AusperBio announced on 22 July that China's Centre for Drug Evaluation (CDE) approved Phase III trials for its antisense oligonucleotide (ASO) drug AHB-137, targeting functional cure in HBeAg-negative chronic hepatitis B (CHB) patients. The randomised double-blind study will evaluate 300 mg doses over 24 weeks in patients on stable nucleos(t)ide analogue therapy. AHB-137 previously received breakthrough therapy designation (BTD) in 2024 and demonstrated strong efficacy in Phase II trials.

CHB affects 290 million globally, including 75 million in China, often leading to cirrhosis and liver cancer. AHB-137, developed using AusperBio's proprietary Med-Oligo platform, represents a potential first-in-class non-conjugated ASO therapy. CEO Guofeng Cheng noted the trial approval marks a milestone toward achieving HBV functional cure, while CSO Chengyong Yang highlighted plans for rapid trial initiation to address unmet needs.

According to PharmCube's NextBiopharm® database, there are 200 CHB therapies in the global pipeline, including 7 ASOs. Click here to request a free trial for NextBiopharm®.