海思科(002653.SZ):鹽酸帕洛諾司瓊注射液通過仿製藥一致性評價
格隆匯 2 月 24日丨海思科(002653.SZ)公佈,公司之全資子公司遼寧海思科製藥有限公司於近日收到國家藥品監督管理局下發的《藥品補充申請批准通知書》,鹽酸帕洛諾司瓊注射液通過仿製藥一致性評價。
公司開發的仿製產品鹽酸帕洛諾司瓊注射液,於2018年7月取得國家藥品監督管理局藥品註冊批件(批件號:2018S00437,藥品批准文號:國藥準字H20183343)。公司於2019年5月向國家藥品監督管理局提交一致性評價補充申請並獲受理。2021年2月,該產品正式獲批一致性評價。
鹽酸帕洛諾司瓊注射液屬於第二代長效5-HT3受體拮抗劑,與同類藥物如昂丹司瓊、格拉司瓊等相比,帕洛諾司瓊具有用量小,血漿蛋白結合率高,半衰期長等優點,對急性CINV(化療相關性惡心嘔吐)及延遲性CINV均優於傳統5-HT3受體拮抗劑,尤其是對延遲性CINV更具優勢。
經查詢,鹽酸帕洛諾司瓊注射液的原研公司為Helsinn
Healthcare SA公司,最早於2003年7月在美國上市,商品名Aloxi®,規格為5ml:0.25mg和1.5ml:0.075mg。隨後在歐洲多個國家上市銷售,如瑞士、愛爾蘭、法國、英國等,並於2018年獲批在中國上市。
據米內網數據,鹽酸帕洛諾司瓊注射液2019年在城市公立及縣級公立醫院銷售額近15億元,2020年上半年銷售額近6億元。
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