麗珠醫藥(01513.HK)擬用於中重度斑塊型銀屑病等適應症新藥臨牀試驗申請獲受理
格隆匯11月21日丨麗珠醫藥(01513.HK)發佈公告,近日,公司控股附屬公司珠海市麗珠單抗生物技術有限公司(以下簡稱“麗珠單抗”)與北京鑫康合生物醫藥科技有限公司聯合申報的“重組抗人IL-17A/F人源化單克隆抗體注射液”臨牀試驗申請獲國家藥品監督管理局受理。
“重組抗人IL-17A/F人源化單克隆抗體注射液”歷經4年研發,臨牀試驗申請已於2019年11月11日獲得受理(受理號:CXSL1900130國)。
重組抗人IL-17A/F人源化單克隆抗體注射液能同時靶向同源二聚體IL-17A-A和IL-17F-F,以及異源二聚體IL-17A-F。IL-17A和IL-17F在體內以同源二聚體IL-17A-A和IL-17F-F,以及異源二聚體IL-17A-F形式存在。它們主要由T輔助細胞Th17亞羣產生,也可由其他T細胞、中性粒細胞和肥大細胞產生。這些二聚體作用於受體IL-17RA及IL-17RC,能促進其他促炎細胞因子(如IL-6、TNFα、IL-1β、IL-20家族細胞因子、GM-CSF)以及效應蛋白的表達,並進一步導致中性粒細胞和巨噬細胞以及上皮細胞和成纖維細胞的活化,在許多自身免疫性疾病(如銀屑病等)病理生理學中發揮重要作用。該品通過阻斷IL-17A/F及其下游通路相應受體的相互作用,擬用於中重度斑塊型銀屑病、強直性脊柱炎等自身免疫相關的適應症。
“重組抗IL-17A/F人源化單克隆抗體”是麗珠單抗向北京鑫康合生物醫藥科技有限公司唯一股東蘇州鑫康合生物醫藥科技有限公司引進,由蘇州鑫康合生物醫藥科技有限公司完成分子發現早期研究,麗珠單抗已獲得該項目在全球範圍內的開發、註冊、生產、銷售和分許可的獨佔性權益。截至公告披露日,“重組抗人IL-17A/F人源化單克隆抗體注射液”已累計研發投入約為人民幣3,773.47萬元。
該該品臨牀試驗申請已獲受理,自受理繳費之日起60日內,未收到國家藥品監督管理局藥品審評中心否定或質疑的,即可按照提交的方案開展臨牀試驗。待臨牀試驗完成並報藥監局審批通過後方可生產上市。
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