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恒瑞医药:海曲泊帕乙醇胺片的药品上市许可申请获国家药监局受理

Core Viewpoint - Heng Rui Medicine has received acceptance notification from the National Medical Products Administration for its drug application of Haequibopam Ethanolamine Tablets, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1] Group 1: Drug Development - The Phase III clinical trial (SHR8735-301) for Haequibopam Ethanolamine Tablets achieved its primary research endpoint as planned in May 2025 [1] - The study evaluated the efficacy and safety of Haequibopam Ethanolamine Tablets in patients with chemotherapy-induced thrombocytopenia through a multicenter, randomized, double-blind, placebo-controlled design [1] - A total of 213 adult patients with chemotherapy-induced thrombocytopenia were enrolled in the study, led by Professor Ma Jun from Harbin First Hospital and Professor Qin Shukui from Nanjing Tianyinshan Hospital [1] Group 2: Study Results - The results indicated that the treatment group significantly outperformed the control group on the primary efficacy endpoint [1] - The safety and tolerability of Haequibopam Ethanolamine Tablets were reported to be good [1]