恆瑞醫藥(600276.SH)：SHR-3680-Ⅲ-HSPC研究雙主要終點均已達到
格隆匯5月24日丨恆瑞醫藥(600276.SH)公佈，近日，公司研發的SHR3680片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(研究編號：SHR-3680-Ⅲ-HSPC)，由獨立數據監察委員會(IDMC)判定主要研究終點總生存期(OS)的期中分析結果達到方案預設的優效標準。研究結果表明，SHR3680片可顯著延長高瘤負荷的mHSPC患者的總生存期。SHR3680片用於治療高瘤負荷的mHSPC已被國家藥品監督管理局藥品審評中心納入突破性治療品種名單，上市申請也已獲得優先審評資格。
SHR-3680-Ⅲ-HSPC研究是一項評估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家中心共同參與研究。該研究於2018年6月啟動，按照1:1隨機入組，共入組654例受試者。研究的主要終點包括無影像學進展生存期(rPFS，基於獨立評審委員會的評估)和OS，次要終點包括rPFS(基於研究者的評估)、至前列腺特異抗原進展時間和安全性等。2021年7月，該研究已完成主要終點rPFS的期中分析，IDMC判定rPFS期中分析結果達到方案預設的優效標準，此次OS期中分析結果同樣達到方案預設的優效標準，故目前該研究雙主要終點均已達到。
SHR3680是第二代AR抑制劑，相較於第一代AR抑制劑，具有更強的AR抑制作用，且無激動作用。目前全球已有比卡魯胺、恩扎盧胺等6個非甾體AR抑制劑上市，在中國有比卡魯胺、恩扎盧胺、阿帕他胺和達羅他胺等獲批上市。經查詢，2021年第二代AR抑制劑恩扎盧胺、阿帕他胺、達羅他胺全球銷售額合計約為62.97億美元。截至目前，SHR3680片相關項目累計已投入研發費用約3.56億元。
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