中國生物製藥(01177.HK):1類創新藥庫莫西利膠囊“Culmerciclib(TQB3616)”新藥上市申請獲得受理
格隆匯7月18日丨中國生物製藥(01177.HK)發佈公吿,集團開發的1類創新藥庫莫西利膠囊“Culmerciclib(TQB3616)”聯合氟維司羣注射液用於既往內分泌經治的激素受體(HR)陽性、人表皮生長因子受體2(HER2)陰性局部晚期或轉移性乳腺癌的III期臨牀試驗(NCT05375461)已完成期中分析,經獨立數據監查委員會(IDMC)審核,達到預設的主要終點,研究結果將在學術期刊或重大學術會議上予以公佈。集團已向中國國家藥品監督管理局藥品審評中心(CDE)遞交新藥上市申請並獲受理。
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