智通财经APP讯，荃信生物-B(02509)发布公告，本公司自主研发的鲁塞奇塔单抗注射液(抗IL 17A单克隆抗体，研发代号：QX002N)的新药上市申请(NDA)，已于2026年3月9日获国家药品监督管理局受理。
此次申报基于一项多中心、随机、双盲、安慰剂对照的III期临床试验(登记号： CTR20232574)，该临床研究成果于2025年10月以口头报告形式亮相美国风湿病学会年会(ACR Convergence)，研究结果显示，鲁塞奇塔单抗对非甾体抗炎药反应不足或存在禁忌的活动性AS受试者，展现出显著且持续的疾病活动度、体征与症状改善，且在52周治疗及随访中展现出的安全性、耐受性良好。在肿瘤坏死因子(TNF)抑制剂经治人群中，该药物的疗效同样显著。此外，鲁塞奇塔单抗可有效缓解受试者脊柱和骶髂关节的水肿及炎症情况，为该药物抑制疾病活动提供了明确的客观影像学依据。
鲁塞奇塔单抗是本公司首款获得NDA受理的创新药，也是继赛乐信®之后第二款达到NDA阶段的生物药，标志着本公司研发管线逐步进入收获期。
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