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貝達藥業(300558.SZ):在研新藥BPI-43487臨牀試驗獲批
格隆匯 12-14 20:28

格隆匯 12 月 14日丨貝達藥業(300558.SZ)公佈,今日,公司收到國家藥品監督管理局簽發的《藥物臨牀試驗批准通知書》(通知書編號:2020LP00879、2020LP00880),公司自主研發的成纖維細胞生長因子受體4(Fibroblast growth factor receptor 4,FGFR4)口服小分子抑制劑BPI-43487膠囊的藥品臨牀試驗申請已取得國家藥品監督管理局批准。

BPI-43487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,是一種強效、高選擇性的FGFR4共價非可逆口服小分子抑制劑,擬用於成纖維細胞生長因子19(Fibroblast growth factor-19,FGF19)擴增的肝細胞癌(Hepatocellular carcinoma,HCC)、膽管細胞癌等實體瘤的治療。2020年1月,公司向國家藥品監督管理局遞交了BPI-43487的藥品臨牀試驗申請並獲受理。

截至公告披露日,針對FGF19擴增或FGFR4過表達的HCC患者治療的FGFR4抑制劑均處於臨牀開發階段,尚無藥物上市。

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