg, driving precise immune-mediated clearance of infected cells and eradication of HBV cccDNA.