恆瑞醫藥(600276.SH):注射用卡瑞利珠單抗獲批臨牀試驗
格隆匯 7 月 20日丨恆瑞醫藥(600276.SH)公佈,公司及子公司蘇州盛迪亞生物醫藥有限公司、上海恆瑞醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗,藥品名稱為注射用卡瑞利珠單抗。
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IQVIA數據庫,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105725萬元。
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