百利天恒首款抗体放射性核素偶联药物获临床试验许可

Core Viewpoint - The approval of the clinical trial application for the first antibody-radionuclide conjugate drug, Lutetium [177Lu]-BL-ARC001, by the National Medical Products Administration (NMPA) marks a significant advancement for the company in the field of nuclear medicine [1] Group 1: Product Development - Lutetium [177Lu]-BL-ARC001 is the company's first Class I innovative drug developed based on its proprietary HIRE-ARC platform [1] - The drug is intended for use in patients with locally advanced or metastatic solid tumors who have failed standard treatment or cannot access standard treatment [1] - The HIRE-ARC platform integrates antibody-mediated targeted delivery technology with the powerful tumor-killing ability of radionuclides, showcasing the company's commitment to innovative drug development [1] Group 2: Intellectual Property and Market Position - The drug represents a potential global first-in-class (First-in-class) ARC drug, highlighting the company's complete ownership of intellectual property rights [1] - The company plans to continue developing a series of ARC candidate innovative drugs based on the HIRE-ARC platform, indicating a strategic focus on expanding its product pipeline in the nuclear medicine sector [1]