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信達生物(01801.HK):國家藥監局批准BCMA CAR-T產品福可蘇®(伊基奧侖賽注射液)用於治療復發難治多發性骨髓瘤成人患者
格隆匯 07-03 07:53

格隆匯7月3日丨信達生物(01801.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已經正式批准公司與馴鹿生物共同開發及商業化的細胞免疫治療產品福可®(伊基奧侖賽注射液,公司研發代號:IBI326;馴鹿生物研發代號:CT103A)的新藥上市申請(“NDA”),用於治療復發難治多發性骨髓瘤成人患者,既往經過至少3線治療後進展(至少使用過一種蛋白酶體抑制劑及免疫調節劑)。

福可蘇®(伊基奧侖賽注射液)是一種針對B細胞成熟抗原(“BCMA”)的CAR-T細胞療法,以慢病毒為基因載體轉染自體T細胞,CAR包含全人源scFv、CD8a鉸鏈和跨膜、4-1BB共刺激和CD3ζ啟動結構域。基於嚴格的分子結構篩選,通過全面的體內外功能評價,福可蘇®具有快速和強勁的療效,並有突出的體內持久存續性,可使患者獲得更高、更深的緩解,持續守護多發性骨髓瘤患者。

此次NDA獲批是基於FUMANBA-1臨牀研究資料(CTR20192510,NCT05066646)。 FUMANBA-1臨牀研究是一項評估伊基奧侖賽注射液治療復發╱難治性多發性骨髓瘤患者的中國多中心I/II期註冊臨牀試驗。最新長期隨訪資料更新在2023年美國臨牀腫瘤學術年會(ASCO)以壁報形式展示(摘要編號:8025)。

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