AusperBio Announces Major Clinical Progress of AHB-137, a Novel ASO Therapy for Functional Cure of Chronic Hepatitis B

HANGZHOU, China / July 6, 2024 - AusperBio (Ausper Biopharma Co., Ltd. and AusperBio Therapeutics, Inc.), a clinical-stage biopharmaceutical company dedicated to advancing targeted oligonucleotide therapies and leading innovation in hepatitis B cure, today announced significant progress in the clinical development of AHB-137, an innovative drug from its leading Med-Oligo™ technology platform. AHB-137, a non-conjugated antisense oligonucleotide (ASO) innovative drug, specifically targets all HBV mRNAs and has great potential to become a cornerstone drug in future combination therapies for curing hepatitis B.

Key Clinical Progress:

As of now, the AHB-137 clinical trial has recruited 193 subjects, including 101 patients with chronic hepatitis B, and has obtained early clinical data on the efficacy and safety of the drug in patients with chronic hepatitis B. Since February 2024, we have achieved the following key clinical advancements:

• The last follow-up for all subjects in the Phase Ib clinical trial in China has been successfully completed.

• International Multicenter Clinical Phase Ib Completes Enrollment of All Chronic Hepatitis B Subjects;

• At the 2024 EASL™, the Phase I clinical trial data of AHB-137 was presented in the form of a latest breakthrough poster;

• The Phase IIa clinical trial in China has completed the enrollment of all chronic hepatitis B subjects.

• Successfully Achieved Large-Scale Non-Commercial Production of AHB-137.

Dr. Guozheng Cheng, Co-founder and CEO of AusperBio, stated"We are very excited about the milestones achieved in the AHB-137 clinical project in the first half of the year. The significant clinical efficacy and favorable safety data of AHB-137 have garnered widespread attention at this year's EASL™ conference. The success in CMC will further accelerate the clinical development of AHB-137. Here, I would like to express my sincere gratitude to our principal investigators (PIs), clinical team, participants, and the AusperBio team for the interim achievements made in the first half of the year."

Co-founder and CSO Dr. Yang Chengyong added,"The efficient completion of patient enrollment in the domestic Phase IIa clinical trial this time allows us to validate the safety and efficacy of AHB-137 in treatments exceeding four weeks more quickly. We are very excited about the new data and plan to publicly release the interim analysis report at a major international conference in the second half of this year."

This significant progress marks a solid step forward for AusperBio in achieving a functional cure for chronic hepatitis B. We will continue to dedicate ourselves to innovation, bringing more hope and health to patients worldwide.

About AHB-137:

AHB-137 is a non-conjugated antisense oligonucleotide (ASO) with the potential to become a cornerstone for the functional cure of chronic hepatitis B. It is the first innovative drug from AusperBio's self-developed platform, Med-Oligo™, to enter clinical trials, and its excellent preclinical data received widespread attention at the 2023 EASL™ conference. Currently, AHB-137 is simultaneously undergoing a global multicenter Phase I clinical trial and a Phase II clinical trial in China, accelerating the goal of achieving a functional cure for hepatitis B through a global strategic layout.

About Chronic Hepatitis B:

Hepatitis B (HBV) is a major global health issue.^[1]According to estimates by the World Health Organization (WHO), in 2022, 290 million people were infected with chronic hepatitis B, with an estimated 1.2 million new infections and 1.1 million deaths annually.^[1]The clearance of hepatitis B surface antigen (HBsAg) is considered the optimal endpoint of treatment, also known as "functional cure."^[2]. However, current treatment methods rarely achieve this goal, so there is an urgent need for innovative therapies that can achieve functional cures.^[3]。

About AusperBio:

AusperBio, a clinical-stage innovative drug development company operating simultaneously in China and the United States, is committed to developing First-in-class and Best-in-class self-innovative targeted delivery small nucleic acid drugs. AusperBio owns the proprietary intellectual property rights of the 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 technology to address a wide range of currently unmet medical needs.