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四環醫藥(00460.HK):注射用醋酸卡泊芬淨獲藥品生產批件
格隆匯 06-16 17:23

格隆匯6月16日丨四環醫藥(00460.HK)宣佈,集團開發的注射用醋酸卡泊芬淨(50毫克)已於2021年6月獲得中華人民共和國國家藥品監督管理局頒發的《藥品註冊批件》,批准該藥品生產。

注射用醋酸卡泊芬淨為國家醫保目錄乙類藥品,是第一個新一代棘白菌素類廣譜抗真菌藥物,適用於成人患者和兒童患者(三個月及三個月以上)經驗性治療中性粒細胞減少、伴發熱病人的可疑真菌感染、念珠菌感染以及對其他治療無效或不能耐受的侵襲性麴黴菌病。

棘白菌素類抗真菌藥物是目前用於治療全身性真菌感染的一線藥物,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物。目前全球上市的棘白菌素類藥物主要有三種:卡泊芬淨、米卡芬淨和阿尼芬淨。卡泊芬淨因其更寬的抗菌譜以及更廣的用藥人羣,屬棘白菌素類抗真菌藥物中的佼佼者。據艾昆緯數據庫顯示,2019年注射用醋酸卡泊芬淨全球市場銷售額約為5.04億美元,中國市場銷售額約為1.46億美元。卡泊芬淨作為棘白菌素類抗真菌藥物中的佼佼者,其市場銷售預期仍有巨大增長空間。

抗感染領域為集團重點佈局領域,此次注射用醋酸卡泊芬淨(50毫克)獲頒《藥品註冊證書》批准生產上市,將進一步惠及廣大患者,同時為集團的抗感染藥物管線再添一重磅品種,利於該藥品未來的市場銷售和市場競爭,對集團的經營業績產生積極影響。

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