貝達藥業(300558.SZ):BPI-23314片用於晚期惡性實體瘤的藥品臨牀試驗申請已取得批准
格隆匯 1 月 14日丨貝達藥業(300558.SZ)公佈,近日,公司收到國家藥品監督管理局籤發的《藥物臨牀試驗批准通知書》(通知書編號:2021LP00032),公司申報的BPI-23314片用於晚期惡性實體瘤的藥品臨牀試驗申請已取得國家藥品監督管理局批准。
BPI-23314是一個由貝達藥業自主研發的擁有完全自主知識產權的新分子實體化合物,是一種新型強效、選擇性的溴結構域和末端外結構域(Bromodomain and extra-terminal domain, BET)蛋白家族的口服小分子抑制劑,具有全新的降解靶點蛋白的作用機制,擬用於血液瘤、乳腺癌以及肺癌等腫瘤的治療。
BPI-23314已於2019年3月獲得CDE批准,開展單藥用於惡性血液系統腫瘤的臨牀試驗,目前I期臨牀研究正在進行中。2020年10月,公司向國家藥品監督管理局遞交了BPI-23314針對實體瘤患者的藥品臨牀試驗申請並獲受理,相關具體情況詳見公司於2020年11月12日披露的《關於BPI-23314藥品臨牀試驗申請獲得受理的公吿》(公吿編號:2020-131)。
截至公吿披露日,國內外同靶點藥物均處於臨牀試驗階段,尚無藥物上市。BPI-23314屬於“境內外均未上市的創新藥”,其註冊分類為化學藥品1類。
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