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先聲藥業(02096.HK):曲拉西利用於廣泛期小細胞肺癌骨髓保護的III期臨牀達到主要研究終點
格隆匯 02-23 20:44

格隆匯2月23日丨先聲藥業(02096.HK)公吿,注射用曲拉西利(Trilaciclib)在接受卡鉑聯合依託泊苷或拓撲替康治療的廣泛期小細胞肺癌(ES-SCLC)患者中的安全性、有效性和藥代動力學特徵的隨機雙盲、安慰劑對照、多中心III期臨牀研究(研究代號:TRACES)達主要臨牀終點。基於頂線數據的評估,相對於安慰劑組,注射用曲拉西利顯著降低了第1週期嚴重中性粒細胞減少的持續時間(DSN)。相關研究結果未來將在學術會議上予以公佈。

注射用曲拉西利(一種細胞週期蛋白依賴性激酶CDK4/6抑制劑)是集團與G1 Therapeutics,INC.合作的創新藥。2020年8月,集團與G1公司達成獨家授權合約,獲得注射用曲拉西利在大中華地區所有適應症的開發和商業化權益。2021年11月29日,中國國家藥品監督管理局("NMPA")受理注射用曲拉西利的境外生產藥品註冊上市許可申請(NDA)。2021年12月22日,NMPA藥品審評中心("CDE")將該產品納入優先審評品種。

G1是一家商業階段的生物製藥公司,專注於發現、開發和交付旨在改善癌症患者生活的下一代療法。

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