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December 22, 2025, AusperBio, a biotechnology company dedicated to achieving clinical cure for chronic hepatitis B through innovative targeted small nucleic acid drugs, announced itsPhase III AUSHINE Clinical Study (CTR20252792 / NCT07246889) of Targeted Antisense Oligonucleotide Drug ASO (Antisense Oligonucleotide) AHB-137Patient enrollment has been successfully completed.
AHB-137 is a novel unconjugated ASO drug developed by AusperBio based on its self-developed Med-Oligo™ antisense oligonucleotide technology platform. It is currently being studied as an investigational therapy aimed at achieving clinical cure for chronic hepatitis B. The drug features a triple mechanism of action and has demonstrated positive results in both preclinical and clinical trials, with related findings presented at prestigious international conferences such as EASL (2023-2025), AASLD (2024-2025), and APASL 2025. AHB-137 has completed Phase I clinical trials globally and is currently advancing multiple global Phase II clinical trials alongside Phase III clinical trials in China.AUSHINE Study is a randomized, double-blind, multi-center Phase III clinical trial designed to evaluate the efficacy and safety of AHB-137 Injection in HBeAg-negative patients with chronic hepatitis B who are receiving nucleos(t)ide analog therapy. The study has been conducted across multiple clinical centers in China, with recruitment completed ahead of schedule, enrolling over 570 patients.The principal investigator of this clinical trial, Professor Jian Sun, Dean of Nanfang Hospital, Southern Medical University, stated:"For the vast majority of HBeAg-negative patients with chronic hepatitis B undergoing long-term nucleos(t)ide analog treatment, current therapeutic options mainly achieve viral suppression and have yet to reach clinical cure. This large patient population, most of whom require lifelong medication and continuously face the risk of disease progression, still has an unmet significant medical need for clinical cure. The completion of enrollment in this pivotal Phase III study is an important milestone in filling this treatment gap. We look forward to this antisense oligonucleotide drug, with its triple mechanism of action, paving a new path to clinical cure for patients."Dr. Guozheng Cheng, Co-founder and CEO of AusperBio, stated"Completing the enrollment of over 570 patients in the Phase III clinical trial ahead of schedule marks a key milestone for AusperBio on the path to promoting a functional cure for chronic hepatitis B. It took only five months from receiving approval by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to complete the full patient enrollment, which fully demonstrates the high level of commitment and strong support from the investigators, patients, and clinical teams involved in this study. On behalf of AusperBio, I would like to take this opportunity to express our heartfelt gratitude to every participant for their dedication. We will always adhere to the principles of scientific rigor, accelerate the high-quality clinical development of AHB-137, and strive to bring a breakthrough new treatment option to patients with chronic hepatitis B as soon as possible."Dr. Yang Chengyong, Co-founder and CSO of AusperBio, stated"AUSHINE III Phase Study Completes Enrollment of All Patients Within 2025, Progress Exceeds Expectations: Sets Strong Foundation for Primary Endpoint Data by End of 2026. The rapid enrollment and active participation of clinical research institutions reflect the urgent need for innovative hepatitis B treatments among patients and highlight strong industry recognition of AHB-137's clinical potential. To date, AHB-137 has demonstrated promising clinical efficacy in multiple studies. Recent data presented at HEP-DART 2025 showed that 24 weeks of AHB-137 monotherapy achieved a 30% functional cure rate in patients with baseline HBsAg levels of 100-1,000 IU/mL. These findings further reinforce our confidence in AHB-137’s triple mechanism of action and its potential to achieve a functional cure for chronic hepatitis B."Source: AusperBio
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