開拓藥業-B(09939.HK):計劃2021年上半年向國家藥監局提交普克魯胺的NDA申請
格隆匯 9 月 28日丨開拓藥業-B(09939.HK)發佈公告,集團正在中國開展多中心、隨機、雙盲、安慰劑對照的臨牀試驗,評估普克魯胺對進行阿比特龍及多西他賽治療後或對其不耐受的轉移性去勢抵抗性前列腺癌(“mCRPC”)患者的療效及安全性(“III期臨牀試驗”)。集團已於2018年7月3日建立具有統計、腫瘤學及臨牀專業知識的獨立數據監查委員會以評估從研究中收集的數據。集團於2018年9月開始招募患者,並於2020年8月完成招募。放射學無進展生存期(“rPFS”)及總生存時間(“OS”)是評估普克魯胺對mCRPC患者的療效及安全性的兩個主要終點且其中任何一個達到統計學意義均可用於向國家藥品監督管理局提交新藥申請(“NDA”)。集團最初計劃評估rPFS主要終點的中期分析結果(其獲取時間早於OS)以評定向國家藥監局提交的NDA,以實現普克魯胺的商業化。集團已於2020年9月完成rPFS事件的數據收集、分析及總結。
2020年9月20日,獨立數據監查委員會建議集團根據當前的試驗方案繼續進行研究,並收集進一步的OS數據。集團已考慮來自獨立數據監查委員會的建議,集團將繼續進行III期臨牀試驗,並計劃於2021年上半年根據第二個主要終點(OS)的最終分析向國家藥監局提交普克魯胺的NDA申請。
除上述披露外,集團目前預計普克魯胺或集團其他在研藥物的其他臨牀試驗的開發進展不會受到影響。
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