AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company advancing targeted oligonucleotide therapies for chronic hepatitis B (CHB) functional cure, today announced that the China 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 randomized, double-blind, multicenter 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.

Chronic Hepatitis B (CHB) infection is a liver disease affecting an estimated 290 million people globally, including approximately 75 million in China, and can cause other chronic complications such as cirrhosis and hepatocellular carcinoma. Despite available treatments that can suppress viral replication, a functional cure remains rare for most patients.

AHB-137 is a novel antisense oligonucleotide under development as a potential functional cure for chronic hepatitis B (CHB). In July 2024, it received Breakthrough Therapy Designation from the China CDE, recognizing 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.

"We are thrilled to receive clearance from the China CDE to launch Phase III development of AHB-137." said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. "This approval, following Breakthrough Designation granted last year, reflects the promising efficacy and safety profile of our clinical data generated to date and reinforces our confidence in AHB-137 as a potential cornerstone therapy for chronic hepatitis B. It is an exciting milestone for AusperBio and HBV functional cure therapy development."

"We would like to extend our sincere gratitude to the investigators, clinical teams, trial participants, and our dedicated AusperBio colleagues who have helped us reach this significant achievement." said Dr. Chris Yang, Co-founder and CSO. "We intend to begin this crucial trial soon, with the goal of providing a transformative treatment option to CHB patients."

This Phase III trial approval marks significant progress toward AusperBio's goal of developing science-based, patient-focused treatments aimed at achieving a functional cure for chronic hepatitis B on a global scale.

AHB-137, a novel unconjugated antisense oligonucleotide (ASO) designed using AusperBio's proprietary Med-Oligo™ ASO technology platform and an investigational medicine, is being developed to achieve a functional cure for chronic hepatitis B. Its clinical development has generated promising data, with key preclinical and clinical results presented at global leading conferences including EASL (2023, 2024, 2025), AASLD (2024), and APASL (2025). This novel dual-mechanism ASO has completed its global Phase 1 trial and is currently advancing through multiple Phase 2 studies in China. Supported by a clear global development strategy, AHB-137 is progressing rapidly toward delivering a potential cure for HBV.

Source: prnewswire.com