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國內首款CAR-T產品即將獲批,細胞療法賽道將迎收穫期
uSMART盈立智投 06-21 11:13

來源 | 生物探索

近日,國家藥監局官網顯示,復星凱特靶向 CD19 CAR-T 阿基倫塞注射液在國內的上市申請已處於在“在審批”階段,有望於近期獲 NMPA 批準上市。此款藥物將成爲國內首個上市的 CAR-T 細胞療法。

阿基侖賽注射液是復星凱特從吉利德子公司Kite製藥引進的靶向CD19自體CAR-T細胞治療產品Yescarta,擁有其在中國包括香港、澳門的商業化權利,並於中國境內(不包括港澳臺)進行本地化生產。

2017年10月,Yescarta獲美國FDA批準上市,成爲全球首款用於治療復發/難治性大B細胞淋巴瘤的CAR-T細胞藥物。在完成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後,2020年2月復星凱特在國內提交了阿基侖賽注射液上市申請,用於治療治療成人復發難治性大B細胞淋巴瘤,並於2020年3月被CDE納入優先審評。

如今,全球CAR-T市場規模已從2017年的0.1億美元增長到2019年的7億美元,預計2024年將至66億美元,2030年達至218億美元。目前全球已有五款CAR-T藥物上市,包括諾華的Kymriah、吉利德的Yescarta及Tecartus、BMS的Liso-cel、藍鳥生物Abecma,其中三款產品於2020年下半年後上市。

目前在國內,已有335個正在進行的CAR-T臨牀試驗,其中,多款產品即將步入商業化階段,如藥明巨諾的JWCAR029已於4月底完成生產現場檢查,也有望年內在中國獲批上市;傳奇生物的cilta-cel有望在年底前獲FDA批準在美國上市,並於下半年向中國國家藥監局遞交上市申請;科濟藥業計劃在2022年上半年向中國國家藥監局提交其CT053的上市申請。

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