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复旦张江:获得药物上市申请受理通知书
Zhong Zheng Wang· 2026-01-31 08:48
Core Viewpoint - Fudan Zhangjiang Biopharmaceutical Co., Ltd. has received acceptance for its drug application for a powder oral solution of Ammonium Pentanoate Hydrochloride, aimed at visualizing malignant tissues during surgery for adult patients with high-grade malignant glioma [1] Group 1 - The drug application was accepted by the National Medical Products Administration, indicating progress in the regulatory process [1] - The clinical trial application for the drug was accepted in December 2023, with verification clinical research set to start in June 2024 [1] - The clinical research for the drug has been completed, leading to the recent acceptance of the drug registration application [1]