AusperBio gets China CDE clearance to initiate phase III clinical trial of AHB-137 for chronic hepatitis B

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively known as AusperBio), a clinical-stage biotechnology company focused on targeted oligonucleotide therapies, announced 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 trial marks a major step in AusperBio’s mission to deliver a functional cure for chronic hepatitis B (CHB), a disease that affects millions worldwide and continues to pose long-term liver health risks despite current antiviral therapies.

Trial Design and Patient Focus

The phase III trial will be a randomized, double-blind, multicenter study conducted in China. It is designed to evaluate the efficacy and safety of 24 weeks of treatment with AHB-137 at a 300 mg dose.

Key details of the study:

• Target population: HBeAg-negative CHB patients
• Patients must be on stable nucleos(t)ide analogue therapy
• Primary objective: Assess functional cure potential of AHB-137 in this population

The Need for Functional Cure in Hepatitis B

Chronic hepatitis B infection affects an estimated 290 million people globally. Of these, approximately 75 million are in China alone. While current treatments can suppress viral replication and slow disease progression, they rarely deliver a true functional cure.

Untreated or uncontrolled CHB can lead to:

• Liver cirrhosis
• Hepatocellular carcinoma (HCC)
• Long-term liver damage and reduced quality of life

AHB-137 represents a novel therapeutic approach designed to achieve a functional cure—a sustained loss of hepatitis B surface antigen (HBsAg) after treatment completion.

AHB-137: Advancing on Multiple Clinical Fronts

AHB-137 is an unconjugated antisense oligonucleotide (ASO) designed using AusperBio’s proprietary Med-Oligo ASO platform. It works via a dual mechanism targeting the HBV life cycle and immune restoration.

The drug has shown promise throughout its clinical development:

• Completed global phase I trial
• Currently in multiple phase II studies in China
• Demonstrated consistent preclinical and clinical efficacy

Global Recognition and Breakthrough Status

AHB-137 has attracted international attention due to its potential as a transformative HBV therapy. Key milestones include:

• July 2024: Received Breakthrough Therapy Designation from China CDE
• March 2025: Phase IIa data presented in a late-breaker oral session at APASL
• May 2025: Phase IIb end-of-treatment data featured at EASL Congress in Amsterdam

These designations and presentations affirm the global scientific community’s interest in AHB-137 as a candidate capable of redefining HBV treatment outcomes.

Leadership Commentary on the Phase III Approval

AusperBio leadership emphasized the importance of this milestone for the company and the broader hepatitis B community.

Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, stated:

“We are thrilled to receive clearance from the China CDE to launch phase III development of AHB-137. This approval, following the 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.”

Dr. Chris Yang, Co-founder and Chief Scientific Officer, added:

“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. We intend to begin this crucial trial soon, with the goal of providing a transformative treatment option to CHB patients.”

Looking Ahead: Global Strategy and Development

The phase III trial approval in China signals AusperBio’s intention to move quickly toward broader regulatory and commercial milestones.

• The company plans to leverage the results from this trial as part of a clear global development strategy.
• AHB-137 has been featured at leading international liver disease conferences including EASL (2023, 2024, 2025), AASLD (2024), and APASL (2025).
• The drug’s progression through phase I and II trials supports its positioning as a next-generation treatment for HBV.

About AusperBio

AusperBio is a clinical-stage biopharmaceutical company with operations in the United States and China. It is dedicated to the development of oligonucleotide-based therapies and targeted delivery platforms, with an initial focus on achieving a functional cure for chronic hepatitis B infection.

The company’s Med-Oligo ASO technology underpins the development of AHB-137 and future candidates aimed at transforming how chronic viral infections are treated.

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