復星醫藥(600196.SH)：CD19靶點自體CAR-T細胞治療產品阿基侖賽注射液獲批臨牀
格隆匯6月11日丨復星醫藥(600196.SH)宣佈，近日，公司投資的復星凱特生物科技有限公司(截至該公吿日，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”)收到國家藥監局關於同意其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，以下簡稱“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)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)開展該產品新增適應症的臨牀試驗。
該產品是根據美國Kite Pharma,Inc.(“Kite”，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®)經技術轉移而本地化生產，主要用於成人復發難治性大B細胞淋巴瘤(包括瀰漫性大B細胞淋巴瘤(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。2021年3月，Yescarta®用於治療惰性非霍奇金淋巴瘤獲美國FDA批准於美國上市。
截至該公吿日，中國境內(不包括港澳台)尚無CD19靶點自體CAR-T細胞治療產品獲批上市；全球範圍內，除Yescarta®外已上市的CD19靶點自體CAR-T細胞治療產品主要包括：(1)Novartis Pharma Schweiz AG的Kymriah®(2017年8月獲批上市)，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)；(2)Kite的Tecartus®(2020年7月獲批上市)，主要用於治療成人復發/難治性套細胞淋巴瘤；(3)Bristol Myers Squibb Company的Breyanzi®(2021年2月獲批上市)，用於治療成人復發或難治性大B細胞淋巴瘤。根據Gilead Sciences,Inc.和Novartis Pharma SchweizAG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。
截至2021年5月，集團現階段針對該新藥累計研發投入約為人民幣6.754億元(未經審計)。
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