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信達生物(01801.HK):NMPA受理達伯舒®用於治療中國國內二線鱗狀非小細胞肺癌患者的新適應症申請
格隆匯 01-12 12:34

格隆匯1月12日丨信達生物(01801.HK)宣佈,集團與禮來製藥共同開發的創新PD-1抑制劑達伯舒®(信迪利單抗注射液)用於治療二線鱗狀非小細胞肺癌(“NSCLC”)的新適應症申請(該“sNDA”)獲國家藥品監督管理局(“NMPA”)受理。此次申請為達伯舒®(信迪利單抗注射液)在NSCLC領域的第3項sNDA。

該sNDA乃基於一項隨機、開放式標籤、3期臨牀試驗(ORIENT-3)-研究評估達伯舒®(信迪利單抗注射液)用於一線鉑類化療失敗的晚期或複發性NSCLC二線治療。最終分析結果顯示,達伯舒®(信迪利單抗注射液)對比多西他賽,顯著延長了總生存期(“OS”),達到預設的優效性標準;無進展生存期(“PFS”)和客觀緩解率(“ORR”)也均有顯著提高。安全性特徵與既往報道的信迪利單抗研究結果一致,無新的安全性信號。詳細的研究數據將在近期的國際學術會議和學術期刊中公佈。

肺癌是中國目前發病率和死亡率均排名第一的惡性腫瘤。在所有肺癌中NSCLC約佔80%至85%,約70%的NSCLC患者在初診時已是不適進行根治性切除手術的局部晚期或轉移性腫瘤。同時,該等患者在接受根治性切除手術治療後仍有相當高的複發率,最終死於疾病進展。中國NSCLC患者中約30%為鱗狀NSCLC,該等患者在二線免疫治療藥物的選擇非常有限,中國國內目前仍存在龐大的醫療需求。

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