北海康成-B(01228.HK)公佈CAN106的I期試驗積極數據
格隆匯2月7日丨北海康成-B(01228.HK)發佈公吿,2022年2月7日,公司公佈了在新加坡進行的項目CAN106(一種長效重組人源化單克隆抗體,用於治療補體C5介導的疾病)I期單劑量遞增(SAD)研究的頂線結果。此項研究共納入了31名健康志願者,隨機入組六個劑量組(0.25,0.75,2,4,8和12mg/kg CAN106),隨訪時間至少 112天。最終結果證實,CAN106是安全的,並且耐受性良好,沒有藥物相關的嚴重不良事件(SAEs)。
同時,北海康成在中國的臨牀試驗申請已獲得批准,可在中國開展治療陣發性睡眠性血紅蛋白尿症(PNH)的Ib/II期試驗。PNH是一種致命的罕見疾病,這種疾病因補體系統失調,破壞紅細胞而導致溶血。在許多國家地區,抗C5的治療手段比較有限,而在中國,目前尚無獲批的PNH長效抗體療法。北海康成與藥明生物在罕見病戰略伙伴關係框架下合作開發了CAN106。北海康成擁有CAN106的全球獨家開發和商業化的權利,並計劃在全球範圍內為PNH以及其他涉及C5蛋白激活的補體介導疾病開發CAN106。
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