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復星醫藥(02196.HK):益基利侖賽注射液獲納入藥品上市註冊優先審評程序
格隆匯 03-15 20:08

格隆匯3月15日丨復星醫藥(02196.HK)公告,根據國家藥品監督管理局(以下簡稱“國家藥監局”)藥品審評中心發佈的公示信息,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)投資的合營公司復星凱特生物科技有限公司(截至本公告日,本公司全資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”)的益基利侖賽注射液(擬定)(代號FKC876,即抗人CD19CAR-T細胞注射液,以下簡稱“該產品”)已納入藥品上市註冊優先審評程序。

該產品是根據美國Kite Pharma,Inc.(以下簡稱“KitePharma”,系GileadSciences,Inc.的控股子公司)的抗人CD19CAR-T細胞注射液(商品名YESCARTA)經技術轉移而本地化生產,主要用於復發難治性成人大B細胞淋巴瘤(包括瀰漫性大B細胞淋巴瘤(DLBCL)非特指型、原發性縱隔B細胞淋巴瘤(PMBCL)、高級別B細胞淋巴瘤和濾泡淋巴瘤轉化的DLBCL)的治療。

2017年10月,YESCARTA獲美國FDA(即美國食品藥品監督管理局)批准於美國上市,是美國FDA批准的首款針對特定非霍奇金淋巴瘤的CAR-T細胞藥物。2018年8月,YESCARTA獲歐洲EMA(即歐洲藥品管理局)批准於歐洲上市。該產品由復星凱特從KitePharma引進、獲得在中國大陸、香港特別行政區和澳門特別行政區的技術及商業化權利,並擬於中國境內(不包括港澳台地區,下同)進行本地化生產。

2018年8月,該產品獲得國家藥監局臨牀試驗批准。截至本公告日,該產品已完成用於治療成人復發難治性大B細胞淋巴瘤的中國境內橋接臨牀試驗,其上市註冊申請已獲國家藥監局審評受理。

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