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貝達藥業(300558.SZ):巴替利單抗注射液治療宮頸癌在中國獲批臨牀
格隆匯 06-10 19:09

格隆匯6月10日丨貝達藥業(300558.SZ)宣佈,今日,公司收到國家藥監局(簡稱“NMPA”)簽發的《藥物臨牀試驗批准通知書》(通知書編號:2021LP00858),公司和Agenus Inc.(NASDAQ:AGEN,簡稱“Agenus”)共同申報的評價巴替利單抗注射液(Balstilimab,PD-1抗體)單獨或聯合澤弗利單抗注射液(Zalifrelimab,CTLA-4抗體)治療晚期宮頸癌的臨牀試驗已獲NMPA批准開展。

巴替利單抗注射液是一款免疫檢查點抑制劑,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。通過與Agenus的戰略合作,公司擁有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。

目前,中國區域內共有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。巴替利單抗屬於“未在國內外上市銷售的生物製品”,其註冊分類為治療用生物製品1類。

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