SCG Cell Therapy Announces CDE Approval of SCG101V for Phase 1/2 Clinical Trial in Chronic Hepatitis B

July 7，SCG (Star River Biotechnology) announced, in ChinaCenter for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approved itsHBV (Hepatitis B Virus) Specific TCR (T Cell Receptor) Engineered T Cell Therapy——SCG101V New Drug Phase 1/2 Clinical Trial (IND) Application for the Treatment of Chronic Hepatitis B.

Hepatitis B virus is widely recognized as the "main culprit" of liver cancer and decompensated liver function. Long-term infection can lead to a fatal progression: chronic hepatitis → liver cirrhosis → liver cancer/liver failure. The replication of the hepatitis B virus"Root"——Covalently Closed CircularDNA（cccDNA）Implantable in the human bodyDNA, disrupting proto-oncogenes, tumor suppressor genes, and genomic stability, leading to uncontrolled proliferation of hepatocytes and directly inducing carcinogenesis.Even after long-term treatment, there remains a significant gap between existing therapeutic options and the internationally recognized goal of "functional cure" (clearance of hepatitis B surface antigen with sustained undetectability of viral DNA).

Medical research shows that the specific immune response mediated by T-cell receptors (TCR) naturally present in healthy adults is a key mechanism for clearing HBV infection. Based on this scientific insight, SCG SCIENCE (DALIAN) CO., LTD has screened high-affinity, high-activity natural TCRs specifically targeting hepatitis B surface antigen and remodeled patients' immune systems through T-cell engineering. This led to the development of their innovative cell therapy pipeline, SCG101V, for chronic hepatitis B.SCG101VBy specificityTCRMediation, Selective Recognition, and Targeted InfectionHBVHepatocytes, through multiple mechanisms, eliminatecccDNAAnd eliminate viral reservoirs and integrated fragments, and establish protective immune memory. Once the viral reservoirs are completely eliminated,HBVThere is no way to rebound.

Clinical data shows that SCG101V exhibits"One Shot Cure"The Therapeutic Potential: A single administration can simultaneously eradicate HBV cccDNA and HBsAg, holding promise as a functional cure for chronic hepatitis B.

On May 8, 2025, at the 2025 European Association for the Study of the Liver (EASL2025) Annual Meeting in Amsterdam, Netherlands, SCG101, the HBV-specific TCR-T cell therapy developed by SCG SCIENCE (DALIAN) CO., LTD, was once again featured in the latest breakthrough (Late-breaker) clinical research. The latest data from this clinical trial shows that SCG101 demonstratesDual Antiviral and Antitumor EffectsAccording to the disclosed information, all patients who received a single infusion of SCG101 experienced a rapid and dramatic decline in serum hepatitis B surface antigen (HBsAg), with levels dropping significantly.94%of patients in28The decline reached within days1.0-4.6 log₁₀, and during the one-year follow-up period, the patientHBsAgContinuously maintained below100 IU/mLThe level has no rebound. It is worth special attention that, among them, there is23.5%Patients who received treatment21Achieve within daysHBsAgCompletely cleared, and for up to1Remained clear throughout the year of follow-up.

References:
[1] Farewell to Hepatitis B: SCG101V, the World’s First Cell Therapy Product for Chronic Hepatitis B, Approved for Clinical Trials. From https://www.prnasia.com/story/495600-1.shtml

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