復星醫藥(600196.SH):復星凱特CAR-T療法正式獲批
格隆匯6月23日丨復星醫藥(600196.SH)宣佈,2021年6月22日,國家藥監局網站公開信息顯示,公司投資的復星凱特生物科技有限公司(截至該公吿日,公司控股子公司復星醫藥產業持有其50%股權;簡稱“復星凱特”)的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,簡稱“該產品”或“該CAR-T細胞治療產品”)的上市註冊審批狀態更新為“藥品批准證明文件待領取”,批准文號為“國藥準字S20210019”。
該產品是根據Gilead Sciences, Inc.控股子公司美國Kite Pharma的抗人CD19 CAR-T細胞注射液(商品名Yescarta®)經技術轉移並擬於中國境內(不包括港澳台)進行本地化生產。該產品該次申請註冊的適應症為用於成人復發或難治性大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。
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。
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