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中國生物製藥(01177.HK):庫莫西利膠囊一線治療乳腺癌新適應症上市申請獲得受理
格隆匯 07-10 16:40

格隆匯7月10日丨中國生物製藥(01177.HK)宣佈,集團自主研發的CDK2/4/6抑制劑庫莫西利膠囊"TQB3616"聯合氟維司羣注射液用於既往未經治療的HR陽性、HER2陰性(HR+/HER2-)局部晚期或轉移性乳腺癌,已向中國國家藥品監督管理局藥品審評中心("CDE")提交新適應症上市申請,並獲得受理。

TQB3616-III-02(NCT04523272)是一項隨機、雙盲、平行對照、多中心III期臨牀研究,旨在評價TQB3616聯合氟維司羣對比安慰劑聯合氟維司羣在既往未經治療的HR+/HER2-晚期乳腺癌患者中的有效性和安全性。該研究已達到主要終點,詳細數據將近期開展的國際權威學術大會公佈。

乳腺癌是女性最常見的惡性腫瘤之一。其中,HR+/HER2-乳腺癌約佔全部乳腺癌的65%-70%,是乳腺癌最常見的亞型。約4%-6%的乳腺癌患者初診即晚期,而早期患者即使接受標準輔助治療,仍有30%-40%進展成爲晚期。《中國臨牀腫瘤學會(CSCO)乳腺癌指南(2025版)》等權威指南一致推薦CDK4/6抑制劑聯合內分泌治療用HR+/HER2-晚期乳腺癌一線治療。

集團已於2024年7月遞交庫莫西利的新藥上市申請,並獲CDE受理,用於聯合氟維司羣治療既往內分泌經治的HR+/HER2-局部晚期或轉移性乳腺癌。此次一線適應症上市申請再獲受理,進一步證實了該聯合療法在晚期乳腺癌不同治療階段的廣闊潛力。

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