海思科(002653.SZ)：獲得磺達肝癸鈉注射液的藥品註冊證書
格隆匯 12 月 21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(“遼寧海思科”)於近日收到國家藥品監督管理局下發的《藥品註冊證書》，藥品名稱為磺達肝癸鈉注射液。
本品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。
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，它具有生物利用度高、起效快、半衰期長等優點。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，不需監測PT(凝血酶原時間)、APTT(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，與血小板沒有相互作用，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。相比傳統抗凝藥物有很大的優勢。其不僅能夠減少心血管事件，而且降低了出血風險，在臨牀中表現出了良好的有效性和安全性，值得推廣應用。
本品直接接觸藥品的包裝材料採用預灌封注射器組合件(不帶注射針)，具儲存藥物和普通注射兩種作用，兼容性和穩定性良好的材料，不但安全可靠，而且減少了藥物轉移過程中造成的浪費和二次污染機會。
經查詢，磺達肝癸鈉注射液於2001年首次在美國上市，隨後分別於2002年、2007年在歐洲、日本上市，2018年和2019年江蘇恆瑞醫藥股份有限公司和博瑞製藥(蘇州)有限公司先後在國內上市，公司為國內該品種獲批企業第三家。
據米內網數據顯示，磺達肝癸鈉注射液2019年在中國城市公立醫院、縣級公立醫院終端銷售額約1.26億元人民幣。
據IMS數據顯示，磺達肝癸鈉注射液2019年全球銷售額約2.10億美元。
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