貝達藥業(300558.SZ)：BPI-27336藥品臨牀試驗申請獲受理
格隆匯12月4日丨貝達藥業(300558.SZ)公佈，12月4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：CXHL1900397國、CXHL1900398國)，公司申報的BPI-27336片的藥品臨牀試驗(“該臨牀試驗”)申請已獲得國家藥品監督管理局受理。
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(Extracellularsignal-regulated-kinase, ERK1/2)口服小分子抑制劑，擬用於RAS/RAF/MEK激活變異的結直腸癌、胰腺癌、肺癌、肝癌、胃癌、黑色素瘤等實體瘤的治療。
ERK1/2是絲裂原活化蛋白激酶(mitogen-activated protein kinases，MAPK)家族的重要成員，位於RAS/RAF/MEK/ERK通路下游。當RAS/RAF/MEK/ERK通路發生異常時，容易導致細胞生理功能障礙，甚至誘發癌變。作為RAS/RAF/MEK/ERK通路下游的“最終管理器”，靶向抑制ERK1/2有望用於治療MAPK通路異常激活(RAS/RAF/MEK等激活變異)造成的癌變，也可能對由於ERK1/2重新激活而產生RAF或MEK抑制劑耐藥的患者有效。
截至公告披露日，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。根據國家食品藥品監督管理總局發佈的化學藥品註冊分類改革工作方案的公告(2016年第51號)，BPI-27336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。
此次申請的臨牀試驗是BPI-27336片在晚期實體瘤患者中的Ⅰ期臨牀研究，在臨牀試驗申請獲得受理後，若在受理繳費之日起60日內未收到藥品審評中心的否定或質疑意見，公司便可以按照提交的方案開展臨牀試驗，在開展一系列臨牀試驗並經國家藥品監督管理局批准後方可上市，短期內對公司經營業績不會產生大的影響。
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