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恒瑞医药(01276.HK):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
Ge Long Hui· 2025-08-18 10:37
Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Haiqubopai Ethanolamine Tablets from the National Medical Products Administration, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1][2] Group 1: Drug Approval and Clinical Trials - The National Medical Products Administration has issued an acceptance notice for the drug application of Haiqubopai Ethanolamine Tablets, which is indicated for adult patients with chemotherapy-induced thrombocytopenia [1] - The Phase III clinical trial (SHR8735-301) for Haiqubopai Ethanolamine Tablets achieved its primary endpoint in May 2025, demonstrating significant efficacy compared to the control group with good safety and tolerability [1] Group 2: Existing Approvals and Market Context - Haiqubopai Ethanolamine Tablets have previously been approved for two indications: chronic primary immune thrombocytopenia in adults with poor response to corticosteroids and immunoglobulins, and severe aplastic anemia in adults with poor response to immunosuppressive therapy [2] - The drug is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production through the activation of TPO-R mediated STAT and MAPK signaling pathways [2] - Similar products available in the international market include Eltrombopag, Avatrombopag, and Lusutrombopag, with a combined global sales forecast of approximately $2.59 billion for 2024 [2] - The cumulative R&D investment for Haiqubopai Ethanolamine Tablets has reached approximately 445.87 million yuan [2]