HT-102 / Suzhou Biomissile Pharmaceuticals, Suzhou HepaThera Biotech - LARVOL DELTA

High rate and sustained HBsAg loss achieved with HT-101 plus HT-102 combination therapy in HBeAg-negative, nucleos(t)ide analogue-suppressed patients: ongoing off-treatment results from a multicenter Ib/IIa study (EASL 2026) - P1/2 | "Combination therapy with HT-101 and HT-102 achieved very high rate of HBsAg loss which was sustained for 8 weeks post-treatment. HT-101 monotherapy demonstrated durable HBsAg loss for up to 24 weeks post-treatment. These results support the continued development of HT-101 and HT-102 as a promising strategy for achieving functional cure in patients with chronic HBV infection."

Clinical • Combination therapy • Late-breaking abstract • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Combination therapy with HT-101 and HT-102 achieves rapid and progressive HBsAg loss in HBeAg-negative, nucleos(t)ide analogues-suppressed patients: 24-week results from an ongoing multicentre, open-label phase Ib/IIa study (APASL 2026) - No abstract available

Clinical • Combination therapy • P1/2 data

A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Suzhou HepaThera Biotech Co., Ltd.

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1/2 | N=86 | Active, not recruiting | Sponsor: Suzhou HepaThera Biotech Co., Ltd.

New P1/2 trial • Hepatitis B • Infectious Disease • Inflammation

Clinical Trials of the Hepatitis B Sandwich Combination Therapy for Treating Patients Infected With Hepatitis B Virus (clinicaltrials.gov) - P=N/A | N=12 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New trial • Hepatitis B • Hepatocellular Cancer • Infectious Disease • Inflammation • Oncology • Solid Tumor

Inhibition of HBV Replication by a Fully Humanized Neutralizing Antibody In Vivo and In Vitro. (PubMed, Acta Naturae) - "Furthermore, HT-102 exhibited no ADCC effect but displayed a weak CDC effect along with a dose-dependent response...Finally, a mild immune response was induced, while reducing the burden of antigen-antibody complexes circulating within the system. Consequently, strain on the patient's immune system was alleviated by effectively slowing down CD8+T lymphocyte depletion, and functional cure was ultimately achieved as intended."

Journal • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • CD8

Rapid hepatitis B surface antigen reduction: results from a phase Ⅰb study evaluating multiple ascending doses of HT-102, a neutralizing antibody against HBsAg in chronic hepatitis B patients (APASL 2025) - P1 | "Multiple doses of HT-102 in 50-300mg were associated with rapid HBsAg reductions in the HBV-infected patients and slight greater HBsAg decline with longer sustained duration was observed in 150mg or 300mg group. HT-102 is generally well tolerated in HBV-infected patients with NRTI with good pharmacokinetics profile. The early data support further evaluation of HT-102 as a potential functional cure for patients with chronic HBV infection."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation