AusperBio Gets CDE Approval for Phase 3 Clinical Trial of Hepatitis B Drug AHB-137

AusperBio Phase 3 Clinical Trial Approved by CDE

Announcement

Ausperbio Therapeutics Inc. and Ausper Biopharma Co., Ltd (merged Ausperbio), a biotechnology company known for the advancement in oligonucleotide therapies for chronic hepatitis B (CHB) functional cure, received approval to perform a phase 3 clinical trial for its main candidate, AHB-137, from the China Center for Drug Evaluation (CDE). The phase 3 trial is a multicenter, randomized study in China to evaluate the safety and efficacy of its 24-week treatment with AHB-137 (300 mg) in HBeAg-negative patients of CHB receiving stable nucleos(t)ide analogue therapy. A liver disease, a chronic hepatitis B (CHB) infection, affects around 290 million people worldwide, also 75 million in China. It can cause other chronic severity like hepatocellular carcinoma and cirrhosis. Apart from the various available treatments, the functional cure is limited for patients. The CDE clearance is paving the way to new solutions in the global healthcare market.

AHB-137 Candidate

The AHB-137, a narrative antisense oligonucleotide, is under development for its potential functional cure confirmation for chronic hepatitis B (CHB). AHB-137 received a groundbreaking therapy designation in July 2024 from the China CDE for its potential to improve treatment outcomes for CHB patients in comparison to existing treatments. Further, the main data from the phase 2a study of AHB-1327 was presented in a past oral presentation at the Asia Pacific Association for the Study of the Liver (APASL) in March 2025. The end of treatment (EOT) results fetched from the phase 2b trial were showcased in a historic poster session at the European Association for the Study of the Liver (EASL) congress in May 2025, Amsterdam. AHB-137 is built using AusperBio’s investigational medicine and proprietary med-oligo ASO technology platform for the functional cure for chronic hepatitis B.

Views and Statements

Co-founder and CEO of AusperBio, Dr. Guofeng Cheng, said, “We are excited to receive approval from the CDE to perform phase 3 development of AHB-137. This clearance follows our groundbreaking designation last year shows our excellent safety and efficacy profile.  The profile defines our clinical data creation to date and revives our encouragement in AHB-137, proving the potential of the therapy for chronic hepatitis B.”

Co-founder and CSO, Chris Yang said, “We are thankful to the investigators, trial participants, Ausperbio’s colleagues, and clinical teams who have supported us to reach this valuable achievement. We plan to start this key trial soon with the motive of serving an innovative treatment option (alternative) to CHB patients."