智通财经APP讯，丽珠医药(01513)发布公告，近日，公司的控股子公司珠海市丽珠单抗生物技术有限公司(丽珠单抗)收到国家药品监督管理局核准签发的《药品注册证书》(证书编号：2026S03179)。莱康奇塔单抗注射液(皮下注射)由丽珠单抗与北京鑫康合生物医药科技有限公司联合开发，为重组抗人 IL-17A/F 人源化单克隆抗体注射液，系中国首个自主研发的IL-17A/F 双靶点创新生物制剂，可通过同步阻断 IL-17A 与 IL-17F 促炎因数发挥作用，本次注册申请的适应症为：用于适合接受系统治疗或光疗的中重度斑块状银屑病成人患者。
本品已完成中重度斑块状银屑病的Ⅲ期临床试验，该研究以司库奇尤单抗为阳性对照，数据表明，本品在起效速度、皮损清除率及长期疗效方面均优于对照组，安全性与对照组相当。本品无需初始密集诱导期，给药频次较对照组减少，可提升患者的使用体验，提高依从性。
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