福森藥業(01652.HK):恩扎盧胺軟膠囊上市許可申請獲得受理
格隆匯5月30日丨福森藥業(01652.HK)公吿,集團全資附屬公司嘉亨(珠海橫琴)醫藥科技有限公司研發的恩扎盧胺軟膠囊已向中國國家藥品監督管理局提交上市申請並獲受理。
恩扎盧胺軟膠囊用於以下疾病的治療:本品適用於有高危轉移風險的非轉移性去勢抵抗性前列腺癌(NM-CRPC)成年患者;雄激素剝奪治療(ADT)失敗後無症狀或有輕微症狀且未接受化療的轉移性去勢抵抗性前列腺癌(CRPC)成年患者的治療。前列腺癌是常見的泌尿系統惡性腫瘤,位居全球男性癌症發病率的第2位和癌症死亡率的第5位。我國前列腺癌的發病率低於西方國家,但近年來呈現上升的趨勢。
恩扎盧胺是一種雄激素受體抑制劑,作用於雄激素受體信號通路,可競爭性抑制雄激素與雄激素受體結合,進而抑制雄激素受體核移位以及雄激素受體與DNA的相互作用。恩扎盧胺主要代謝物N-去甲基–恩扎盧胺的體外活性與恩扎盧胺相似。恩扎盧胺在體外可抑制前列腺癌細胞增殖並誘導其死亡,且在小鼠前列腺癌移植瘤模型中可降低腫瘤體積。
恩扎盧胺2012年在美國上市,2013年在歐盟上市。2019年在中國批准上市。主要用於去勢抵抗性前列腺癌和轉移性去勢敏感性前列腺癌的治療。
恩扎盧胺軟膠囊是集團又一款重要產品,進一步豐富了集團在抗腫瘤治療領域的產品管線。該產品上市後將會為成人前列腺癌患者提供更多的治療選擇。
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