百濟神州(06160.HK)：歐洲藥品管理局已受理百澤安®用於治療食管鱗狀細胞癌和非小細胞肺癌的上市許可申請
格隆匯4月6日丨百濟神州(06160.HK)公吿，於2022年4月6日宣佈，百澤安®(替雷利珠單抗注射液)用於治療既往接受過全身化療的晚期或轉移性食管鱗狀細胞癌(ESCC)患者，以及非小細胞肺癌(NSCLC)患者的上市許可申請(MAA)已獲得歐洲藥品管理局(EMA)受理，目前正在審評中。該申請由百澤安歐洲許可持有人諾華提交。其中，針對NSCLC遞交的相關適應症包括：
單藥治療既往經化療後局部晚期或轉移性NSCLC的成人患者；作為一線療法，與卡鉑和紫杉醇(或白蛋白結合型紫杉醇)聯合用藥治療局部晚期或轉移性鱗狀NSCLC成人患者；作為一線療法，與培美曲塞和含鉑化療方案聯合用藥治療無EGFR或ALK陽性突變的局部晚期或轉移性非鱗狀NSCLC成人患者。
百澤安®(替雷利珠單抗注射液)是一款人源化IgG4抗程式性死亡受體1(PD-1)單克隆抗體，設計目的旨在最大限度地減少與巨噬細胞中的Fcγ受體結合。臨牀前資料表明，巨噬細胞中的Fcγ受體結合後會啟動抗體依賴細胞介導殺傷T細胞，從而降低了PD-1抗體的抗腫瘤活性。百澤安®是第一款由百濟神州的免疫腫瘤生物平台研發的藥物，目前正進行單藥及聯合療法臨牀試驗，以開發一系列針對實體瘤和血液腫瘤的廣泛適應症。
百濟神州高級副總裁、實體瘤首席醫學官Mark Lanasa醫學博士表示："公司在針對二線ESCC和NSCLC中進行的全球3期臨牀試驗中觀察到，百澤安®單藥顯著改善了患者的總生存期，並且在這些治療組中總體耐受性良好。在兩項針對一線NSCLC的3期研究中觀察到，相比化療，無論是鱗狀組織，還是非鱗狀組織，百澤安®聯合化療都顯示出顯著的無進展生存期改善，且耐受性良好，未出現新的安全性警示。此次百澤安®在EMA遞交首次上市申請是公司與諾華合作達成的又一里程碑事件，公司期待在雙方合作的地區中，共同拓展這一創新藥物的可及性。公司的團隊每天都在努力加快百澤安®的進展，致力於將這一重要的免疫治療新選擇帶給全球更多患者。"
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