AusperBio Announces Positive Phase II Functional Cure Results of AHB-137 in Treatment-Naïve Chronic Hepatitis B Patients at EASL 2026

May 28, 2026 09:25 CST Updated 09:25

AusperBio

Biological Vaccine and Nucleic Acid Drug Developer

Click the blue text to follow us

Sherpa Capital-Backed AusperBio's Pipeline DrugsEnd-of-treatment and follow-up data from the Phase II clinical trial of AHB-137 in treatment-naïve chronic hepatitis B (CHB) patients (without nucleos(t)ide analogue background therapy) were first presented at the EASL Congress 2026. The results demonstrated that 16 weeks of AHB-137 monotherapy rapidly and potently suppressed HBV DNA and achieved HBsAg clearance. Follow-up data at 24 weeks post-treatment indicated that the virological response and antigen clearance status were durably sustained after treatment discontinuation, achieving a clinical cure rate of 70% in patients with baseline HBsAg levels of 100–1000 IU/mL.

AusperBio, a portfolio company of Sherpa Capital, first presented the end-of-study follow-up data from the Phase II clinical trial of its investigational drug AHB-137 for treatment-naïve chronic hepatitis B (without nucleos(t)ide analogue background therapy) at the EASL 2026 Congress. The results showed that,16 weeks of AHB-137 monotherapy rapidly and potently suppresses HBV DNA and achieves HBsAg clearance. Follow-up data at 24 weeks post-treatment discontinuation demonstrate that the virologic response and antigen clearance status are durably maintained, with a clinical cure rate of 70% in patients with baseline HBsAg levels of 100–1000 IU/mL.AHB-137 demonstrated a favorable safety and tolerability profile in treatment-naïve patients, with commonly observed drug-related adverse events largely consistent with previous reports.

AusperBio is a clinical-stage innovative biopharmaceutical company operating synchronously in China and the United States, focusing on the development of proprietary targeted delivery oligonucleotide therapeutics with first-in-class and best-in-class potential. On May 27, the company announced the presentation of end-of-follow-up data from its Phase II clinical trial of AHB-137, an independently developed antisense oligonucleotide (ASO) drug for treatment-naïve chronic hepatitis B (CHB) patients in mainland China, at the 2026 European Association for the Study of the Liver (EASL) Congress (AB-10-8008, NCT06829329).

As a candidate drug based on AusperBio’s independently developed innovative first-generation Med-Oligo™ ASO technology platform, AHB-137 has previously demonstrated excellent efficacy and a favorable safety profile in NA-treated HBeAg-negative patients. The recently announced study results further validate its therapeutic potential in treatment-naïve chronic hepatitis B patients, representing a broader chronic hepatitis B population.

Sherpa Capital invested in AusperBio's Series B financing in 2024 and has continued to support the company in subsequent rounds.

Abstract

Report Number: LBP-031

Report Title: AHB-137 monotherapy elicits high functional cure rates and sustained DNA suppression in treatment-naïve chronic hepatitis B participants: results from an ongoing phase II study

Report Date: 2026-05-27

Report Authors: Yunqing Qiu*, Haibing Gao, Dazhi Zhang, Youwen Tan, Meihong Yu, Xiaowei Xu, Xiangmei Wang, Shan Zhong, Xingbei Zhou, Mingyue Chen, Kaili Zhang, Chen Yang, Yeming Pan, Di Zhao, Miao Wang, Chris Yang, Guofeng Cheng, and Hao Wang

Led by The First Affiliated Hospital, Zhejiang University School of Medicine, this randomized, double-blind, placebo-controlled Phase II clinical trial enrolled treatment-naïve patients with chronic hepatitis B, with baseline HBsAg levels of 100–10,000 IU/mL and HBV DNA levels of 20–2,000 IU/mL. Subjects received once-weekly AHB-137 (300 mg) or placebo for 16 weeks, followed by a 24-week treatment-free follow-up period. The primary endpoint was complete response (CR) at the end of treatment (EOT), defined as HBsAg <0.05 IU/mL and HBV DNA <10 IU/mL; clinical cure was defined as maintaining CR 24 weeks after treatment cessation.

Study results demonstrate that AHB-137 monotherapy rapidly and profoundly suppresses HBV DNA replication. After 16 weeks of treatment, 100% of subjects achieved HBV DNA negativity (<10 IU/mL), demonstrating potent viral suppression.

Meanwhile, AHB-137 also demonstrated significant clearance of hepatitis B surface antigen (HBsAg): in the overall population with baseline HBsAg levels of 100–10,000 IU/mL, 76% of patients achieved HBsAg clearance at the end of treatment; in patients with baseline HBsAg ≤ 3,000 IU/mL, 84% of patients achieved HBsAg clearance; in patients with baseline HBsAg > 3,000 IU/mL, HBsAg reductions exceeded 4.5 log10 IU/mL, and 50% of patients achieved HBsAg clearance. Overall, 68% of patients achieved a complete response (CR) at the end of treatment (EOT).

Of particular note, 24 weeks after treatment discontinuation, 32% of the overall population (i.e., baseline HBsAg 100–10,000 IU/mL) achieved clinical cure (FC). Among patients with baseline HBsAg 100–1,000 IU/mL, the clinical cure rate was 70%. In patients with baseline HBsAg > 1,000 IU/mL, 33% achieved a 'partial cure' state (sustained suppression of HBV DNA and HBsAg < 10 IU/mL).

In terms of safety, AHB-137 was generally well tolerated, consistent with previous study results. The vast majority of treatment-related adverse events (TRAEs) were Grade 1–2, primarily manifesting as injection site reactions and laboratory abnormalities. Reversible elevations in ALT/AST observed concomitant with the rapid decline in HBsAg were consistent with prior findings in the nucleos(t)ide analogue-experienced population.

Professor Qiu Yunqing - Former Executive Vice President of The First Affiliated Hospital, Zhejiang University School of Medicine, Executive Deputy Director of the National Medical Center for Infectious Diseases

Professor Qiu Yunqing stated：The World Health Organization has set the strategic goal of ‘eliminating viral hepatitis as a public health threat by 2030.’ However, the current treatment rate hovers at only 15–20%. One of the major barriers contributing to this situation is that existing standard-of-care therapies require lifelong medication. Consequently, upon diagnosis, a substantial number of patients delay or even forgo treatment due to the psychological burden, financial strain, and lifestyle disruptions associated with long-term pharmacotherapy.

The treatment-naïve data for AHB-137 presented at EASL offers a new possibility for resolving this clinical challenge. Among patients with baseline HBsAg levels of 100–10,000 IU/mL, 32% achieved a functional cure (FC). In patients with baseline HBsAg levels of 100–1,000 IU/mL, the functional cure rate reached 70%. This ‘finite treatment duration to achieve functional cure’ model is expected to significantly improve treatment willingness and adherence among treatment-naïve patients, truly driving the management of chronic hepatitis B from ‘passive long-term control’ to ‘proactive functional cure’.

Dr. Guofeng Cheng - AusperBio Co-Founder & CEO

Dr. Guofeng Cheng stated：The recently released treatment-naïve data from EASL 2026 robustly validates the unique advantages of AusperBio's Med-Oligo™ targeted delivery technology: AHB-137 precisely targets HBV transcripts within hepatocytes, blocking viral protein synthesis at the source to achieve profound viral suppression and rapid antigen clearance; meanwhile, its unique immunomodulatory mechanism facilitates sustained virological clearance.

The encouraging clinical data from the treatment-naïve population mark a pivotal step in the clinical development of AHB-137. Its demonstrated potential for a "finite treatment duration and high cure rate" precisely addresses the unmet clinical needs in current chronic hepatitis B management, offering a new therapeutic option for treatment-naïve patients. We will fully accelerate the clinical advancement of AHB-137, committed to bringing this China-originated innovative therapy to the global market, and contributing new Chinese innovation to achieving the WHO's goal of "eliminating viral hepatitis as a public health threat by 2030."

About AHB-137

AHB-137 is a novel unconjugated ASO drug developed by AusperBio based on its proprietary Med-Oligo™ antisense oligonucleotide technology platform. Currently positioned as an investigational therapy, it aims to achieve a 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 authoritative international conferences including EASL (2023–2025), AASLD (2024–2025), and APASL 2025. AHB-137 has completed global Phase I clinical trials and is concurrently advancing multiple global Phase II clinical trials alongside a Phase III clinical trial in mainland China.

About AusperBio

AusperBioAusperBio is a clinical-stage innovative drug development company operating concurrently in China and the United States, dedicated to the research and development of proprietary first-in-class and best-in-class targeted delivery small nucleic acid therapeutics. AusperBio holds a proprietary Med-Oligo™ ASO patented technology platform, focusing on the functional cure of chronic hepatitis B (HBV) and highly efficient targeted therapies for liver diseases, while expanding its targeted small nucleic acid therapeutic pipeline to novel extrahepatic targets. AusperBio's strategy is to integrate its internationally leading Med-Oligo™ oligonucleotide technology with highly specific and efficient targeting platforms, thereby addressing a broad spectrum of currently unmet medical needs.

About

Sherpa Investment

Sherpa Capital is a fund management company specializing in early-stage and growth-stage healthcare investments. We adhere to the philosophy of "investing early, investing in innovation, and investing precisely,"Based on long-term accumulated industry insights and strategic resources,Addressing critical unmet clinical needs in major disease areas, the investment portfolio is structured around key sectors including gene technology and applications, biopharmaceuticals, diagnostic devices, and digital healthcare. It expands vertically across the upstream and downstream value chain to foster synergies among portfolio companies, with strategic investment footprints established in both China and the United States.

The Sherpa team combines industry expertise with investment acumen. By actively sharing operational management experience with partners and providing a forward-looking perspective across the entire industry value chain, we support critical decision-making at pivotal stages of corporate development, helping enterprises achieve growth in both operational performance and corporate value. A decade of dedicated refinement, driven by long-term professional focus and continuous learning, has forged the Sherpa Investment brand and established a comprehensive capability system encompassing project sourcing, post-investment value-added services, and exit strategies.

Sherpa Capital team members have led or participated in investments in over 100 domestic and international healthcare companies, including Innovent Biologics, Kelun-Biotech, Faith Bioscience, Berry Genomics, NanoVision, Singleron Biotechnologies, Northchip, WuXi AppTec, WuXi Biologics, Cytek, Axonics, Urotronic, Visen, Avida, Alamar, Bota, Vazyme, Obio Technology, CardioCare Medical, OliveTree Health, HealthSea Technology, MicroCon Biotech, and others.

Upholding the core value of “Investing in Health, Empowering Others for Mutual Success,” the Sherpa team is honored to join hands with numerous outstanding entrepreneurs. Through innovative technologies and products that advance human health, we have jointly participated in and witnessed the growth of China’s healthcare industry, and we are committed to becoming the most trusted Sherpas for entrepreneurs striving to scale the Everest of life sciences.

Invest in Health, Empower Others, Achieve Ourselves
Be Great，Make Others Great

END