China Securities Intelligent Finance News — On the evening of December 28, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical (01349) announced that it has received an "Acceptance Notice" from the National Medical Products Administration (NMPA). The Phase II clinical trial application for its self-developed Class 1 innovative drug, FZ-P001 Sodium for Injection, has been accepted. The drug is intended for the intraoperative visualization of malignant lesions in patients with known or suspected lung cancer.
According to the announcement, the drug is an innovative photosensitizer targeting folate receptor alpha (FRα). It utilizes near-infrared (NIR) fluorescence imaging technology to indicate residual tumor tissue and surgical margins during procedures, aiming to improve the surgical resection outcomes for solid tumors such as lung cancer. Citing relevant data, the announcement noted that in 2022, China saw 1.061 million new lung cancer cases and 733,000 deaths, with lung cancer ranking first in both incidence and mortality among malignant tumors.
The company stated that this registration application is for a new indication (lung cancer) to be conducted in Phase II trials, following the ongoing Phase I clinical trials of the drug for its ovarian cancer indication.

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