四環醫藥(00460.HK):磺達肝癸鈉注射液獲批准生產
格隆匯12月21日丨四環醫藥(00460.HK)發佈公吿,集團開發的抗凝藥物磺達肝癸鈉注射液(規格:0.5毫升:2.5亳克)獲得中國國家藥品監督管理局頒發的藥品註冊批件,獲批准生產,視同通過仿製藥質量和療效一致性評價。
磺達肝癸鈉注射液適用於進行下肢重大骨科手術如髖關節骨折、重大膝關節手術或者髖關節置換術等患者,預防靜脈血栓栓塞事件的發生;用於無指徵進行緊急(<120分鐘)侵入性治療(PCI)的不穩定性心絞痛或非ST段抬高心肌梗死(UA/NSTEMI)患者的治療;用於使用溶栓或初始不接受其他形式再灌注治療的ST段抬高心肌梗死患者的治療。磺達肝癸鈉注射液屬國家醫保乙類(二零二一版)。該產品本次獲得藥品註冊批件,預計將有利於該產品未來的市場銷售和市場競爭,並將進一步惠及廣大患者,對集團的經營業績產生積極影響。
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