藥明巨諾-B(02126.HK):倍諾達®在中國被授予治療套細胞淋巴瘤的突破性治療藥物認定
格隆匯4月3日丨藥明巨諾-B(02126.HK)發佈公吿,中國國家藥品監督管理局藥品審評中心已授予倍諾達® (瑞基奧侖賽注射液)用於治療套細胞淋巴瘤(“MCL”)的突破性治療藥物認定。倍諾達®是藥明巨諾自主開發的一款靶向CD19的自體嵌合抗原受體T(“CAR-T”)細胞免疫治療產品。
該突破性治療藥物認定基於一項旨在評估倍諾達®治療中國復發或難治性套細胞淋巴瘤(“r/r MCL”)成年受試者的有效性和安全性研究的臨牀資料支援,這是首次基於中國患者獲得的臨牀試驗資料。
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