SCG Biopharma Advances First-in-Class TCR-T Therapy SCG101V for Chronic Hepatitis B with Potential Single-Dose Functional Cure

Hepatitis B virus is widely recognized as the "main culprit" behind liver cancer and decompensated liver function. Long-term infection can lead to a fatal progression: chronic hepatitis → cirrhosis → liver cancer/liver failure. There remains a significant gap between current treatment options and the internationally recognized goal of "functional cure" (clearance of hepatitis B surface antigen with sustained undetectable viral DNA). This week, there are...3Hepatitis B Therapy Receives IND Progress.

SCG SCIENCE (DALIAN) CO., LTD: Single Dose Administration, HBsAg Negative Conversion in 28 Days

SCG101-V Autologous T Cell Injection from SCG Science Approved for Clinical Trials, Aiming to Treat Chronic Hepatitis B. According to the company's press release, SCG101V isThe World's FirstThe TCR-T for chronic hepatitis B approved for clinical trials is mediated by specific TCR, selectively recognizing and targeting hepatocytes infected with the hepatitis B virus (HBV) through multiple mechanisms.FundamentallyClearing pathogenic covalently closed circular DNA (cccDNA) and establishing protective immune memory is expectedSingle-dose administration achieves hepatitis B cure。

According to the official press release, data presented at the 2025 European Association for the Study of the Liver (EASL) Annual Meeting showed that, following a single infusion of SCG101, patients exhibited...94%The patients showed a reduction of 1.0-4.6 log10 within 28 days, and during the follow-up period of up to one year, their HBsAg levels remained consistently below 100 IU/mL without rebound. Among them, 23.5% of the patients, after receiving treatment,21 DaysImplementation withinHBsAgCompletely cleared, and for up to1Remained clear throughout the year of follow-up.

Hepa Thera: Only 2 Injections Needed for HBsAg to Turn Negative

Hepa Thera's HT-101 Injection is proposed to be included in the breakthrough therapy category for the treatment of chronic hepatitis B virus infection. According to public information, HT-101 isThe FirstA domestically produced anti-hepatitis B siRNA new drug entering clinical stages, conjugated with GalNAc, exerts its therapeutic effect by interfering with HBV mRNA, disrupting its function as a post-transcriptional translation template, and preventing the synthesis of related viral proteins, thereby inhibiting the formation of hepatitis B virus particles.

Phase 1b clinical study presented at the 2024 EASL Annual Meeting showed that all participants in the HT-101 treatment group maintained a good reduction in HBsAg levels at 48 weeks during the extension period. Notably, in the 400 mg dose group, one participant achieved this after receiving two doses.48 WeeksFollow-up to achieve HBsAg clearance.

Argo: 56% of Patients Achieved HBsAg Loss

Argo's BW-20507 Approved for Clinical Trials, Intended for Development in Chronic Hepatitis B Virus Infection. BW-20507 is an siRNA targeting the S region of HBV messenger RNA and has been designated as a breakthrough therapy by the CDE for the treatment of chronic hepatitis B. Phase 1/2a clinical trial results presented at the 2025 European Association for the Study of the Liver (EASL) Annual Meeting showed that BW-20507 was administered via subcutaneous injection., once every four weeks, for a total of three doses, which can significantly reduce HBsAg levels in a dose-dependent manner, with the maximum reduction of 2.9~3.2 log₁₀ IU/mL observed in the 200 mg and 400 mg dose groups.

Source: Yima Guest

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