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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd.: The clinical trial application for injectable FZ-P001 sodium has been accepted.

Breakings ·  Jun 16 17:28

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. announced that its self-developed injectable FZ-P001 sodium, used for intraoperative visualization of malignant lesions in cancer, has received the acceptance notice issued by the National Medical Products Administration, and its phase I clinical trial application has been accepted. Injectable FZ-P001 sodium is a new class of chemical drug compound, with the active component being a small molecule targeted at folate receptors coupled with a phthalocyanine photosensitizer. It is planned for developing intraoperative fluorescence guidance technology to indicate the residue of malignant tumor tissue and the status of surgical margins, aiming to improve the surgical resection outcomes of solid tumors and provide innovative solutions for tumor surgery. This registration application marks the first phase I clinical trial in humans, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of the drug in humans.

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