復星醫藥：益基利侖賽注射液(擬定)用於成人復發難治性大B細胞淋巴瘤治療獲藥品註冊申請受理
格隆匯2月24日丨復星醫藥(600196.SH)公佈，近日，公司投資的合營公司復星凱特生物科技有限公司(截至公告日，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；“復星凱特”)收到《受理通知書》(受理號：CXSS2000006國)，其益基利侖賽注射液(擬定)(即抗人CD19 CAR-T細胞注射液)用於成人復發難治性大B細胞淋巴瘤治療(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)獲國家藥品監督管理局(“國家藥監局”)藥品上市註冊審評受理。
該產品即美國Kite Pharma, Inc.(“Kite Pharma”，系Gilead Sciences, Inc.的控股子公司)的抗人CD19 CAR-T細胞注射液(商品名YESCARTA®)，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Kite Pharma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。
截至公告日，中國境內尚無與該產品具有相同靶點的同類藥物獲批上市。全球已獲批上市的另一款CAR-T細胞免疫治療產品是Novartis Pharma Schweiz AG的KYMRIAH®，其與復星凱特FKC876的靶點同為CD19，主要用於治療兒童和年輕成人(2至25歲)的急性淋巴細胞白血病及成年人復發/難治性大B細胞淋巴瘤(包括瀰漫性大B細胞淋巴瘤、轉化型濾泡性淋巴瘤和原發縱隔B細胞淋巴瘤)。根據Gilead Sciences, Inc.、Novartis Pharma Schweiz AG已公佈的財務報告，2019年度，YESCARTA®、KYMRIAH®全球銷售額分別約4.56億美元、2.78億美元。
截至2020年1月，復星凱特現階段針對該產品累計研發投入約人民幣4.74億元(含專利和技術許可費用，未經審計)。
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