信達生物(01801.HK):伊匹木單抗注射液聯合信迪利單抗用於結腸癌新輔助治療的新藥上市申請獲國家藥監局受理並納入優先審評
格隆匯2月24日丨信達生物(01801.HK)發佈公告,伊匹木單抗注射液(抗細胞毒T淋巴細胞相關抗原4(“CTLA-4”單抗,研發代號:IBI310)聯合信迪利單抗用於可切除的微衛星高度不穩定型(“MSI-H”)或錯配修復缺陷型(“dMMR”)結腸癌患者的新輔助治療的新藥上市申請(“NDA”)已獲中國國家藥品監督管理局(“NMPA”)藥品審評中心(“CDE”)受理並納入優先審評程序。伊匹木單抗是首個遞交NDA的中國研發的CTLA-4單抗,同時,這也是信迪利單抗奠定其腫瘤免疫治療領先品牌的又一里程碑。
此次NDA獲受理並納入優先審評是基於一項在中國開展的隨機、對照、多中心、 III期註冊研究(NeoShot,NCT05890742)的結果。研究旨在評估伊匹木單抗聯合信迪利單抗新輔助治療可切除的MSI-H/dMMR結腸癌對比直接根治性手術的有效性和安全性。研究的主要終點爲病理完全緩解率(“pCR”)和無事件生存期 (EFS)。NeoShot研究期中分析顯示,經獨立數據監查委員會(IDMC)評估達到了預設的主要研究終點,相關研究結果計劃在未來的學術大會或學術期刊上發表。
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