AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that China’s Center for Drug Evaluation (CDE) has approved their lead candidate, AHB-137, to proceed into a Phase III clinical trial for chronic hepatitis B (CHB). This pivotal study will be a randomized, double-blind, multicenter trial evaluating the safety and efficacy of 24 weeks of AHB-137 treatment in HBeAg-negative CHB patients currently on stable nucleos(t)ide analogue therapy.
Chronic hepatitis B affects approximately 290 million people worldwide, with around 75 million in China alone. The infection can lead to severe liver complications such as cirrhosis and hepatocellular carcinoma. While existing therapies suppress viral replication, a functional cure remains elusive for most patients.
AHB-137, a novel antisense oligonucleotide, aims to address this gap. It was granted Breakthrough Therapy Designation by China’s CDE in July 2024, reflecting its potential to significantly improve treatment outcomes. Promising Phase IIa and IIb data were presented at leading liver disease conferences in early 2025, demonstrating the drug’s efficacy and safety profile.
Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed enthusiasm about the clearance, calling it an exciting milestone that strengthens confidence in AHB-137 as a potential cornerstone therapy for CHB. Dr. Chris Yang, Co-founder and CSO, thanked the clinical teams and participants and confirmed plans to begin the Phase III trial soon.
This approval marks a critical step in AusperBio’s mission to develop patient-focused, science-driven therapies aimed at achieving a functional cure for chronic hepatitis B globally.