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恆瑞醫藥(600276.SH):昂丹司瓊口溶膜、對乙酰氨基酚甘露醇注射液獲批上市
格隆匯 02-11 15:39

格隆匯2月11日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》,藥品名稱為昂丹司瓊口溶膜、對乙酰氨基酚甘露醇注射液。

昂丹司瓊是一種選擇性5-HT3受體拮抗劑昂丹司瓊口溶膜適用於預防高致吐性化療引起的噁心嘔吐、預防中度致吐性化療引起的噁心嘔吐、預防放療引起的噁心嘔吐、預防手術後噁心/嘔吐。昂丹司瓊口溶膜是MonoSolRxLLC公司首先開發的一種止吐藥新劑型,2010年獲美國FDA批准上市,商品名為Zuplenz。目前國內上市銷售的劑型主要是鹽酸昂丹司瓊片、膠囊、口崩片和注射液,公司昂丹司瓊口溶膜為首仿上市。經查詢,2020年昂丹司瓊口溶膜全球銷售額約146萬美元。截止目前,昂丹司瓊口溶膜相關項目累計已投入研發費用約1802萬元。

對乙酰氨基酚是4-對氨基苯酚衍生物,具有陣痛和解熱作用。對乙酰氨基酚甘露醇注射液適用於輔助阿片類鎮痛藥緩解成人術後中重度疼痛。對乙酰氨基酚甘露醇注射液最早由Cadence公司開發,2010年獲美國FDA批准上市,商品名為Ofirmev。目前國內上市銷售的對乙酰氨基酚注射液主要通過肌肉注射給藥,公司對乙酰氨基酚甘露醇注射液通過靜脈注射給藥,為國內首仿上市。經查詢,2020年對乙酰氨基酚甘露醇注射液全球銷售額約2.91億美元。截止目前,對乙酰氨基酚甘露醇注射液相關項目累計已投入研發費用約1370萬元。

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