百利天恒(688506.SH)：BL-ARC001用于在晚期实体瘤治疗获得临床试验批准通知书

Core Viewpoint - The company, BaiLi TianHeng (688506.SH), has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative drug, Lutetium-177-BL-ARC001 injection (referred to as "BL-ARC001") [1] Group 1: Clinical Trial Approval - The clinical trial for BL-ARC001 has been approved for late-stage solid tumors, meeting the requirements for drug registration as per the Drug Administration Law of the People's Republic of China [1] - BL-ARC001 is the company's first Class I innovative drug in the field of antibody-radionuclide conjugates (ARC) and is a potential first-in-class ARC drug with fully independent intellectual property rights [1] Group 2: Drug Characteristics - BL-ARC001 utilizes antibody-mediated precise targeted delivery technology and the powerful tumor-killing ability of radionuclides, offering stronger target specificity and higher tumor enrichment compared to traditional radionuclide conjugated drugs [1] - The drug is expected to demonstrate better resistance to drug resistance [1]