Fudan-Zhangjiang's FZ-P001 sodium receives acceptance notice

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (HKEX: 1349) announced today that it has received an Acceptance Notice from the National Medical Products Administration of the PRC (NMPA) for its investigational new drug application concerning FZ-P001 Sodium for Injection. The drug, classified as a class 1 innovative chemical drug, is intended as an adjunct for the intraoperative identification of malignant cancer lesions. The application, with Acceptance No. CXHL2500576, covers the registration of a clinical trial for domestic production of the pharmaceutical product. FZ-P001 Sodium for Injection is described as an innovative photosensitizer developed by the Company to allow fluorescence imaging in the near-infrared spectrum, offering an integrated solution for precision-guided tumor surgery. The application to the NMPA pertains to a first-in-human Phase I clinical trial designed to evaluate the drug's safety, tolerability, and pharmacokinetic characteristics in humans.