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), 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 infected.

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."