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貝達藥業(300558.SZ):BPI-421286膠囊藥品臨牀試驗申請獲受理
格隆匯 01-21 20:06

格隆匯1月21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簽發的《受理通知書》(受理號:CXHL2100046國;CXHL2100047國),公司申報的BPI-421286膠囊的藥品臨牀試驗申請已獲得國家藥品監督管理局受理。

BPI-421286是一個全新的、擁有完全自主知識產權的新分子實體化合物,由貝達藥業股份有限公司開發,是一種新型強效、高選擇性的共價不可逆KRASG12C口服小分子抑制劑,擬用於攜帶KRASG12C特異性致癌基因突變的不可切除、局部晚期或轉移性實體瘤患者的治療。

臨牀前數據顯示,BPI-421286體內外生物學活性一致,能有效抑制攜帶KRASG12C突變腫瘤細胞的增殖,並在多種攜帶KRASG12C突變的移植瘤模型上展現了良好的抗腫瘤作用。BPI-421286有望提供一種新的分子靶向的治療方法,為攜帶KRASG12C突變的患者提供更多益處。

截至公吿披露日,國內外該靶點所有藥物均處於臨牀階段,尚無藥物上市。BPI-421286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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