必贝特：BEBT-701临床试验申请获得国家药品监督管理局批准

Core Viewpoint - The company, Bibet (688759.SH), has received approval from the National Medical Products Administration (NMPA) to conduct I-II phase clinical trials for its innovative siRNA drug, BEBT-701, aimed at treating mild to moderate hypertension combined with elevated low-density lipoprotein cholesterol (LDL-C) levels [1][2]. Group 1: Company Developments - BEBT-701 is the first drug developed using the company's proprietary GalNAc dual oligonucleotide conjugate (GDOC) technology platform, designed to silence two key targets, angiotensinogen (AGT) and proprotein convertase subtilisin/kexin type 9 (PCSK9), simultaneously [1]. - The drug aims to provide a long-acting, low-frequency administration solution for managing chronic diseases, improving adherence among high cardiovascular risk populations [1]. Group 2: Clinical and Non-Clinical Research - Non-clinical studies have demonstrated that BEBT-701 achieves efficient and durable gene silencing of AGT and PCSK9 in humanized mouse models and non-human primates, showing synergistic effects in lowering blood pressure and cholesterol levels with good safety profiles [1]. - The World Health Organization's Global Hypertension Report indicates that approximately 1.4 billion people worldwide suffer from hypertension, with around 245 million adults affected in China, highlighting the significant market potential for effective treatments [2]. Group 3: Industry Context - The use of siRNA drugs, such as BEBT-701, represents a shift towards low-frequency, precise, and stable management of cardiovascular metabolic diseases, addressing issues related to long-term medication adherence and fluctuations in drug concentration [2].