貝達藥業(300558.SZ):在研新藥BPI-27336獲臨牀試驗通知書
格隆匯2月26日丨貝達藥業(300558.SZ)公佈,近日,公司收到了國家藥品監督管理局簽發的《臨牀試驗通知書》(文號:CXHL1900397、CXHL1900398),公司自主研發的BPI-27336片用於RAS/RAF/MEK激活變異的結直腸癌、胰腺癌、肺癌、肝癌、胃癌、黑色素瘤等實體瘤治療的藥品臨牀試驗申請已獲得國家藥品監督管理局批准。
BPI-27336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、選擇性的細胞外調節激酶1/2(Extracellular signalregulated-kinase, ERK1/2)口服小分子抑制劑,截至目前,全球範圍內尚無ERK1/2抑制劑上市,國外有若干ERK1/2抑制劑處於臨牀研究階段。
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