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復星醫藥(600196.SH):阿基侖賽注射液已被納入突破性治療藥物程序
格隆匯 08-17 17:14

格隆匯8月17日丨復星醫藥(600196.SH)公佈,根據國家藥監局藥品審評中心發佈的公示信息,公司投資的復星凱特生物科技有限公司(截至公吿日,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;“復星凱特”)的阿基侖賽注射液(商品名:奕凱達®,“該產品”)用於治療接受過二線或以上系統治療後復發或難治性惰性非霍奇金淋巴瘤(r/riNHL),包含濾泡性淋巴瘤(FL)和邊緣區淋巴瘤(MZL)已被納入突破性治療藥物程序。

該產品系復星凱特基於從Kite Pharma引進的CAR-T細胞治療產品Yescarta行技術轉移並獲授權在中國進行本地化生產的細胞治療產品。2021610日,該產品用於治療接受過二線或以上系統治療後復發或難治性惰性非霍奇金淋巴瘤(r/r iNHL),包含濾泡性淋巴瘤(FL)和邊緣區淋巴瘤(MZL)獲國家藥監局臨牀試驗批准2021622,該產品用於治療既往接受二線或以上系統性治療後復發或難治性大B細胞淋巴瘤成人患者,包括瀰漫性大B細胞淋巴瘤(DLBCL)非特指型(NOS),原發縱膈大 B 細胞淋巴瘤(PMBCL)、高級別B細胞淋巴瘤和濾泡性淋巴瘤轉化的DLBCL獲國家藥監局上市批准 截至公吿日,除奕凱達®外,中國境內尚無其他CAR-T細胞治療產品獲批上市。

截至20217月,復星凱特現階段針對該產品累計研發投入約人民幣70354萬元(含專利及技術許可費用,未經審計)。

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