貝達藥業(300558.SZ):BPI-16350藥品聯用臨牀試驗申請獲得受理
格隆匯 4 月 6日丨貝達藥業(300558.SZ)公佈,近日,貝達藥業股份有限公司(以下簡稱"公司")收到國家藥品監督管理局簽發的《受理通知書》,公司申報的 BPI-16350 膠囊聯合氟維司羣或芳香化酶抑制劑治療乳腺癌的藥品臨牀試驗(以下簡稱"該臨牀試驗")申請已獲得國家藥品監督管理局受理。

BPI-16350是一個全新的、擁有完全自主知識產權的新分子實體化合物,由貝達藥業股份有限公司研發,針對的靶點為細胞週期蛋白依賴性激酶4/6(CDK4/6),擬單藥或與激素療法聯合,主要用於治療激素受體陽性和人類表皮生長因子受體2陰性(HR陽性/HER2陰性)的晚期或轉移乳腺癌患者,還可用於Rb+的其他癌症的一、二線或聯合治療。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,CDK4/6抑制劑將細胞週期阻滯於G1期,從而起到抑制腫瘤細胞增殖的作用。
BPI-16350於2018年獲得藥品審評中心的批准,已開展單藥用於晚期實本公司及董事會全體成員保證信息披露的內容真實、準確、完整,沒有虛假記載、誤導性陳述或重大遺漏。體瘤的臨牀試驗,目前Ⅰ期臨牀研究正在進行中。本次申請為BPI-16350聯合氟維司羣或芳香化酶抑制劑治療乳腺癌的臨牀試驗,系對BPI-16350應用的又一個探索。
截至本公吿日,全球共有四款 CDK4/6 獲批,即輝瑞公司的 Palbociclib
(Ibrance)、諾華公司的 Ribociclib(Kisqali)、禮來公司的 Abemaciclib
(Verzenio)以及 G1 的 Therapeutics(Cosela)。其中 Palbociclib 和 Abemaciclib
已在中國獲批。BPI-16350 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。
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