6月27日,丽珠医药和鑫康合生物在药物临床试验登记与信息公示平台登记了一项III期临床试验,旨在评估LZM012对比司库奇尤单抗(商品名:可善挺)治疗中度至重度慢性斑块状银屑病的有效性和安全性。

该研究拟纳入918例伴或不伴有银屑病关节炎的中度至重度斑块状银屑病成人受试者,受试者需同时满足①银屑病面积与严重程度指数(PASI)评分≥12分②静态医生整体评估(sPGA)评分≥3分③受累的体表面积(BSA)≥10%的标准。研究的主要终点为第12周时达到PASI 100 的受试者比例(PASI100应答率)。试验组患者接受每4周1次320mg LZM012治疗,对照组患者接受每4周1次300mg司库奇尤单抗或者安慰剂治疗。


LZM012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。

目前,全球共4款IL-17靶向药物获批上市,分别为司库奇尤单抗(诺华)、比吉利珠单抗(UCB)、依奇珠单抗(礼来)和netakimab(Biocad/上药博康)。此外,夫那奇珠单抗(恒瑞)和赛立奇单抗(智翔金泰)也已申报上市。

据诺华2022年财报,司库奇尤单抗全球销售额为47.88亿美元,是当前销量最好的IL-17靶向药物。

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