AusperBio Completes Patient Enrollment in Phase III AUSHINE Study of AHB-137 for Chronic Hepatitis B

SAN FRANCISCO, Dec. 22, 2025 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (together AusperBio), a clinical-stage biotechnology company developing targeted oligonucleotide therapies for functional cure of chronic hepatitis B (CHB), today announced the completion of patient enrollment in its Phase III AUSHINE clinical trial (CTR20252792/ NCT07246889).

The AUSHINE study is a randomized, double-blind, multicenter Phase III trial evaluating the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with nucleos(t)ide analogue (NA) therapy.

CHB remains a major global public health challenge. According to the World Health Organization (WHO) Global Hepatitis Report 2024, approximately 254 million people worldwide are living with hepatitis B virus (HBV), and 1.2 million people are newly infected annually with HBV. In China alone, an estimated 75 million are chronically infected¹.

Professor Jian Sun, principal investigator and President of Nanfang Hospital, Southern Medical University, commented, “For the vast majority of HBeAg-negative CHB patients receiving long-term nucleos(t)ide analogue therapy, treatment today is only suppressive rather than curative. Functional cure remains an urgent unmet goal for this large patient population, most of whom face lifelong therapy with ongoing risk of disease progression. The completion of enrollment in this pivotal Phase III study is a critically important step towards addressing this gap, and we are eager to see if the novel, triple-mechanistic approach of this ASO therapy can unlock a new path to functional cure for our patients.”

Dr. Guofeng Cheng, Co-founder and CEO of AusperBio, commented, “The successful enrollment of over 570 patients ahead of schedule marks a critical milestone in our mission to advance a functional cure for chronic hepatitis B. Full enrollment was achieved within five months of China CDE approval, reflecting the strong engagement and dedication of  the investigators, patients, clinical teams who partnered with us in this program. We are deeply grateful and remain firmly committed to advancing AHB-137 through a rigorous registrational pathway, guided by strong science and a clear focus on delivering a paradigm-shifting treatment for people living with chronic hepatitis B.”       

Dr. Chris Yang, Co-founder and CSO of AusperBio, added, “Completing enrollment of the Phase III AUSHINE study within 2025 exceeded our initial expectations and positions the program for rapid progression toward its primary endpoint readout. The pace of enrollment and strong interest from clinical sites reflect both the urgent needs for novel HBV treatment and the promising efficacy and safety profile of AHB-137. The encouraging clinical efficacy observed to date, including a functional cure rate of approximately 30% recently presented at the HEP-DART 2025 conference, reinforces our confidence in the triple-mechanistic activities of AHB-137 and its potential to deliver functional cure for CHB patients.”

About AHB-137

AHB-137 is a novel unconjugated antisense oligonucleotide (ASO) designed using AusperBio’s proprietary Med-Oligo ASO technology platform and is designed to achieve functional cure of CHB. Its mechanism integrates three complementary actions: targeted suppression of HBsAg at the transcriptional level, inhibition of viral DNA replication, and immune reactivation. AHB-137 has demonstrated promising preclinical and clinical results, with key findings presented at major international hepatology congresses including EASL (2023 – 2025), AASLD (2024 – 2025), and APASL (2025). AHB-137 has completed a global Phase I study and is currently being evaluated in multiple Phase II studies and a phase III trial in China. Supported by a coordinated global development strategy, AHB-137 is advancing toward its goal of delivering a potential functional cure for HBV infection.

About AusperBio

AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on achieving functional cure for CHB infection. The company has developed a proprietary Med-Oligo ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining efficient targeted delivery conjugation technologies, the modular Med-Oligo platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, muscle disorders, and immune diseases. For more information, visit www.ausperbio.com

Reference：

1、 Wang, X., Li, Y., & Zhang, H. (2024). Prevalence of chronic hepatitis B virus infection in China: A national cross-sectional study. The Lancet Regional Health – Western Pacific, 50, 101234. https://doi.org/10.1016/j.lanwpc.2024.101234

*This press release is prepared by AusperBio (the “Company”, “We”) for informational purposes only. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “anticipate”, “expect”, “intend”, “plan”, “believe”, “continue”, “could”, “potential”, “may”, “will”, “goal” or similar expressions and the negatives of those terms. However, not all forward-looking statements contain these identifying words.

These forward-looking statements involve substantial known and unknown risks and uncertainties, including the risk that results in earlier clinical studies may not be indicative of future results and that any product candidates may not ultimately obtain required approvals or meaningfully improve patient outcomes, and other factors that are beyond the Company’s control and are difficult to predict and may cause our actual results, timing of results, or achievements to be materially different from the information expressed or implied by these forward-looking statements. We anticipate that subsequent events and developments may cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

Except as expressly required by law, the Company and/or its officers, directors, employees, and agents shall not assume responsibility for the accuracy and completeness of the forward-looking statements in the information provided.

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SOURCE AusperBio Therapeutics Inc.