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翰森製藥(03692.HK)伊奈利珠單抗注射液第三項上市許可申請獲受理
阿思達克 05-30 17:48
翰森製藥(03692.HK)公布,昕越(伊奈利珠單抗注射液)的第三項上市許可申請(BLA)獲國家藥品監督管理局受理,用於治療全身型重症肌無力(gMG)成人患者。 伊奈利珠單抗是靶向CD19 B細胞消耗性抗體,並於2022年3月14日獲准在中國上市,適用於抗水通道蛋白4(AQP4)抗體陽性的視神經脊髓炎譜系障礙(NMOSD)成人患者的治療,其後該藥於今年3月4日,第二項BLA獲藥監局受理,用於治療免疫球蛋白G4相關性疾病(IgG4-RD)。
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