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Hangzhou, China / July 22, 2025 - AusperBio (Ausper Biopharma Co., Ltd. and AusperBio Therapeutics Inc.), a clinical-stage innovative drug research and development company focusing on the development of self-innovative targeted delivery small nucleic acid drugs, is committed to achieving the goal of clinical cure for chronic hepatitis B. The company announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has approved the initiation of Phase III clinical trials for its core candidate drug, AHB-137.Yuansheng Ventures participated in AusperBio's Series A, Series B, and Series B+ financing rounds in July and December 2024, and May 2025, respectively.This Phase III clinical trial is a randomized, double-blind, multicenter study conducted in China, aiming to evaluate the efficacy and safety of AHB-137 at a dose of 300 mg over a 24-week treatment period in HBeAg-negative patients with chronic hepatitis B who are receiving stable nucleos(t)ide analog therapy.Chronic Hepatitis B (CHB) is a major global public health issue, with approximately290 Million, of which about China75,000,000, which can subsequently lead to severe complications such as liver cirrhosis and hepatocellular carcinoma. Although existing therapies can suppress viral replication, the majority of patients still struggle to achieve clinical cure.AHB-137It is a non-conjugated antisense oligonucleotide (ASO) drug that has the potential to become a cornerstone for clinical cure of chronic hepatitis B, and has gained widespread attention and recognition due to its significantly outstanding efficacy and safety.In July 2024, AHB-137 was approved by China's CDE and designated as a breakthrough therapy.In November 2024, the clinical Phase IIa treatment period data study results of AHB-137 were selected for the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD™) and presented as a late-breaking oral report.March 2025: Key data results from the Phase IIa clinical study of AHB-137 selected for oral presentation as a late-breaking abstract at the Asian Pacific Association for the Study of the Liver (APASL™) Annual Meeting;In May 2025, the end-of-treatment data from the Phase IIb clinical trial of AHB-137 was selected for presentation at the European Association for the Study of the Liver (EASL™) Annual Meeting and released as a breakthrough poster.Dr. Guozheng Cheng, Co-founder and CEO of AusperBio, stated"The approval by China CDE for AHB-137 to officially launch the Phase III clinical trial has greatly inspired us. Following the Breakthrough Therapy Designation received last year, this approval once again strongly validates the remarkable efficacy and safety demonstrated by AHB-137 in previous clinical studies, further solidifying our confidence in AHB-137 becoming a cornerstone drug for the clinical cure of chronic hepatitis B. This is not only an important milestone in AusperBio's development journey but also a significant landmark in the advancement of the entire hepatitis B virus (HBV) clinical cure field."Dr. Yang Chengyong, Co-founder and CSO of AusperBio, stated"AusperBio's achievement of this significant milestone is inseparable from the selfless dedication of researchers, clinical teams, trial participants, and our hardworking colleagues. We sincerely thank them. We will initiate this pivotal clinical trial as soon as possible to bring transformative treatment options to patients with chronic hepatitis B worldwide at the earliest opportunity."The approval of this Phase III clinical trial is a crucial step for AusperBio towards achieving the goal of clinical cure for chronic hepatitis B. A science-based, patient-centered R&D approach not only drives the paradigm shift in hepatitis B treatment from "control" to "cure," but also injects innovative momentum into the global drug development field.About AusperBio
AusperBio is a clinical-stage innovative drug development company operating simultaneously in China and the United States, committed to developing First-in-class and Best-in-class proprietary targeted delivery small nucleic acid drugs. AusperBio owns the proprietary Med-Oligo™ ASO patent technology platform, focusing on functional cures for chronic hepatitis B (HBV) and highly efficient targeted treatments for liver diseases, while also 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.
About AHB-137
AHB-137 is a non-conjugated antisense oligonucleotide (ASO) with the potential to become a cornerstone for the clinical cure of chronic hepatitis B. It is the first innovative drug from AusperBio's self-developed platform, Med-Oligo™, to enter clinical trials. Its excellent preclinical and clinical data have garnered widespread attention at the European Association for the Study of the Liver (EASL™ 2023, 2024, 2025) and the 2024 American Association for the Study of Liver Diseases (AASLD™). Currently, AHB-137 is simultaneously undergoing a global multicenter Phase I clinical trial and multiple Phase II clinical trials being conducted in China. Through a global strategic layout, the goal of achieving a clinical cure for hepatitis B is being accelerated.
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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. To date, it has completed investments in over 200 outstanding companies in the life sciences and health field, covering four major areas: novel drug development, medical devices, in vitro diagnostics and precision medicine, as well as healthcare services, achieving substantial investment returns. Among these, 20 companies have gone public on capital markets such as the Hong Kong Stock Exchange and the STAR Market. OrbiMed China has repeatedly been 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 world-class scientific advisory board, OrbiMed China boasts extensive experience in entrepreneurship, venture capital, and corporate operations within the biopharmaceutical industry. 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.
