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恆瑞醫藥(600276.SH):藥品“SHR3680片”臨牀試驗取得進展
格隆匯 07-15 16:49

格隆匯7月15日丨恆瑞醫藥(600276.SH)公吿,近日,公司研發的SHR3680聯合雄激素剝奪療法(ADT)對比標準治療聯合ADT治療高瘤負荷的轉移性激素敏感性前列腺癌(mHSPC)的多中心、隨機、對照Ⅲ期臨牀研究,由獨立數據監察委員會(IDMC)判定主要研究終點無影像學進展生存期(rPFS)的期中分析結果達到方案預設的優效標準。該研究藥品名為SHR3680片”。

研究結果表明,SHR3680可顯著降低高瘤負荷的mHSPC患者的疾病進展或死亡風險。公司將於近期向國家藥品監督管理局藥品審評中心遞交上市前的溝通交流申請。

此項研究(SHR-3680-III-HSPC)是一項評估SHR3680聯合ADT對比標準治療聯合ADT治療高瘤負荷的mHSPC的多中心、隨機、對照Ⅲ期臨牀研究,由復旦大學附屬腫瘤醫院葉定偉教授擔任主要研究者,中國50家和東歐(波蘭、捷克和保加利亞)22家中心共同參研。

據悉,藥物需完成臨牀研究並經國家藥品監督管理局審評、審批通過後方可生產上市。

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