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奧賽康(002755.SZ):子公司獲艾曲泊帕乙醇胺片上市申請受理通知書
格隆匯 06-30 21:22

格隆匯 6 月 30日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司於近日收到國家藥品監督管理局下發的艾曲泊帕乙醇胺片新藥上市申請《受理通知書》。

艾曲泊帕乙醇胺片是諾華公司開發的一種非肽類血小板生成素受體激動劑,2008年11月獲得FDA批准上市,用於治療既往對糖皮質激素、免疫球蛋白等治療反應不佳的慢性免疫性(特發性)血小板減少症(ITP)。它是首個治療ITP的口服藥物,給藥更加方便,患者依從性高;明顯降低出血率,維持ITP患者的血小板計數,減少輸血;美國批准的適應症範圍更廣泛:除用於ITP成人,還批准用於一歲以上患兒。

原研艾曲泊帕乙醇胺片於2017年12月獲批進入中國,商品名為瑞弗蘭。2019年瑞弗蘭全球銷售額為14.16億美元。根據PDB數據庫,國內樣本醫院2019年銷售額119萬元。江蘇奧賽康藥業有限公司是國內第一家完成了臨牀生物等效性研究遞交生產註冊申請的企業。

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