恒瑞医药(01276):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
智通财经网·2025-08-12 09:16

Core Viewpoint - Heng Rui Medicine (01276) has received acceptance from the National Medical Products Administration for its drug application of Haequparbopamine tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to corticosteroids and immunoglobulins [1] Group 1 - The drug application for Haequparbopamine tablets is specifically for patients with primary immune thrombocytopenia (ITP) who have not responded well to previous treatments [1] - The Phase III clinical trial (HR-TPO-ITP-III-PED) for Haequparbopamine tablets achieved its primary endpoint as planned in March 2025 [1] - The study was a multicenter, randomized, double-blind, and open-label Phase III trial evaluating the efficacy and safety of Haequparbopamine tablets in children and adolescents with ITP, led by Professor Wang Tianyou from Beijing Children's Hospital [1] Group 2 - A total of 100 cases of children and adolescents aged 6 and above with primary immune thrombocytopenia were enrolled in the trial [1] - The treatment group showed significant superiority over the control group in achieving the primary endpoint [1] - Long-term treatment demonstrated good safety and efficacy [1]