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藥明巨諾-B(02126.HK):倍諾達®針對二線不適合自體造血幹細胞移植成人復發或難治性大B細胞淋巴瘤的新適應症上市許可申請獲中國藥監局受理
格隆匯 05-28 16:40

格隆匯5月28日丨藥明巨諾-B(02126.HK)宣佈中國國家藥品監督管理局("NMPA")已受理其細胞免疫治療產品倍諾達®(瑞基奧侖賽注射液)用於二線治療復發或難治成人大B細胞淋巴瘤("r/r LBCL")患者的新適應症上市許可申請("sBLA")。這是藥明巨諾針對倍諾達®遞交的第四項上市許可申請。2025年1月,倍諾達®被NMPA授予二線治療r/r LBCL的突破性治療藥物認定。

大B細胞淋巴瘤("LBCL")是一種極具侵襲性的非霍奇金淋巴瘤,是成人最常見的淋巴瘤亞型。LBCL是一種可能被治癒的疾病,但一線治療後仍然有30–40%的患者出現難治或復發。一線治療失敗的LBCL患者預較差,傳統治療方案如高劑量化療序貫自體造血幹細胞移植("ASCT")雖為標準治療,但約一半以上患者因高齡、合併症等各種原因不適合ASCT。對此類患者,目前尚無標準治療,預極差,存在顯着未被滿足的臨牀需求,臨牀上仍急需開發安全有效的治療r/r LBCL的新方法。

本次sBLA是基一項將倍諾達®一線治療失敗不適合自體幹細胞移植的成人r/rLBCL的單臂、多中心、關鍵性臨牀研究的結果。這項在中國開展的2期單臂開放研究納入了接受過靶向CD20抗體和蒽環類一線系統治療失敗的且不適合ASCT的r/r LBCL患者。患者在清淋化療接受了100×106CAR+T細胞。截至2025年1月21日,已完成49例患者的回輸並完成了至少3個月的隨訪;基48例可進行療效評估的患者,瑞基奧侖賽展現了顯着的臨牀療效和良好的安全性,最佳客觀緩解率(ORR)為81.3%,最佳完全緩解率(CRR)為54.2%,重度(≥3級)的細胞因數釋放綜合徵(CRS)發生率為4.1%,無重度神經毒性(NT)發生。

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