AusperBio's Breakthrough Hepatitis B Drug AHB-137 Granted Approval to Initiate Phase 3 Clinical Trial in China with Potential for Functional Cure

On July 22, AusperBio(Ausper Biopharma Co., Ltd. and AusperBio Therapeutics Inc.)Announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration has approved the initiation of Phase 3 clinical trials for its core candidate drug, AHB-137.AHB-137 is a non-conjugated antisense oligonucleotide (ASO) drug with the potential to become a cornerstone for clinical cure of chronic hepatitis B.This Phase 3 clinical trial is a randomized, double-blind, multicenter study conducted in China, aimed at evaluating the efficacy of AHB-137 at a dose of 300mg over a 24-week treatment period.HBeAg-negative chronic hepatitis B patients receiving stable nucleos(t)ide analog therapyEfficacy and Safety in China.

AusperBio is a clinical-stage innovative drug research and development company focused on developing self-innovative targeted delivery small nucleic acid drugs, committed to achieving the goal of clinical cure for chronic hepatitis B.Chronic Hepatitis B (CHB) is a major global public health issue that can lead to serious complications such as liver cirrhosis and hepatocellular carcinoma. Although existing therapies can suppress viral replication, the vast majority of patients still struggle to achieve clinical cure.

According to the press release from AusperBio, the preclinical and clinical data of AHB-137 have gained significant attention at the International Liver Congress™ (EASL™ 2023, 2024, 2025) and The Liver Meeting® (AASLD™) in 2024. Currently, AHB-137 is simultaneously undergoing a multinational multi-center Phase 1 clinical trial and several Phase 2 clinical trials being conducted in China.The product has been designated as a breakthrough therapy by the CDE for the indication of chronic hepatitis B.

In May 2025, AusperBio announced the End of Treatment (EOT) data from the Phase 2b clinical trial of AHB-137 conducted in China. This report highlights the interim data from the multicenter, randomized Phase 2b clinical study of AHB-137, which evaluated the efficacy and safety of AHB-137 in HBeAg-negative patients with chronic hepatitis B who are receiving nucleos(t)ide analog (NA) therapy.

In the study, participants were randomly assigned to the AHB-137 300 mg 24-week treatment group and the 16-week treatment group. The primary endpoints of the study were the level of hepatitis B surface antigen (HBsAg) below the lower limit of quantification (<0.05 IU/mL) and the level of hepatitis B virus (HBV) DNA below the lower limit of quantification (<10 IU/mL) at the end of the treatment period.

In the 24-week treatment group, 75% (24/32) of the subjects reached this primary endpoint; in the 16-week treatment group, 66% (21/32) of the subjects reached this primary endpoint.. Among the subjects who reached the primary endpoint,More than 80% of subjects achieved HBsAg clearance within 12 weeks of treatment., and at the end of the treatment,At week 24 and week 16, seroconversion of hepatitis B surface antibody (anti-HBs) was observed in 54% and 33% of participants, respectively.AHB-137 demonstrated good tolerability and effective safety in both treatment groups.

According to a previous press release by AusperBio, the rapid decline in HBsAg and the higher seroconversion rate of hepatitis B surface antibodies achieved during the AHB-137 treatment process have greatly encouraged researchers. AHB-137 demonstrated exciting efficacy data and favorable safety data in the Phase 2b clinical trial, further confirming the excellent clinical efficacy observed in the Phase 2a trial.The approval of this Phase 3 clinical trial is a crucial step for AusperBio towards achieving the goal of clinical cure for chronic hepatitis B.

[1]AusperBio's Oligonucleotide Drug AHB-137 Approved by China's National Medical Products Administration (CDE) for Phase III Clinical Trials. From https://mp.weixin.qq.com/s/6sqPhpsaKO1wbFIx8d98xA