Core Viewpoint - Fudan Zhangjiang has received the acceptance notice from the National Medical Products Administration for its self-developed injectable FZ-P001 sodium, aimed at visualizing malignant lesions during cancer surgery, marking a significant step in the development of innovative surgical solutions for tumor removal [1] Company Summary - The injectable FZ-P001 sodium is classified as a Class 1 new chemical drug, with its active ingredient being a conjugate of folate receptor-targeting small molecules and photosensitizers [1] - The drug is intended to enhance the effectiveness of surgical resection of solid tumors by indicating the presence of malignant tissue and the status of surgical margins [1] - This marks the first human Phase I clinical trial application for the drug, focusing on evaluating its safety, tolerability, and pharmacokinetic characteristics in humans [1] Industry Summary - The development of FZ-P001 sodium represents an innovative approach in the field of oncology, particularly in improving surgical outcomes for cancer patients [1] - The approval for the clinical trial reflects the growing interest and investment in advanced therapeutic solutions within the pharmaceutical industry [1]
复旦张江:注射用FZ-P001钠获得药物临床试验申请受理