奧賽康(002755.SZ):子公司注射用福沙匹坦雙葡甲胺上市申請獲受理
格隆匯8月9日丨奧賽康(002755.SZ)公佈,公司全資子公司江蘇奧賽康藥業有限公司近日收到國家藥監局下發的注射用福沙匹坦雙葡甲胺上市許可申請《受理通知書》。
福沙匹坦是阿瑞匹坦的前體藥,阿瑞匹坦通過選擇性阻斷NK-1受體抑制化療藥物所致嘔吐,主要適用於預防初次和重複使用中、高度致吐性抗腫瘤化療藥物引起的急性和遲發性噁心和嘔吐。注射用福沙匹坦雙葡甲胺最早是由默克公司研發,於2008年在美國和歐洲上市。公司於2022年7月提交藥品上市註冊申請於近日獲得正式受理。
噁心嘔吐是抗腫瘤化療應用過程中最常見的不良反應之一,稱為化療相關性惡心嘔吐(CINV)。早期,多巴胺受體拮抗劑和糖皮質激素是用於止吐治療的主要藥物,因其不良反應較多應用受限。NK-1受體拮抗劑對急性CINV作用與5-HT3受體拮抗劑效果相當,對延遲性CINV療效更優。阿瑞匹坦是第一個用於CINV止吐的NK-1受體拮抗劑,上市後療效顯著。在MASCC/ESMO指南中,阿瑞匹坦聯合5-HT3拮抗劑、地塞米松,已成為預防高度致吐性抗腫瘤化療藥物引起的急性和延遲性CINV的標準方案。福沙匹坦靜脈注射製劑的成功上市,是對止吐藥物的進一步補充和提高。
PDB數據庫顯示150mg規格本品於2020年中國樣本醫院銷售額約6000萬元,2021年銷售額近2.6億元,2022年截止到第一季度銷售額已超過7000萬元。
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