FUDAN ZHANGJIANG (01349): The application for Phase II clinical trial of injection FZ-P001 sodium for visualizing malignant lesions in known or suspected lung cancer patients during surgery has been accepted.
Fudan Zhangjiang (01349) announces that the company has received the "Acceptance Notice" issued by the National Medical Products Administration for the Injection of Sodium FZ-P001, which is used in the II phase clinical trial application for visualizing malignant lesions in patients with known or suspected lung cancer during surgery.
FUDAN ZHANGJIANG (01349) announced that the company has received the Approval Notification from the National Medical Products Administration for the application of phase II clinical trials of injection FZ-P001 sodium for visualizing malignant lesions in patients with known or suspected lung cancer during surgery.
Injection FZ-P001 sodium is a class 1 new chemical compound independently developed by the company. It is an innovative photosensitizer that targets the folate receptor with a small molecule and a porphyrin photosensitizer, which can target malignant tumor tissues with high folate receptor (FR) expression and fluoresce in the near-infrared range. The company plans to use this drug to develop intraoperative fluorescence guidance technology to indicate the residual malignant tumor tissues and margin status, aiming to improve the surgical resection effect of related solid tumors (such as ovarian cancer, lung cancer, etc.) and provide an innovative solution for precise navigation surgery in oncology with molecular targeting specificity and multidimensional biological awareness.
In addition, the company has applied for registration with the National Medical Products Administration for the use of this drug in visualizing malignant lesions in patients with ovarian cancer during phase I clinical trials, and plans to apply for phase II clinical trials for new indications.
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