四川百利天恒药业股份有限公司自愿披露关于BL-ARC001用于在晚期实体瘤治疗获得临床试验批准通知书的公告

Core Viewpoint - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative drug, Lutetium [177Lu]-BL-ARC001 injection, aimed at treating advanced solid tumors [1][2]. Group 1: Clinical Trial Approval - The clinical trial approval notification for BL-ARC001 has been officially issued, allowing the company to conduct trials for drug registration in China [1]. - The product is classified as a Class I innovative drug and is the company's first antibody-radionuclide conjugate (ARC) with potential global first-in-class status [2]. Group 2: Drug Characteristics - BL-ARC001 utilizes antibody-mediated targeted delivery technology combined with the powerful tumor-killing ability of radionuclides, offering stronger target specificity and higher tumor accumulation compared to traditional radionuclide conjugates [2]. - The drug is expected to demonstrate better resistance to drug tolerance, enhancing its therapeutic potential [2].