Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. has announced that it has received an Acceptance Notice from the National Medical Products Administration (NMPA) of China for its investigational new drug application. The approval allows the company to proceed with a Phase II clinical trial of FZ-P001 Sodium for Injection, a class 1 innovative new drug intended for intraoperative visualization of malignant lesions in patients with known or suspected lung cancer. The company will continue to advance the project and comply with all information disclosure obligations in line with regulatory requirements. No other beneficiary organizations were mentioned.
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