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Press release
Nov 30, 2021 21:51 JST
Source:
SinoMab BioScience Limited
中國抗體公佈旗艦產品SM03完成在中國III期臨床試驗招募
香港, Nov 30, 2021 - (ACN Newswire) - 中國抗體製藥有限公司(「中國抗體」或「公司」,聯交所股份代號:3681.HK),專注研究、發展、製造及商業化免疫性疾病療法的香港生物製藥公司,欣然宣佈於二零二一年十一月三十日,旗艦產品SM03 (Suciraslimab)治療類風濕關節炎(RA)的III期臨床試驗已達成招募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二零二一年十二月底。
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期臨床試驗。該III期臨床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)治療活動性類風濕關節炎患者的臨床療效及長期安全性。
Suciraslimab的療效和安全性先前已在針對中重度活動性RA的II期臨床研究中進行了評估。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。
公司執行董事、主席兼首席執行官梁瑞安博士表示:「繼公司早前公佈旗艦產品SM03表現出良好的療效與安全耐受性的研究結果後,完成三期臨床試驗的招募,是研發進程的重大里程碑; 隨著SM03臨床試驗的順利推進, 標誌著SM03即將正式步入商業化階段。」
關於中國抗體製藥有限公司
中國抗體製藥有限公司專注於研究、發展、製造及商業化免疫性疾病療法。公司注重科技研發,其旗艦產品SM03為全球首項用以治療類風濕關節炎的潛在抗CD22單抗,已在中國進入類風濕關節炎三期臨床試驗,並被列為國家十三五重大新藥創制專項重大項目。此外還有多個同類靶點首創(First-in-target)及同類首創(First-in-class)在研藥物,部分已處於臨床階段,適應症覆蓋類風濕性關節炎、系統性紅斑狼瘡、尋常型天皰瘡、非霍奇金氏淋巴瘤、哮喘等具有重大未滿足臨床需求的疾病。
Source: SinoMab BioScience Limited
Sectors: BioTech, Healthcare & Pharm
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
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