中國抗體-B(03681.HK):旗艦產品SM03預期將於2021年年底前商業化
格隆匯 10 月 27日丨中國抗體-B(03681.HK)發佈公告,2020年10月26日,公司已於第22屆亞太風濕病學會聯盟大會上就SM03對類風濕關節炎的臨牀免疫原性研究(題為“抗人CD22單克隆抗體SM03治療中國類風濕關節炎患者的抗藥抗體反應”)(“報告摘要”)結果作出口頭陳述。亞太風濕病學會聯盟是一個代表亞太地區不同國家多個風濕病學會成員的聯盟,致力在亞太地區傳揚及促進風濕病學的發展。
根據披露,SM03是一種新型嵌合單克隆抗體,通過靶向B細胞抗原CD22治療類風濕關節炎。為評估SM03於類風濕關節炎患者中的免疫原性,已對抗藥抗體進行檢測及分析。
公司開發的橋接酶聯免疫吸附試驗方法可專門檢測類風濕關節炎患者對SM03的抗藥抗體反應。本次研究顯示SM03具有温和的免疫原性。在活動性類風濕關節炎的中國患者中,結合甲氨蝶呤的SM03治療有效,免疫原性不常見且温和。
公司的旗艦產品SM03為全球首個開展治療類風濕關節炎臨牀試驗的CD22靶向單抗藥物,對其他免疫性疾病亦具有潛在療效,目前在中國進行III期臨牀試驗,預期將於2021年年底前商業化。
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