百濟神州(688235.SH)：百澤安®(替雷利珠單抗注射液)新適應症上市許可申請獲EMA受理
格隆匯4月6日丨百濟神州(688235.SH)公佈，公司近日收到歐洲藥品管理局(簡稱“EMA”)的通知，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患者，以及非小細胞肺癌患者的新適應症上市許可申請獲得受理。該項新適應症上市許可申請由百澤安®歐洲許可持有人Novartis(簡稱“諾華”)提交。
該藥品適應症：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。其中，針對NSCLC遞交申請的相關適應症包括：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抗程序性死亡受體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。臨牀前數據表明，巨噬細胞中的Fcγ受體結合之後會激活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®是第一款由公司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。
此次向EMA申報百澤安®用於治療ESCC的新適應症上市許可申請是基於一項隨機、開放性、多中心的全球3期試驗RATIONALE302(NCT03430843)的結果，該試驗旨在評價百澤安®相比研究者選擇的化療方案用於晚期或轉移性ESCC患者二線治療的有效性和安全性。遞交資料中還包括在7項臨牀試驗中1972例接受百澤安®單藥治療患者的安全性數據。
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