荃信生物强直性脊柱炎新药III期试验达主要终点
2月24日，荃信生物-B（02509）发布公告，公司自主研发的QX002N注射液用于治疗强直性脊柱炎的III期临床试验达到了主要终点。根据公告数据，接受160mg QX002N每四周给药一次的治疗组在第16周的ASAS40应答率为40.4%，显著高于安慰剂组的18.9%（P<0.0001）。此外，关键次要终点的ASAS20应答率也显示出显著差异，QX002N组为65.2%，安慰剂组为41.3%（P<0.0001）。
此次试验由北京协和医院的曾小峰教授牵头，共纳入641例中重度活动性强直性脊柱炎受试者，其中QX002N组322例，安慰剂组319例。在安全性方面，QX002N在16周双盲治疗期内，大多数患者的不良事件为I-II级，且未发现新的安全性信号。QX002N注射液的成功是公司研发的重要阶段性成果，后续研发工作将积极推进，并会根据进展情况进行信息披露。
（文章来源：财中社）
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