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華東醫藥(000963.SZ):中美華東注射用米卡芬淨鈉獲批上市
格隆匯 06-18 16:45

格隆匯6月18日丨華東醫藥(000963.SZ)公佈,近日,公司全資子公司中美華東收到國家藥監局核准簽發的關於注射用米卡芬淨鈉(50mg)的《藥品註冊證書》(證書編號:2021S00603)。

米卡芬淨鈉是美國感染病學會(IDSA)念珠菌病臨牀實踐指南(2016版)推薦一線用藥,是繼卡泊芬淨之後全球第二個獲批上市的棘白菌素類抗真菌藥物,作用機制獨特,副作用小,抗菌譜廣,有效覆蓋臨牀常見念珠菌以及麴黴菌,可用於血液病/惡性腫瘤患者侵襲性真菌感染的各個環節,能應用於ICU搶救中發生的大規模真菌感染。臨牀研究結果表明,在同類產品中,米卡芬淨鈉安全性良好,對肝腎功能不全患者及兒童、老年人無需調整劑量,並可與免疫抑制劑等多種藥物聯用,極少出現藥物間相互作用,且價格相對低廉,市場潛力大。該藥物原研廠家為安斯泰來(Astellas),於2002年在日本上市,2005年獲得FDA批准,2007年在中國獲批上市。

截至目前,除原研企業外,國內共有六家企業(含中美華東)取得了米卡芬淨鈉藥品註冊證書。經IQVIA數據庫查詢,該產品2020年全球銷售額為3.36億美元。

截至該公吿日,公司注射用米卡芬淨鈉累計直接的研發投入約為人民幣3859萬元。

公司超級抗生素領域產品達託黴素於2015年上市銷售,注射用醋酸卡泊芬淨於2020年11月獲批上市,該次注射用米卡芬淨鈉獲批上市,成為公司第三個獲批的超抗產品,將進一步完善公司在超抗領域的產品結構,與公司現有超抗領域上市品種形成協同效應,有利於提升公司在該領域的市場競爭力,對公司未來業績提升有一定積極作用。

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