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復星醫藥(02196.HK):復星凱特奕凱達上市註冊申請獲國家藥監局批准
格隆匯 06-23 19:36

格隆匯6月23日丨復星醫藥(02196.HK)公佈,2021年6月23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頒發的《藥品註冊證書》,其CD19靶點自體CAR-T細胞治療產品阿基侖賽注射液(產品代號FKC876,商品名稱:奕凱達)的上市註冊申請獲國家藥監局批准。

該產品為經基因修飾的靶向人CD19的嵌合抗原受體自體T(CAR-T)細胞,主要用於治療特定非霍奇金淋巴瘤;本次獲批的適應症為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。

根據Gilead Sciences,Inc.和Novartis Pharma Schweiz AG已公佈的財務報吿,2020年度,Yescarta、Kymriah及Tecartus全球銷售額分別約為5.63億美元、4.74億美元及0.44億美元。

該產品由復星凱特從KitePharma引進、獲得在中國內地、香港特別行政區和澳門特別行政區的技術及商業化權利。2021年6月,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)獲國家藥監局臨牀試驗批准。

截至本公吿日,除復星凱特本次獲批上市產品外,中國境內(不包括港澳台,下同)尚無其他CAR-T細胞治療產品獲批上市。截至2021年5月,復星凱特現階段針對該產品累計研發投入約為人民幣67,540萬元(含專利及技術許可費用,未經審計)。

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