智通财经APP获悉，12月24日，CDE网站显示，丽珠医药(01513)/鑫康合生物合作开发的莱康奇塔单抗(LZM012/XKH004)申报上市，用于治疗斑块状银屑病。

莱康奇塔单抗是丽珠医药自鑫康合生物引进的一款IL-17A/IL-17F单抗，可同时靶向同源二聚体IL-17A-A和IL-17F-F，以及异源二聚体IL-17A-F。丽珠医药旗下控股子公司丽珠单抗已获得该产品在全球范围内的开发、注册、生产、销售和分许可的独占性权益。

今年7月，丽珠医药宣布莱康奇塔单抗(320mg，每4周1次)对比司库奇尤单抗(300mg，每4周1次)治疗伴或不伴银屑病关节炎的中度至重度斑块状银屑患者的III期临床试验达到主要终点。

研究结果显示，治疗第12周，莱康奇塔单抗组和司库奇尤单抗达到PASI 100的患者比例分别为49.5%和40.2%，达到非劣效标准并且达到优效标准。

安全性方面，莱康奇塔单抗整体安全性良好，常见不良事件发生率与对照组各类不良事件发生率相当。

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