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中國抗體-B(03681.HK):SM03完成在中國III期臨牀試驗招募
格隆匯 11-30 19:12

格隆匯11月30日丨中國抗體-B(03681.HK)發佈公吿,於2021年11月30日,SM03 (Suciraslimab)治療類風濕關節炎(RA)的III期臨牀試驗已達成招募510名受試者的預期目標,並將繼續納入已處於篩選期且符合試驗入排標準的受試者至2021年12月底。該III期臨牀試驗是一項多中心隨機雙盲、甲氨蝶呤(MTX)對照平行入組研究,以確證接受Suciraslimab聯合甲氨蝶呤(MTX)治療活動性RA患者的臨牀療效及長期安全性。

Suciraslimab的療效和安全性先前已在針對中重度活動性RA的II期臨牀研究中進行了評估。近期公佈的研究結果表明,與僅使用甲氨蝶呤(MTX)背景治療加安慰劑的受試者組相比,以600mg劑量接受4次或者6次Suciraslimab治療,在整個24周的治療中均表現出良好的療效與安全耐受性。在穩定劑量的甲氨蝶呤(MTX)治療背景下,Suciraslimab可有效降低中重度RA患者的疾病活動度,緩解RA疾病症狀。

公司的旗艦產品SM03(Suciraslimab)是全球首個用於RA治療的抗CD22單克隆抗體,對其他自身免疫性疾病亦具有潛在療效,目前正在中國進行III期臨牀試驗。

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