Xingyao Kunze Initiates Phase II Clinical Trial of HT-101 Injection for Chronic Hepatitis B Virus Infection

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Suzhou Hepa Thera Biotech Co., Ltd.'s HT-101 Injection combined with HT-102 Injection has initiated a multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate its efficacy and safety in patients with chronic hepatitis B. The clinical trial registration number is CTR20254071, and the initial information disclosure date was October 13, 2025.

The drug formulation is an injectable, administered subcutaneously. The dosage follows the clinical protocol: HT-101 Injection and HT-102 Injection are administered once every 4 weeks for a total of 7 doses; the placebo is administered once every 4 weeks for a total of 2 doses. The purpose of this trial is to explore the efficacy of different treatment durations of HT-101 Injection combined with HT-102 Injection in patients with chronic hepatitis B.

HT-101 Injection is a chemical drug indicated for chronic hepatitis B virus infection. Chronic hepatitis B is a chronic inflammatory liver disease caused by persistent hepatitis B virus infection for more than 6 months. Most patients have no obvious symptoms, while some may experience fatigue, dizziness, and loss of appetite, and it is diagnosed through tests such as the five hepatitis B markers and HBV DNA.

The primary endpoint of this trial includes the proportion of participants achieving functional cure (defined as clearance of serum hepatitis B surface antigen and undetectable serum hepatitis B virus deoxyribonucleic acid) at Week 60; secondary endpoints include HBsAg clearance rate, the proportion of participants achieving functional cure, and multiple other indicators.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 60 participants.

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Editor: Xiaolang Express