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恆瑞醫藥(600276.SH):注射用醋酸卡泊芬淨國內首家通過一致性評價
格隆匯 05-31 16:23

格隆匯5月31日丨恆瑞醫藥(600276.SH)宣佈,公司近日收到國家藥監局核准簽發的關於注射用醋酸卡泊芬淨的《藥品補充申請批准通知書》,公司注射用醋酸卡泊芬淨通過仿製藥質量和療效一致性評價。

藥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;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的侵襲性麴黴菌病。

卡泊芬淨是一種可以抑制易感麴黴菌屬和念珠菌屬細胞壁基本成分β(1,3)-D-葡聚糖合成的棘白菌素。在哺乳動物細胞中不存在β(1,3)-D-葡聚糖。卡泊芬淨對念珠菌屬和煙麴黴菌菌絲的活性細胞生長部位有活性作用。

注射用醋酸卡泊芬淨最初由MERCK公司開發,2001年經美國食品藥品監督管理局批准在美國上市,商品名為Cancidas。截至目前,該藥品已在包括中國在內的多個國家上市銷售。除原研和恆瑞醫藥外,國內另有海南海靈化學、正大天晴藥業集團、遼寧海思科製藥、杭州中美華東製藥4家企業獲批生產,恆瑞醫藥為國內該藥通過仿製藥一致性評價的首家企業。

經查詢,2020年卡泊芬淨相關劑型全球銷售額約為4.54億美元。截至目前,注射用醋酸卡泊芬淨仿製藥一致性評價項目累計已投入研發費用約為658萬元。

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