中國抗體-B(03681.HK)治療類風濕關節炎藥物獲藥監局受理生物製品許可申請
中國抗體-B(03681.HK)公布,中國國家藥品監督管理局已受理公司旗艦產品SM 03(Suciraslimab)用於治療類風濕關節炎(RA)的生物製品許可申請。該項申請為公司自成立以來首項提交的上市申請。該藥物為公司自主開發的產品,是全球首個用於類風濕關節炎(RA)及其他自身免疫性疾病治療的抗CD22單克隆抗體。
集團指,已揭盲的III期數據顯示,經過24週雙盲治療,藥物達到主要終點,並對活動性類風濕關節炎患者取得顯著臨床療效。
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