海思科(002653.SZ)獲得複方氨基酸注射液(18AA-IX)藥品註冊批件
格隆匯12月22日丨海思科(002653.SZ)公佈,公司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《藥品註冊批件》。2012年12月26日,遼寧海思科向遼寧省食品藥品監督管理局提交報產申請並獲受理,並於近日正式批准生產,獲得《藥品註冊批件》。
複方氨基酸注射液(18AA-IX)(ネオアミユー輸液)原研為日本味之素製藥株式會社,商品名稱“Neoamiyu”(中文名:綠參安),1996年在日本上市銷售。目前國內共廣州綠十字製藥有限公司、遼寧海思科製藥有限公司兩家企業獲得該藥品的生產批件。
複方氨基酸注射液(18AA-IX)是必需氨基酸和非必需氨基酸的複方製劑。本品所含氨基酸的種類、必需氨基酸與非必需氨基酸的比值及各種氨基酸的量均恰當配伍,可提供營養支持,補充氨基酸,改善患者體內的氮平衡,是國內唯一含18種氨基酸的腎病專用氨基酸輸液。
有文獻證明,腎病適用型氨基酸(18AA-IX)為腎功能不全患者帶來明顯臨牀獲益:能有效糾正腎功能不全患者紊亂血漿氨基酸譜;加速腎功能不全患者蛋白合成,避免酸中毒發生;相比腎病適用型氨基酸9AA,18AA-IX治療腎功能不全患者的總體安全性和獲益性更高。
根據2019年IQVIA中國醫院市場Q3數據顯示,氨基酸市場年滾動銷售額33.23億元,其中腎病適用型氨基酸年銷售額0.93億元,市場佔比增長至2.8%。腎病適用型氨基酸近年銷售快速增長,增幅遠大於氨基酸整體市場及其他種類氨基酸。截止目前,公司在複方氨基酸注射液(18AA-IX)的研發投入約280萬元。
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