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On July 22, 2025, AusperBio announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration had approved the initiation of Phase III clinical trials for its core candidate drug, AHB-137.AHB-137 is a non-conjugated compound with the potential to become a cornerstone for clinical cure of chronic hepatitis B.Antisense Oligonucleotide (ASO) Drugs, and has received widespread attention and recognition for its significantly outstanding efficacy and safety.Chronic Hepatitis B (CHB) is a major global public health issue, with approximately 290 million infected individuals worldwide, including about 75 million in China, and can subsequently lead to severe complications such as liver cirrhosis and hepatocellular carcinoma. Although existing therapies can suppress viral replication, the vast majority of patients still struggle to achieve clinical cure.This Phase III clinical trial is a randomized, double-blind, multicenter study conducted in China, aiming to evaluate the efficacy and safety of AHB-137 at a dose of 300 mg over a 24-week treatment period in HBeAg-negative patients with chronic hepatitis B who are receiving stable nucleos(t)ide analog therapy.AHB-137 Approved by China CDE,Included in the Breakthrough Therapy Category；
AHB-137 Clinical Phase IIa Treatment Data Study Results Selected for the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)™) and inLatest Breakthrough Results Oral ReportPublish;
AHB-137 Phase IIa Clinical Trial Key Data Results Selected for Asian Pacific Association for the Study of the Liver (APASL)™) and inLatest Breakthrough Results Oral ReportRelease;
AHB-137 Phase IIb Clinical Trial End-of-Treatment Data Selected for European Association for the Study of the Liver (EASL™) Annual MeetingBreakthrough Poster FormatPublish the results.
The approval of this Phase III clinical trial is a crucial step for AusperBio towards achieving the goal of clinical cure for chronic hepatitis B. A research and development path based on science and centered on patients not only drives a paradigm shift in hepatitis B treatment from "control" to "cure," but also injects innovative momentum into the global drug development field.Dr. Guozheng Cheng, Co-founder and CEO of AusperBio, stated"The approval by China CDE for AHB-137 to officially launch the Phase III clinical trial has greatly inspired us. Following the Breakthrough Therapy Designation received last year, this approval once again strongly validates the remarkable efficacy and safety demonstrated by AHB-137 in previous clinical studies, further reinforcing our confidence in AHB-137 as a cornerstone drug for the functional cure of chronic hepatitis B. This marks not only a significant milestone in AusperBio's development but also a landmark advancement in the field of hepatitis B virus (HBV) functional cure."Dr. Yang Chengyong, Co-founder and CSO of AusperBio, stated"AusperBio's achievement of this significant milestone is inseparable from the selfless dedication of researchers, clinical teams, trial participants, and our hardworking colleagues. We sincerely thank them. We will initiate this pivotal clinical trial as soon as possible to bring transformative treatment options to patients with chronic hepatitis B worldwide at the earliest opportunity."
