健友股份(603707.SH):磺達肝癸鈉注射液獲批上市
格隆匯7月7日丨健友股份(603707.SH)公吿,公司於近日收到國家藥品監督管理局關於核准簽發磺達肝癸鈉注射液(規格:0.5ml:2.5mg)藥品註冊證書的通知(藥品批准文號:國藥準字H20213568)。
磺達肝癸鈉是針對凝血X因子的一種新型的人工合成抗凝劑,其對IIa因子無作用,出血的不良反應少,只能抑制遊離的Xa因子,不抑制與凝血酶原酶結合的Xa因子,無需監測PT(凝血酶原時間)、APTT(部分凝血酶原時間),具有生物利用度高、起效快、半衰期長等優點。
據悉,磺達肝癸鈉臨牀上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它形式再灌注治療的ST段抬高心肌梗死患者的治療。
公司磺達肝癸鈉注射液獲得國家藥監局的藥品註冊證書,標誌着公司具備了在國內市場銷售該藥品的資格,進一步豐富了公司的產品線,有助於提升公司產品的市場競爭力。
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