科濟藥業-B(02171.HK):國家藥監局受理澤沃基奧侖賽注射液新藥上市申請
格隆匯10月18日丨科濟藥業-B(02171.HK)發佈公吿,中國國家藥品監督管理局(NMPA)已受理澤沃基奧侖賽注射液(zevorcabtagene autoleucel,研發代號:CT053)的新藥上市申請(NDA),一種用於治療復發╱難治多發性骨髓瘤的全人抗自體BCMA CAR-T細胞候選產品。
此NDA被受理是基於在中國進行的開放標籤、單臂I/II期臨牀試驗(LUMMICAR STUDY 1(方案編號:CT053-MM-01))的數據。研究結果顯示,澤沃基奧侖賽注射液具有良好的安全性和療效。澤沃基奧侖賽注射液對伴隨高危因素患者也表現為一種前景光明的治療手段。
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