AusperBio Therapeutics Inc and Ausper Biopharma Co Ltd (collectively AusperBio), a China-based clinical-stage biotechnology company advancing targeted oligonucleotide therapies for chronic hepatitis B (CHB) functional cure, announced on Monday that China's Center for Drug Evaluation (CDE) has approved the initiation of a Phase III clinical trial for its lead candidate, AHB-137.

The Phase III trial is a randomised, double-blind, multicentre study in China evaluating the efficacy and safety of 24-week treatment with AHB-137 (300 mg) in HBeAg-negative CHB patients who are receiving stable nucleos(t)ide analogue therapy.

AHB-137 is a novel antisense oligonucleotide (ASO) under development as a potential functional cure for chronic hepatitis B. In July 2024, it received Breakthrough Therapy Designation from the China CDE, recognising its potential to significantly improve treatment outcomes for CHB patients compared to existing treatments. In March 2025, key data from the Phase IIa study were featured in a late-breaker oral presentation at the Asia-Pacific Association for the Study of the Liver (APASL) conference. In May 2025, the end of treatment (EOT) results from the Phase IIb trial were presented in a late-breaking poster session at the European Association for the Study of the Liver (EASL) Congress in Amsterdam.

Designed using AusperBio's proprietary Med-Oligo ASO technology platform, AHB-137 is being developed to achieve a functional cure for chronic hepatitis B.