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)
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.