貝達藥業(300558.SZ):BPI-16350獲藥品聯用臨牀試驗批准通知書
格隆匯6月17日丨貝達藥業(300558.SZ)公佈,今日,公司收到國家藥品監督管理局簽發的《藥品臨牀試驗批准通知書》(通知書編號:2021LP00866、2021LP00867),公司申報的BPI-16350膠囊聯合非甾體類芳香化酶抑制劑(來曲唑/阿那曲唑)或氟維司羣治療激素受體陽性、人類表皮生長因子受體2陰性(HR陽性/HER2陰性)晚期乳腺癌的Ib/II期臨牀試驗申請已獲國家藥品監督管理局批准開展。
審評結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年3月31日受理的BPI-16350膠囊符合藥品註冊的有關要求,同意開展用於乳腺癌治療的臨牀試驗,具體為:BPI-16350膠囊聯合非甾體類芳香化酶抑制劑(來曲唑/阿那曲唑)或氟維司羣治療激素受體陽性、HER2陰性晚期乳腺癌的Ib/II期臨牀研究。
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,由公司自主研發,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HR陽性/HER2陰性的晚期或轉移乳腺癌患者,還可能用於Rb+的其他癌症的一、二線或聯合治療。
截至公吿日,全球共有四款CDK4/6抑制劑獲批,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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