恆瑞醫藥(600276.SH)：甲磺酸阿帕替尼片、注射用卡瑞利珠單抗獲批開展臨牀試驗
格隆匯1月7日丨恆瑞醫藥(600276.SH)公佈，近日，公司及子公司蘇州盛迪亞生物醫藥有限公司收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發關於甲磺酸阿帕替尼片、注射用卡瑞利珠單抗的《藥物臨牀試驗批准通知書》，將於近期開展臨牀試驗。
甲磺酸阿帕替尼片是公司創新研發的小分子靶向藥物，經查詢，國內外有索拉非尼、舒尼替尼、培唑帕尼等多種同類產品獲批上市。索拉非尼由拜耳公司開發，2005年在美國獲批上市；舒尼替尼由輝瑞公司開發，2006年在美國獲批上市；培唑帕尼由諾華研發，2009年在美國獲批上市。索拉非尼、舒尼替尼、培唑帕尼均已在國內上市。經查詢EvaluatePharma數據庫，2020年索拉非尼、舒尼替尼和培唑帕尼全球銷售額合計約為21.83億美元。截至目前，甲磺酸阿帕替尼相關項目累計已投入研發費用約40478萬元。
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抗體全球銷售額約為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187406萬元。
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