海思科(002653.SZ):獲得注射用醋酸卡泊芬淨《藥品註冊證書》
格隆匯 8 月 17日丨海思科(002653.SZ)公佈,公司之全資子公司遼寧海思科製藥有限公司於近日收到國家食品藥品監督管理局下發的《藥品註冊證書》。
藥品名稱:注射用醋酸卡泊芬淨;適應症:本品適用於成人患者和兒童患者(三個月及三個月以上):1、經驗性治療中性粒細胞減少、伴發熱患者的可疑真菌感染;2、治療念珠菌血症和以下念珠菌感染:腹腔膿腫、腹膜炎和胸膜腔感染。尚未研究本品在由念珠菌感染引起的心內膜炎、骨髓炎和腦膜炎中的作用;3、治療食道念珠菌病;4、治療對其他治療無效或者不能耐受(例如:兩性黴素 B、兩性黴素 B 脂質體、伊曲康唑)患者的侵襲性麴黴菌病。尚未研究本品作為侵襲性麴黴菌病的初始治療的作用。
醋酸卡泊芬淨是一種由Glarea Lozoyensis發酵產物合成而來的半合成脂肽(棘白菌素)化合物,是第一個棘白黴素類新型抗真菌藥物。具有抗菌譜廣、半衰期較長、與人血清蛋白結合率高、不良反應較少、患者耐受性好等特點,是臨牀急需的抗深部真菌感染藥。
經查詢,2001年美國FDA批准Merck&Co.,Inc(默克)的注射用醋酸卡泊芬淨(Cancidas®,50mg和70mg)上市,2007年SFDA批准Merck Sharp & Dohme Corp(默沙東)的科賽斯?進口,規格50mg和70mg。我公司為國內同品種第4家。
米內網數據顯示,該產品2019年在中國城市公立醫院、縣級公立醫院、城市社區中心及鄉鎮衞生院終端銷售額超過20億元。
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