July 2025 Beijing, China:
AusperBio Therapeutics Inc. and Ausper Biopharma Co., Ltd. (collectively known as AusperBio) have received the green light from China’s Center for Drug Evaluation (CDE) to initiate a Phase 3 clinical trial for their leading drug candidate, AHB-137, aimed at delivering a functional cure for chronic hepatitis B (CHB).
This milestone marks a significant advancement in the fight against CHB, a liver disease that affects more than 290 million people globally, including 75 million in China alone. Despite existing antiviral treatments, true functional cures remain rare, making AHB-137 a potential game-changer in global healthcare.
Inside the Phase 3 Trial: A New Chapter in Hepatitis B Research
The Phase 3 trial will be a multicenter, randomized study conducted across sites in China. It aims to evaluate the safety and efficacy of AHB-137 (300 mg) over a 24-week period in HBeAg-negative CHB patients who are already receiving stable nucleos(t)ide analogue therapy.
With this approval, AusperBio is one step closer to offering a transformative treatment that could drastically improve the quality of life for millions of chronic hepatitis B sufferers.
What Is AHB-137 and Why Does It Matter?
AHB-137 is a novel antisense oligonucleotide (ASO) therapy designed using AusperBio’s proprietary Med-Oligo™ ASO technology platform. It is uniquely engineered to suppress viral proteins responsible for persistent infection, positioning it as a leading candidate for a functional cure.
Key milestones:
July 2024: Received Breakthrough Therapy Designation from China’s CDE.
March 2025: Phase 2a data presented at APASL 2025 (Asia Pacific Association for the Study of the Liver).
May 2025: End-of-treatment data from Phase 2b trial showcased at EASL 2025 (European Association for the Study of the Liver Congress) in Amsterdam.
These clinical results demonstrated strong safety signals and promising antiviral efficacy, creating a foundation for Phase 3 expansion.
Leadership Speaks: Driving Toward a Functional Cure
Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, expressed optimism:
“This CDE clearance reinforces the potential of AHB-137 to become a first-in-class treatment for CHB. Our clinical results so far underscore its safety and efficacy, and we’re excited to take this major step toward bringing new hope to millions.”
Chris Yang, Co-founder and Chief Scientific Officer, added:
“We are deeply grateful to our research partners, patients, and clinical teams who made this progress possible. We are fully committed to starting this pivotal trial and redefining the future of hepatitis B care.”
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