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荃信生物-B(02509.HK):QX002N治療強直性脊柱炎的III期臨牀試驗達到主要終點
格隆匯 02-24 18:34

格隆匯2月24日丨荃信生物-B(02509.HK)發佈公告,公司自主研發的QX002N注射液用於治療強直性脊柱炎(ankylosing spondylitis,AS)的III期臨牀試驗達到主要終點。數據顯示,QX002N在中重度活動性強直性脊柱炎患者中展出優異的療效以及良好的安全性和耐受性。

本次試驗是由北京協和醫院曾小峯教授牽頭開展的一項在活動性強直性脊柱炎患者中評價QX002N注射液的療效和安全性的多中心、隨機、雙盲、安慰劑對照的III期臨牀研究,目前已完成首次分析。研究共納入641例中重度活動性強直性脊柱炎受試者,其中QX002N組322例,安慰劑組319例。

QX002N注射液是一款靶向IL-17A的高親和力單克隆抗體藥物。IL-17A是IL-17細胞因子超家族的成員,在多種自身免疫性疾病的發病機制中起着關鍵作用。IL-17A通過誘導白細胞介素-6(IL-6)、趨化因子CXCL1等促炎細胞因子釋放並與之協同作用,加重慢性炎症。同時,其參與骨重塑的調節機制,被確定爲強直性脊柱炎發病的主要因素。QX002N注射液通過特異性靶向IL-17A(包括IL17AA和IL-17AF),阻斷其與受體複合物結合(包括IL-17RA及IL-17RC),阻止若幹促炎信號通路的後續激活,從而抑制炎症的發生和發展。

QX002N注射液用於治療AS的III期臨牀試驗達到主要終點是該項目的重要階段性成果,公司將積極推進後續研發工作,並根據研發進展情況及時進行信息披露。

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