藥明巨諾-B(02126.HK)：倍諾達®上市許可申請獲受理 有望成為首個在中國批准用於治療r/r FL患者的細胞治療產品
格隆匯2月27日丨藥明巨諾-B(02126.HK)公佈，中國國家藥品監督管理局(“中國藥監局”)已受理其靶向CD19的自體嵌合抗原受體T(“CAR-T”)細胞免疫治療產品倍諾達®(瑞基奧侖賽注射液)用於治療復發或難治性(“r/r”)濾泡淋巴瘤(“FL”)患者的新適應症上市許可申請。這是藥明巨諾針對倍諾達®遞交的第二項上市許可申請，並且有望成為首個在中國批准用於治療r/r FL患者的細胞治療產品。此前，倍諾達®於2020年9月被中國藥監局授予治療r/r FL的突破性治療藥物認定。
此次新適應症上市申請基於一項將倍諾達®用於治療r/rB細胞非霍奇金淋巴瘤中國成人患者的單臂、多中心、關鍵性臨牀研究(“RELIANCE研究”)B隊列的研究結果，該研究結果已發佈於2021年12月第63屆美國血液學會(“ASH”)年會。RELIANCE研究B隊列結果顯示，倍諾達®展現了治療r/rFL極高且持續的疾病緩解率(3個月最佳完全緩解率和客觀緩解率分別為92.6%及100%)、以及可控的CAR-T治療相關毒性(任何級別的細胞因數釋放綜合徵(CRS)及神經毒性(NT)的發生率分別為42.9%及17.9%，≥3級CRS和NT的發生率分別為0%及3.6%)。
北京大學腫瘤醫院淋巴瘤科主任醫師、中國臨牀腫瘤學會理事宋玉琴教授在ASH年會上表示：“RELIANCE研究資料説明，倍諾達®在r/r FL患者中展現了出色的臨牀療效與安全性，我們期待倍諾達®通過新適應症上市審批。”
公吿顯示，倍諾達®(瑞基奧侖賽注射液)是藥明巨諾在巨諾醫療(一家百時美施貴寶的公司)的CAR-T細胞工藝平台的基礎上，自主開發的一款靶向CD19的自體CAR-T細胞免疫治療產品。作為藥明巨諾的首款產品，倍諾達®已於2021年9月被中國藥監局批准用於治療經過二線或以上系統性治療後成人患者的r/r大B細胞淋巴瘤(LBCL)，成為中國首個獲批為1類生物製品的CAR-T產品。倍諾達®是中國目前唯一一款同時獲得“重大新藥創制”專項、新藥上市申請優先審評資格、治療藥物及突破性治療藥物認定等三項殊榮的CAR-T細胞免疫治療產品。
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