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貝達藥業(300558.SZ):BPI-16350藥品註冊申請獲得受理
格隆匯 05-06 16:14

格隆匯5月6日丨貝達藥業(300558.SZ)公佈,近日,貝達藥業股份有限公司收到國家藥品監督管理局(簡稱“NMPA”)簽發的《受理通知書》(受理號:CXHS2400039),公司申報的BPI-16350(酒石酸泰貝西利膠囊)“本品聯合氟維司羣,適用於既往接受內分泌治療後進展的激素受體(HR)陽性、人表皮生長因子受體2(HER2)陰性的局部晚期或晚期復發轉移性乳腺癌患者的治療”的上市許可申請已獲得NMPA受理。

BPI-16350是由公司自主研發的全新的、擁有完全自主知識產權的新分子實體化合物,針對的靶點為細胞週期蛋白依賴性激酶4/6(CDK4/6)。CDK4/6是調節細胞週期的關鍵因子,能夠觸發細胞週期從生長期(G1期)向DNA複製期(S期)轉變,BPI-16350能特異性地和CDK4/6結合而抑制其激酶活性,抑制癌細胞增殖、轉移等相關的信號傳導,將細胞週期阻滯於G1期,從而起到抑制腫瘤細胞增殖的作用。本次申報的適應症是BPI-16350聯合氟維司羣適用於既往接受內分泌治療後進展的HR+/HER2-的局部晚期或晚期復發轉移性乳腺癌患者的治療。

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