SAN FRANCISCO, July 10, 2024 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies for achieving functional cure in chronic hepatitis B (CHB) infection, today announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.

旧金山，2024年7月10日/PRNewswire/--AusperBio Therapeutics，Inc.和Ausper Biopharma Co.，Ltd.（统称AusperBio），一家临床阶段生物技术公司，致力于推进靶向寡核苷酸治疗，以实现慢性乙型肝炎（CHB）感染的功能性治愈，今天宣布他们的研究药物AHB-137已获得中国国家医药产品管理局（NMPA）药物评估中心（CDE）的突破性治疗指定（BTD）。

This designation accelerates AHB-137's development and potential access for patients..

该名称加速了AHB-137的发展和患者的潜在访问。。

The BTD was supported by clinical evidence from two parallel trials evaluating AHB-137's safety and efficacy in treating CHB patients, a Phase 1/2a trial conducted in China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993) and a Phase 1 trial conducted outside China (clinicaltrials.gov #NCT05717686).

BTD得到了两项评估AHB-137治疗CHB患者的安全性和有效性的平行试验的临床证据的支持，这是一项在中国进行的1/2a期试验（chinadrugtrials.org.cn#CTR20232098；clinicaltrials.gov#nct0615993）和一项在中国境外进行的1期试验（clinicaltrials.gov#NCT05717686）。

Results from these trials were presented in two late-breaker posters at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy..

这些试验的结果在意大利米兰举行的2024年欧洲肝脏研究协会（EASL）大会上的两张迟发海报上发表。。

Breakthrough Therapy Designation (BTD), AHB-137, Chronic Hepatitis B, Functional Cure, Clinical Trial

突破疗法名称（BTD），AHB-137，慢性乙型肝炎，功能治疗，临床试验

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Bella Lu, Regulatory Affairs Director at AusperBio, underscored that the BTD provides AHB-137 with expedited review status by the CDE, enabling timely communication and accelerated approval to address critical clinical needs. BTD does not change product approval standards but significantly expedites the regulatory process..

AusperBio监管事务总监Bella Lu强调，BTD为AHB-137提供了CDE的快速审查状态，从而能够及时沟通并加速批准，以满足关键的临床需求。BTD不改变产品批准标准，但大大加快了监管流程。。

' We are delighted by the NMPA's grant of Breakthrough Therapy Designation for AHB-137. This approval recognizes the promising clinical data collected to date and highlights the urgent need for substantial advancements in CHB treatment options,' said Bella Lu. 'The outstanding safety and efficacy results from our Phase 1/2a studies suggest that AHB-137 has the potential to improve upon current HBV therapies.

“我们很高兴NMPA授予AHB-137突破性治疗称号。Bella Lu说，这项批准承认了迄今为止收集到的有希望的临床数据，并强调了迫切需要在CHB治疗选择方面取得实质性进展。我们的1/2a期研究的突出安全性和有效性结果表明，AHB-137有可能改善目前的HBV治疗。

With NMPA's support, we aim to accelerate AHB-137's development further.'About NMPA Breakthrough Therapy DesignationThe Breakthrough Therapy Designation (BTD) is part of the recently revised Drug Registration Regulation, effective from July 1, 2020. The NMPA BTD program aims to accelerate the development and evaluation of medicines for serious or life-threatening diseases.

在NMPA的支持下，我们的目标是进一步加速AHB-137的发展。”关于NMPA突破疗法名称突破疗法名称（BTD）是最近修订的药物注册法规的一部分，自2020年7月1日起生效。。

This designation is granted based on preliminary clinical evidence indicating that the investigational therapy may offer substantial improvement over available therapies on at least one clinically significant endpoint. For a list of drugs granted BTD by NMPA, please click here.About AHB-137AHB-137, a novel unconjugated antisense oligonucleotide (ASO) developed within AusperBio's proprietary Med-Oligo™ ASO technology platform, was designed to treat chronic hepatitis B for a functional cure.

该名称是基于初步临床证据授予的，该初步临床证据表明，研究性治疗可能在至少一个具有临床意义的终点上比现有治疗提供实质性改善。有关NMPA授予BTD的药物列表，请单击此处。关于AHB-137AHB-137，一种在AusperBio专有的Med Oligo™ASO技术平台内开发的新型非共轭反义寡核苷酸（ASO），旨在治疗慢性乙型肝炎以实现功能性治愈。

Its compelling preclinical data was highlighted at the 2023 EASL™ conference. This novel dual-mechanism ASO is presently undergoing concurrent a Phase 1b trial across multiple international study sites and a Phase 2 trial in China. Through a global development strategy, AHB-137 is advancing rapidly towards the goal of HBV cure.About Chronic Hepatitis BChronic Hepatitis B infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases such as liv.

2023年EASL™会议强调了其引人注目的临床前数据。这种新型双机制ASO目前正在多个国际研究地点进行1b期试验，并在中国进行2期试验。通过全球发展战略，AHB-137正在朝着HBV治愈的目标迅速前进。关于慢性乙型肝炎慢性乙型肝炎感染是一种肝病，估计影响全球近2.9亿人，是导致liv等主要肝病的主要原因。