复旦张江(01349):注射用FZ-P001钠用于已知或疑似肺癌患者术中恶性病变可视化的II期临床试验申请获得受理
智通财经网·2025-12-28 11:47

Core Viewpoint - Fudan Zhangjiang (01349) has received approval from the National Medical Products Administration for the clinical trial application of FZ-P001 sodium injection, aimed at visualizing malignant lesions in known or suspected lung cancer patients during surgery [1] Group 1: Product Development - FZ-P001 sodium injection is a new class of chemical drug developed by the company, characterized as an innovative photosensitizer [1] - The active ingredient is a molecule that combines folate receptor-targeting small molecules with phthalocyanine-type photosensitizers, specifically targeting malignant tumor tissues that express high levels of folate receptor alpha (FRα) [1] - The company plans to utilize this drug to develop intraoperative fluorescence guidance technology to indicate the residual malignant tumor tissue and margin status during surgeries [1] Group 2: Clinical Trials - The application to the National Medical Products Administration also includes a registration for a Phase I clinical trial for the drug's use in visualizing malignant lesions during ovarian cancer surgery [1] - The company intends to conduct a Phase II clinical trial application for new indications of the drug [1]