World's First Cell Therapy for Chronic Hepatitis B, SCG101, Granted IND Approval for Clinical Trials

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Recently, according to the information on the CDE official website, SCG SCIENCE (DALIAN) CO., LTD.(hereinafter referred to as "SCG")The I/II phase clinical trial application for the self-developed SCG101 autologous T-cell injection has been tacitly approved by the CDE, with the indication being chronic hepatitis B.

This is the world's first cell therapy product for chronic hepatitis B.It is reported that SCG101 is an investigational autologousChimeric T-cell Receptor T Cells（TCR-T）Therapy, aimed at selectively targeting hepatitis B surface antigen（HBsAg）Specific epitopes. Preclinical and clinical studies have shown that SCG101 eliminates infected cells and malignant cells through precise immune-mediated mechanisms, demonstrating significant tumor suppression effects and effectively eliminatingHepatitis BVirus（HBV）Covalently Closed Circular DNA（cccDNA）。

HBVRecognized as the "main culprit" of liver cancer and decompensated liver function, long-term infection can lead to the fatal progression of chronic hepatitis → cirrhosis → liver cancer/liver failure.To date, HBV remains a significant health burden, affecting more than 250 million people worldwide. It is the leading cause of liver cancer, accounting for 50%-80% of global hepatocellular carcinoma cases. Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and oncogene activation, thereby promoting the development of hepatocellular carcinoma.

SCG101The significant importance lies in,On the one handItsPerhapsCanBreakthrough Existing Drugs(such as nucleotide analogs, interferons, siRNA, etc.)Can only inhibit viral replication but cannot completely eliminate cccDNA(Key Template for Hepatitis B Virus Replication)The limitations, offer hope for a functional cure for patients with chronic hepatitis B!On the other hand，SCG101PossibleHasDual Antiviral and Antitumor Effects，There isAchieve"Kill two birds with one stone"TreatmentAdvancedHBVInfectionLiver CancerPatientThePotential。

In May 2025, at the European Association for the Study of the Liver（EASL）At the conference, SCG SCIENCE (DALIAN) CO., LTD announced the Phase I clinical data of SCG101 in patients with advanced HBV-related liver cancer. The results showed that SCG101Can makeSerum HBsAg and HBV-DNA were persistently cleared in a large number of previously treated HBV-related HCC patients.Specifically,，InAcceptAfter a single dose of SCG101 infusion, all patientsTheSerum HBsAg decreased rapidly, 94%（16/17）OfPatientA reduction of 1.0-4.6 log₁₀ was achieved within 28 days, and levels remained <100 IU/mL for up to 1 year. Notably, in 4 patients...（23.5%）Achieved HBsAg disappearance.NotableA LittleYes,ThisItemIPeriodClinicalResearchTheEnrollmentPatientTheConditionAverageRatherSevere。Among which，94% of patients had previously received nucleoside analog antiviral therapy, and 72% of patients had cirrhosis at baseline.

At the same time，In addition to its antiviral effects, SCG101 has also demonstrated encouraging antitumor activity. All patients had previously received at least two lines of systemic cancer therapy, including immune checkpoint inhibitors. Despite the heavily pretreated population,In17NamePatientChina，Still8 names（47%）PatientShow measurable tumor regression.AndIn dataStatisticsAs of the cutoff date, the median overall survival has not been reached.（OS）。

This CDE ApprovalThe clinical trial application of SCG101 marksNew Breakthrough Achieved in the Exploration of Clinical Cure for Hepatitis B.Looking forward to the successful progress of the SCG101 project, bringing better treatment options for hepatitis B patients and effectively reducing the risk of liver cancer!

References:

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2. CompanyOfficial Website

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