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Press release
Nov 30, 2021 21:52 JST
Source:
SinoMab BioScience Limited
中国抗体公布旗舰产品SM03完成在中国III期临床试验招募
香港, Nov 30, 2021 - (ACN Newswire) - 中国抗体制药有限公司(“中国抗体”或“公司”,联交所股份代号:3681.HK),专注研究、发展、制造及商业化免疫性疾病疗法的香港生物制药公司,欣然宣布于二零二一年十一月三十日,旗舰产品SM03 (Suciraslimab)治疗类风湿关节炎(RA)的III期临床试验已达成招募510名受试者的预期目标,并将继续纳入已处于筛选期且符合试验入排标准的受试者至二零二一年十二月底。
SM03(Suciraslimab)是全球首个用于RA治疗的抗CD22单克隆抗体,对其他自身免疫性疾病亦具有潜在疗效,目前正在中国进行III期临床试验。该III期临床试验是一项多中心随机双盲、甲氨蝶呤(MTX)对照平行入组研究,以确证接受Suciraslimab联合甲氨蝶呤(MTX)治疗活动性类风湿关节炎患者的临床疗效及长期安全性。
Suciraslimab的疗效和安全性先前已在针对中重度活动性RA的II期临床研究中进行了评估。近期公布的研究结果表明,与仅使用甲氨蝶呤(MTX)背景治疗加安慰剂的受试者组相比,以600mg剂量接受4次或者6次Suciraslimab治疗,在整个24周的治疗中均表现出良好的疗效与安全耐受性。在稳定剂量的甲氨蝶呤(MTX)治疗背景下,Suciraslimab可有效降低中重度RA患者的疾病活动度,缓解RA疾病症状。
公司执行董事、主席兼首席执行官梁瑞安博士表示: “继公司早前公布旗舰产品SM03表现出良好的疗效与安全耐受性的研究结果后,完成三期临床试验的招募,是研发进程的重大里程碑; 随着SM03临床试验的顺利推进, 标志着SM03即将正式步入商业化阶段。”
关于中国抗体制药有限公司
中国抗体制药有限公司专注于研究、发展、制造及商业化免疫性疾病疗法。公司注重科技研发,其旗舰产品SM03为全球首项用以治疗类风湿关节炎的潜在抗CD22单抗,已在中国进入类风湿关节炎三期临床试验,并被列为国家十三五重大新药创制专项重大项目。此外还有多个同类靶点首创(First-in-target)及同类首创(First-in-class)在研药物,部分已处于临床阶段,适应症覆盖类风湿性关节炎、系统性红斑狼疮、寻常型天疱疮、非霍奇金氏淋巴瘤、哮喘等具有重大未满足临床需求的疾病。
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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