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中國抗體-B(03681.HK):SN1011在中國I期臨牀完成最後一例受試者最後一次訪視
格隆匯 07-23 21:26

格隆匯7月23日丨中國抗體-B(03681.HK)發佈公吿,SN1011已於2021年7月23日在中國完成I期劑量爬坡研究的最後一例受試者最後一次訪視。該研究中,共入組71例健康受試者,SN1011劑量爬至800mg。受試者均未報吿嚴重不良事件。該產品顯示良好的安全性和耐受性。預期臨牀研究報吿將於今年第三季度末發佈。本次I期臨牀試驗旨在評估SN1011治療自身免疫性疾病的安全性、耐受性、藥代動力學、藥理動力學及II期臨牀推薦劑量。

繼SN1011治療尋常型天皰瘡及系統性紅斑狼瘡適應症的新藥研究申請獲批後,公司於中國現正啟動針對尋常型天皰瘡的II期臨牀研究。公司亦計劃於短期內啟動針對系統性紅斑狼瘡的II期臨牀研究。

SN1011是公司的第三代可逆共價BTK抑制劑,其設計在長期治療系統性紅斑狼瘡、尋常型天皰瘡、多發性硬化症、類風濕關節炎及其他免疫性疾病方面,具備更高選擇性、更卓越療效及更高安全性。在作用機理、親和性、靶向選擇性及安全性方面,SN1011與目前市場現有的BTK抑制劑(如依魯替尼)等具有差異性優勢。

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