东诚药业：氟[18F]思睿肽注射液完成III期临床试验

Core Viewpoint - Dongcheng Pharmaceutical announced that its subsidiary, Lanacheng, has completed two Phase III clinical trials for the fluorine-18 labeled peptide injection, demonstrating effective diagnostic performance and safety for prostate cancer patients [1] Group 1: Clinical Trial Results - The two studies, 18F-LNC1001-C002 and 18F-LNC1001-C003, targeted newly diagnosed and biochemically recurrent prostate cancer patients [1] - Both trials achieved preset goals in diagnostic efficacy, with specificity and sensitivity meeting the required standards [1] - No serious adverse reactions were reported during the trials [1] Group 2: Regulatory Actions - The company plans to submit a new drug application based on the successful trial results [1]