恆瑞醫藥(600276.SH)：注射用卡瑞利珠單抗獲藥品註冊證書 涉及增加適應症
格隆匯12月13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近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》，藥品名稱為注射用卡瑞利珠單抗。
審批結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，本品符合藥品註冊的有關要求，批准本品增加適應症，具體為“本品聯合紫杉醇和順鉑用於不可切除局部晚期/復發或轉移性食管鱗癌患者的一線治療”。
根據《中華人民共和國藥品管理法》及有關規定，經審查，本品符合藥品註冊的有關要求，批准本品增加適應症，具體為“本品聯合紫杉醇和卡鉑用於局部晚期或轉移性鱗狀非小細胞肺癌患者的一線治療”。
2019年5月，公司的注射用卡瑞利珠單抗(商品名：艾瑞卡)獲批用於至少經過二線系統化療的復發或難治性經典型霍奇金淋巴瘤的治療；2020年3月，獲批用於既往接受過索拉非尼治療和/或含奧沙利鉑系統化療的晚期肝細胞癌患者的治療；2020年6月，獲批聯合培美曲塞和卡鉑適用於表皮生長因子受體(EGFR)基因突變陰性和間變性淋巴瘤激酶(ALK)陰性的、不可手術切除的局部晚期或轉移性非鱗狀非小細胞肺癌(NSCLC)的一線治療，和用於既往接受過一線化療後疾病進展或不可耐受的局部晚期或轉移性食管鱗癌患者的治療；2021年5月，獲批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；2021年6月，獲批聯合順鉑和吉西他濱用於局部復發或轉移性鼻咽癌患者的一線治療。
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。國外有4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)、cemiplimab(再生元製藥，商品名Libtayo)和dostarlimab(葛蘭素史克，商品名Jemperli)，帕博利珠單抗和納武利尤單抗均已在國內獲批上市。除恆瑞醫藥的注射用卡瑞利珠單抗外，國內另有5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)、替雷利珠單抗(百濟神州，商品名百澤安，2019年獲批)、派安普利單抗注射液(正大天晴和康方生物，商品名安尼可，2021年獲批)和賽帕利單抗注射液(譽衡生物，商品名譽妥，2021年獲批)。經查詢EvaluatePharma數據庫，2020年抗PD-1抗體全球銷售額約237.6億美元。截至目前，注射用卡瑞利珠單抗相關項目累計已投入研發費用約17.899億元。
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