貝達藥業(300558.SZ):BPI-43487藥品臨牀試驗申請獲受理
格隆匯1月14日丨貝達藥業(300558.SZ)公佈,1月13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:CXHL2000010國、CXHL2000011國),公司申報的BPI-43487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。
產品名稱:BPI-43487膠囊;受理號:CXHL2000010國、CXHL2000011國;結論:根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。
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,是一種新型強效、高選擇性的成纖維細胞生長因子受體4(Fibroblastgrowth factor receptor 4,縮寫為FGFR4)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,縮寫為FGF19)擴增的肝細胞癌(Hepatocellularcarcinoma,縮寫為HCC)、膽管細胞癌等實體瘤的治療。
截至公告披露日,針對FGF19擴增的HCC患者治療的FGFR4抑制劑均處於早期臨牀階段,尚無藥物上市。根據原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-43487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-43487膠囊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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