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首藥控股(688197.SH):SY-3505是目前公司第一優先梯隊的品種
格隆匯 06-06 09:41

格隆匯6月6日丨有投資者向首藥控股(688197.SH)提問:公司第三代ALK抑制劑SY-3505在今年的3月取得了附條件批准上市的資質。公司能否給我們分享一下後續關鍵臨牀的入組進度、今年可能會看到的研發里程碑,以及後續的數據更新計劃。

首藥控股回覆:SY-3505是目前公司第一優先梯隊的品種,我們會集中資源優先推進其關鍵性臨牀試驗。今年4月,我們取得了組長單位中國醫學科學院腫瘤醫院倫理批件,目前正在國內積極啟動多家研究中心,預計本月首例病人入組。根據試驗設計方案,關鍵性Ⅱ期臨牀是單臂試驗,我們會加速推進患者招募和跟蹤工作,做好質量管控,希望明年能有進一步的數據讀出,並爭取在重要學術會議上和大家分享。

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