康寧傑瑞製藥-B(09966.HK)KN019用於治療類風濕性關節炎II期臨牀試驗在中國完成首例患者給藥
格隆匯12月12日丨康寧傑瑞製藥-B(09966.HK)公告,基於CTLA-4的免疫抑制融合蛋白候選藥物KN019的II期臨牀試驗(KN019-201)完成首例患者給藥。
KN019-201試驗是一項在中國開展的II期臨牀試驗,以評估KN019在過往MTX治療無法充分治療的活動性類風濕性關節炎患者中的有效性及安全性。
據悉,公司自主開發的KN019為一種基於CTLA-4的免疫抑制融合蛋白候選藥物。CTLA-4是一種在T細胞表達的蛋白質,能與CD28競爭結合B7.1和B7.2。由於CD28與B7.1和B7.2的結合是啟動T細胞激活的關鍵要素之一,因此KN19能夠抑制T細胞的激活。全球唯一獲批准的兩種CTLA-4-Fc融合蛋白為Nulojix(貝拉西普)及Orencia(阿巴西普)。
KN019是中國唯一與貝拉西普氨基酸序列相同的CTLA-4-Fc融合蛋白候選藥物。目前,公司對KN019進行了全面的臨牀前期研究,而KN019在中國完成的I期臨牀試驗中在健康受試者顯示出良好的安全性和PK(藥代動力學)特徵,並顯示出良好的藥理作用。本公司計劃開發KN019針對各種適應症,包括自身免疫性疾病、腎移植排斥反應及腫瘤輔助治療。
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