Core Viewpoint - Recently, the company announced that its self-developed global innovative radiolabeled drug conjugate (RDC) GPN01530 has received formal approval from the U.S. Food and Drug Administration (FDA) to initiate Phase I/II clinical studies for the diagnosis of solid tumors, marking a significant step in the company's global layout in the field of nuclear medicine for tumor diagnosis and treatment [1] Group 1 - GPN01530 is the first RDC product developed by the company to receive FDA approval for clinical research, which provides an important paradigm for the international development of the company's nuclear medicine product pipeline [1] - The successful approval of the clinical study for GPN01530 represents a significant milestone in the company's global research and registration process for nuclear medicine in tumor diagnosis and treatment [1] - This achievement reflects the company's comprehensive strength in building advanced nuclear medicine technology platforms, as well as in international clinical development and registration applications [1]
远大医药:自主研发的创新RDC药物GPN01530美国临床获批