四環醫藥(00460.HK):軒竹生物創新藥XZP-3621獲批開展III期臨牀試驗
格隆匯10月25日丨四環醫藥(00460.HK)發佈公吿,集團旗下軒竹生物已收到國家藥品監督管理局藥品審評中心同意軒竹生物在研創新藥XZP-3621開展III期臨牀試驗的申請,具體適應症為ALK陽性晚期非小細胞肺癌(NSCLC),標誌着軒竹生物在非小細胞肺癌領域首個產品進入關鍵開發階段。
根據披露,XZP-3621為新一代ALK/ROS1雙靶點抑制劑,用於治療非小細胞肺癌。軒竹生物預計於近期啟動針對ALK陽性晚期非小細胞肺癌患者一線治療的III期臨牀試驗。臨牀研究結果表明,XZP-3621對ALK抑制劑初治和經治的ALK重排的晚期NSCLC患者均顯示有確切療效;具有更好的安全性,安全窗口高於一代及二代ALK抑制劑。臨牀前研究結果表明:體外研究結果顯示,XZP-3621對第一╱二代ALK抑制劑多個耐藥位點活性優異;體內藥效模型結果顯示藥效優於已上市藥物。XZP-3621在新一代ALK抑制劑中有望成為Best-inclass。
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