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奧賽康(002755.SZ):鹽酸帕洛諾司瓊注射液獲得補充申請批准通知書
格隆匯 12-07 19:55

格隆匯 12 月 7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(“江蘇奧賽康”)於近日收到國家藥品監督管理局(“藥監局”)下發的鹽酸帕洛諾司瓊注射液《藥品補充申請批准通知書》。

鹽酸帕洛諾司瓊為選擇性的5-HT(35-羥色胺3)受體拮抗劑,由美國Helsinn公司與其合作伙伴美國MGI製藥公司共同研發,2003年在美國獲得批准,商品名為Aloxi®,規格為5ml:0.25mg(以帕洛諾司瓊計),用於預防化療引發的噁心和嘔吐(CINV),2005年在歐盟上市;2008年FDA批准本品用於預防手術後24小時內的噁心、嘔吐(PONV),增加規格1.5ml:0.075mg。2014年FDA批准用於兒童(1月到17歲)預防化療引發的噁心和嘔吐(CINV)。

鹽酸帕洛諾司瓊為第二代 5-HT3受體拮抗劑,與前述第一代止吐藥不同的是,該藥是第一個獲准用於預防遲發性化療所致噁心、嘔吐的5-HT3受體拮抗劑。本品對急性和遲發性化療所致噁心、嘔吐都表現出較高的應答率,而且止吐作用持續時間更長,一次性給藥作用持續時間可達6天,可跨越多個化療週期,克服了需在不同階段多次給藥的缺陷,患者的用藥依從性顯著改善。此外,鹽酸帕洛諾司瓊通過與糖皮質激素(地塞米松)聯用,可顯著提高5-HT3受體拮抗劑預防急性嘔吐的療效。目前,該聯用方案已被多個國家和地區收錄,為急性化療藥物所致噁心、嘔吐的標準治療方案。與阿瑞匹坦聯用也加強了對CINV的控制效果,受到業界的廣泛關注,此方法也寫入了2008年版的美國國家綜合癌症網(National Comprehensive Cancer Network,NCCN)指南推薦中。PDB數據庫顯示2019年中國樣本醫院銷售額達6.4億元,市場潛力大。

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