貝達藥業(300558.SZ)：PD-1抗體和CTLA-4抗體聯用治療晚期實體瘤獲批臨牀試驗
格隆匯7月15日丨貝達藥業(300558.SZ)公佈，今日，公司收到國家藥品監督管理局(“NMPA”)籤發的《藥物臨牀試驗批准通知書》(通知書編號：2021LP01044、2021LP01052)，公司和AgenusInc. (NASDAQ: AGEN，“Agenus”)共同申報的評價巴替利單抗注射液(Balstilimab，PD-1抗體)和澤弗利單抗注射液(Zalifrelimab，CTLA-4抗體)聯用治療晚期實體瘤的兩項藥品臨牀試驗已獲NMPA批准開展。
巴替利單抗注射液是一種免疫檢查點抑制劑，是靶向於T細胞上的程序性死亡受體1(PD-1)的全人源單克隆抗體。澤弗利單抗注射液是一種靶向於T細胞表面表達的細胞毒性T淋巴細胞相關抗原4(CTLA-4)的全人源單克隆抗體。通過與Agenus的戰略合作，公司取得了巴替利單抗和澤弗利單抗在中國(包括香港、澳門和台灣)區域內單藥或聯用(包括聯合其它藥物)治療除膀胱內給藥外的所有腫瘤學和非腫瘤學適應症的獨家權利。巴替利單抗和澤弗利單抗是公司研發管線的重要補充，有助於公司探索開發管線產品的聯用治療方案。
2021年4月，Agenus完成向美國食品藥品監督管理局(FDA)滾動遞交的巴替利單抗治療複發性或轉移性宮頸癌的生物製品上市申請(BLA)。2021年6月，Agenus的該BLA獲得FDA受理和優先審評。公司已於2021年6月取得NMPA關於巴替利單抗注射液單獨或聯合澤弗利單抗注射液治療晚期宮頸癌臨牀試驗方案的《藥物臨牀試驗批准通知書》。
截至公吿日，中國區域有8款PD-1/PD-L1產品獲批上市，包括納武利尤單抗、帕博利珠單抗、特瑞普利單抗、信迪利單抗、卡瑞利珠單抗、替雷利珠單抗、阿替利珠單抗以及度伐利尤單抗，獲批的適應症包括經典型霍奇金淋巴瘤、黑色素瘤、非小細胞肺癌、食道癌、肝細胞癌、頭頸部鱗癌和尿路上皮癌等；中國區域有1款CTLA-4產品獲批上市，為伊匹木單抗，獲批的適應症為胸膜間皮瘤。
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