恆瑞醫藥(600276.SH):海曲泊帕乙醇胺片藥品上市許可申請獲受理
格隆匯8月12日丨恆瑞醫藥(600276.SH)公佈,收到國家藥品監督管理局下發的《受理通知書》,公司海曲泊帕乙醇胺片的藥品上市許可申請獲國家藥監局受理,適應症爲:適用於既往對糖皮質激素、免疫球蛋白等治療反應不佳的持續性及慢性原發免疫性血小板減少症(ITP)成人及≥6歲的兒童患者。
海曲泊帕乙醇胺片是一種口服非肽類血小板生成素受體(TPO-R)激動劑,通過激活TPO-R介導的STAT和MAPK信號轉導通路,促進血小板生成。經查詢,目前國外已有同類產品上市,包括Eltrombopag(葛蘭素史克/諾華,商品名Promacta)、Avatrombopag(DovaPharmaceuticals,商品名Doptelet)和Lusutrombopag(Shionogi,商品名Mulpleta)。在國內,Eltrombopag於2017年獲批上市,產品名稱爲艾曲泊帕乙醇胺片;Avatrombopag於2020年獲批上市,產品名稱爲馬來酸阿伐曲泊帕片;Lusutrombopag於2023年獲批上市,產品名稱爲蘆曲泊帕片。經查詢EvaluatePharma數據庫,2024年上述同類產品全球銷售額合計約爲25.9億美元。截至目前,海曲泊帕乙醇胺片相關項目累計研發投入約44,587萬元。
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