李氏大藥廠(00950.HK)磺達肝癸鈉注射液獲國家藥監局上市批文
格隆匯2月5日丨李氏大藥廠(00950.HK)公吿,於2021年2月2日,由公司全資附屬公司兆科藥業(合肥)有限公司開發的磺達肝癸鈉注射液(0.5毫升:2.5毫克)已獲中國國家藥品監督管理局的生產及上市批文。該藥物適用於預防正進行髖關節手術、髖關節或膝關節置換或下腹手術的人士出現可導致肺栓塞(PE;肺部血凝塊)的深靜脈血栓(DVT;一般見於腿部的血凝塊)。
磺達肝癸鈉乃人工合成的活化凝血X因子(Xa因子)選擇性抑制劑,具有生物利用度高、起效快、半衰期長等優點。磺達肝癸鈉對Ⅱa因子無作用,出血的不良反應少,僅抑制遊離的Xa因子而不抑制與凝血酶原酶結合的Xa因子,不需監測PT(凝血酶原時間)及aPTT(活化部分凝血酶原時間)。磺達肝癸鈉分子鏈短,不能誘導抗體反應,與血小板並無相互作用,不會引起血小板減少症,且對肝臟無毒害作用,過敏反應發生少。磺達肝癸鈉相比傳統抗凝藥物優勢很大,市場潛力龐大。
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