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科濟藥業-B(02171.HK):國家藥品監督管理局批准賽愷澤®的新藥上市申請
格隆匯 03-01 12:32

格隆匯3月1日丨科濟藥業-B(02171.HK)宣佈,國家藥品監督管理局("NMPA")已經正式批准賽愷澤®(澤沃基奧侖賽注射液,產品編號:CT053,一種針對BCMA的自體CAR-T候選產品)的新藥上市申請("NDA"),用於治療復發或難治性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)。

賽愷澤®是一種自體BCMA靶向CAR-T細胞產品,它是通過慢病毒轉導T細胞產生的。慢病毒編碼的CAR包括全人源BCMA特異性單鏈可變片段("scFv"),人CD8α鉸鏈結構域、CD8α跨膜結構域、4-1 BB協同刺激結構域以及CD3ζ激活結構域。自研的新全人源scFv具有較高的結合親和力和穩定性。

賽愷澤®的獲批是基於一項在中國進行的開放標籤、單臂、多中心II期的臨牀試驗(LUMMICAR STUDY 1,NCT03975907)。根據2022年美國血液學會("ASH")公佈的試驗結果,賽愷澤®表現出令人鼓舞的療效和良好的安全性。

多發性骨髓瘤是一種難治性的惡性漿細胞疾病,約佔所有血液腫瘤的10%。隨着中國老齡化的加速以及人口平均預期壽命的提高,預計多發性骨髓瘤患病人數將持續增加,根據Frost and Sullivan估計,2023年中國多發性骨髓瘤的患病人數大約為15.3萬人,新發病例數為2.32萬人,預計中國多發性骨髓瘤的患病人數於2030年將增長至26.63萬人。

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