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恆瑞醫藥(600276.SH)子公司“注射用卡瑞利珠單抗”擬納入優先審評程序
格隆匯 09-03 15:49

格隆匯9月3日丨恆瑞醫藥(600276.SH)公佈,公司子公司蘇州盛迪亞生物醫藥有限公司的注射用卡瑞利珠單抗近日被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單,公示期7日。該藥品用於既往接受過二線及以上化療後疾病進展或不可耐受的晚期鼻咽癌患者的治療。

注射用卡瑞利珠單抗是人源化抗PD-1單克隆抗體,可與人PD-1受體結合並阻斷PD-1/PD-L1通路,恢復機體的抗腫瘤免疫力,從而形成癌症免疫治療基礎。經查詢,目前國外有3款PD-1單克隆抗體獲批上市,分別為帕博利珠單抗(默沙東,商品名可瑞達),納武利尤單抗(百時美施貴寶,商品名歐狄沃)和cemiplimab(再生元製藥,商品名Libtayo)。帕博利珠單抗和納武利尤單抗均已在國內獲批上市。

除恆瑞醫藥外,國內另有3款PD-1單克隆抗體獲批上市,分別為特瑞普利單抗(上海君實,商品名拓益,2018年獲批),信迪利單抗(信達生物,商品名達伯舒,2018年獲批)和替雷利珠單抗(百濟神州,商品名百澤安,2019年獲批)。經查詢,2019年抗PD-1抗體全球銷售額約為188.09億美元。截至目前,該產品累計已投入研發費用約為117,391萬元。

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