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復星醫藥(02196.HK):復星凱特獲CD19靶點自體CAR-T細胞治療產品FKC889臨牀試驗批准

格隆匯3月2日丨復星醫藥(02196.HK)公佈,近日,公司投資的復星凱特生物科技有限公司(截至本公吿日,公司控股子公司上海復星醫藥產業發展有限公司持有其50%股權;以下簡稱“復星凱特”)收到國家藥品監督管理局關於同意其CD19靶點自體CAR-T細胞治療產品FKC889(以下簡稱“該產品”)用於治療既往接受過二線及以上治療後復發或難治性套細胞淋巴瘤(r/rMCL)成人患者開展臨牀試驗的批准。復星凱特擬於條件具備後於中國境內(不包括港澳台,下同)開展針對該適應症的臨牀試驗。

該產品是由復星凱特根據美國Kite Pharma,Inc.(以下簡稱“Kite”,系GileadSciences,Inc.的控股子公司)的Brexucabtagene Autoleucel(商品名Tecartus)經技術轉移而本地化生產的CAR-T細胞治療產品,擬主要用於治療既往接受過二線及以上治療後復發或難治性套細胞淋巴瘤(r/rMCL)成人患者。2020年7月,Tecartus獲美國FDA(即美國食品藥品監督管理局)批准於美國上市。2020年12月,Tecartus獲歐洲EMA(即歐洲藥品管理局)批准於歐洲上市。

截至本公吿日,中國境內已上市的同靶點自體CAR-T細胞治療產品包括復星凱特的奕凱達(阿基侖賽注射液,2021年6月獲批上市)和上海藥明巨諾生物科技有限公司的倍諾達(瑞基奧侖賽注射液,2021年9月獲批上市)。截至2022年1月,復星凱特現階段針對該產品累計研發投入約為人民幣1,192萬元(未經審計)。

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