Home AusperBio Announces Completion of Patient Enrollment in Phase III AUSHINE Trial of AHB-137 for Chronic Hepatitis B

AusperBio Announces Completion of Patient Enrollment in Phase III AUSHINE Trial of AHB-137 for Chronic Hepatitis B

Dec 23, 2025 11:45 CST Updated 11:45
AusperBio

Biological Vaccine and Nucleic Acid Drug Developer

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HANGZHOU, China and SAN FRANCISCO, USA – December 22, 2025 – AusperBio, a biotechnology company dedicated to achieving clinical cure for chronic hepatitis B through innovative targeted small nucleic acid drugs, announced today the successful completion of patient enrollment in the Phase III AUSHINE clinical trial (CTR20252792 / NCT07246889) for its targeted antisense oligonucleotide drug AHB-137 aimed at achieving clinical cure for chronic hepatitis B.
Yuansheng Venture Capital Continuously Participated in AusperBio's Series A, B, B+, and B2 Rounds of Financing in July 2024, December 2024, May 2025, and September 2025.
AUSHINE Study is a randomized, double-blind, multicenter 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.
Chronic hepatitis B remains a significant challenge in the global public health domain. According to the "Global Hepatitis Report" released by the World Health Organization (WHO) in 2024, approximately 254 million people worldwide are infected with the hepatitis B virus, with 1.2 million new infections occurring annually. In China alone, there are 75 million individuals living with chronic hepatitis B virus infection, and liver diseases caused by hepatitis B account for about 77% of cirrhosis cases and 84% of primary hepatocellular carcinoma cases.
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. In this large patient population, most individuals require lifelong medication and continue to face the risk of disease progression; achieving clinical cure remains a significant unmet medical need. The completion of enrollment in this pivotal Phase III study is an important milestone in addressing this treatment gap. We look forward to this antisense oligonucleotide drug, with its triple mechanism of action, paving a new path toward clinical cure for patients."
Dr. Guozheng Cheng, Co-founder and CEO of AusperBio, said"Completing the enrollment of over 570 patients in the Phase III clinical trial ahead of schedule is a key milestone for AusperBio on the path to promoting the clinical cure of chronic hepatitis B. From obtainingCenter for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of ChinaIt only took five months from the approval to commence Phase III clinical trials to the completion of patient enrollment, fully demonstrating the high level of commitment and full 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 my heartfelt gratitude to every participant for their dedication.We will always adhere to the principle of scientific rigor, accelerate the high-quality clinical development of AHB-137, and strive to bring it to patients as soon as possible.Chronic Hepatitis B"Patients bring breakthrough new treatment options."
Dr. Chengyong Yang, Co-founder and CSO of AusperBio, stated"AUSHINE Phase III study completes enrollment of all patients within 2025, this progress exceeds our expectations and lays a solid foundation for the project to obtain primary endpoint data by the end of 2026. The efficient enrollment and active participation of various clinical research institutions reflect the urgent need of patients for innovative hepatitis B treatments, as well as the industry's high recognition of the clinical potential of AHB-137. To date, AHB-137 has demonstrated positive clinical efficacy in multiple clinical studies. In the data recently presented at the HEP-DART 2025 conference, 24 weeks of AHB-137 monotherapy achieved a 30% clinical cure rate in patients with baseline HBsAg levels of 100-1,000 IU/mL. These data further strengthen our confidence in the triple mechanism of action of AHB-137 and its ability to achieveChronic Hepatitis B"Confidence in the potential for clinical cure."

About AHB-137



AHB-137 is a novel unconjugated ASO drug developed by AusperBio based on its self-developed Med-Oligo™ antisense oligonucleotide technology platform. Currently as an investigational therapy, it aims to achieve clinical cure for chronic hepatitis B. The drug features a triple mechanism of action and has demonstrated positive results in preclinical and clinical trials, with related findings presented at internationally authoritative conferences such as EASL (2023-2025), AASLD (2024-2025), and APASL 2025. AHB-137 has completed global Phase I clinical trials and is currently advancing multiple global Phase II clinical trials alongside Phase III clinical trials in China.


About AusperBio



AusperBioAusperBio is a clinical-stage innovative drug research and development company operating simultaneously in China and the United States, dedicated to developing First-in-class and Best-in-class self-innovative targeted delivery small nucleic acid drugs. AusperBio owns the proprietary intellectual property Med-Oligo™ ASO patent technology platform, focusing on functional cures for chronic hepatitis B (HBV) and highly efficient targeted treatments for liver diseases, while expanding into targeted small nucleic acid therapies for new targets beyond the liver. AusperBio's strategy is to combine its world-leading Med-Oligo™ oligonucleotide technology with specific and highly efficient targeting technologies to address a wide range of currently unmet medical needs.


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About YuanSheng Ventures



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Yuansheng Venture CapitalIt is an investment institution focused on the early and growth-stage healthcare sector, based in Suzhou BioBAY with a global reach. It has already invested in over 200 outstanding companies in the life sciences and health field, covering areas such as new drug development, medical devices, in vitro diagnostics, precision medicine, and more.Medical Future TechnologyIn four major directions, substantial investment returns have been achieved, with 20 enterprises already listed on capital markets such as the Hong Kong Stock Exchange and the Sci-Tech Innovation Board. YuanSheng Ventures has been repeatedly ranked among the Top 10 venture capital funds in China's healthcare sector and recognized as one of the most active healthcare investment institutions in China. With a team of seasoned professional investors and a globally top-tier scientific advisory board, YuanSheng Ventures possesses extensive experience in entrepreneurship, venture capital, and corporate operations within the biopharmaceutical industry and beyond. Leveraging professionalism, dedication, and abundant industry resources, we are committed to becoming one of the most successful healthcare and pharmaceutical venture capital funds in China.

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