智通财经APP讯，康方生物(09926)发布公告，中国国家药品监督管理局(NMPA)已于近日批准爱达罗®(依若奇单抗，IL-12/IL-23)的新药上市申请(NDA)，用于治疗中度至重度斑块型银屑病成人患者。
依若奇单抗是公司自身免疫性疾病领域首个获批上市的一类新药，也是继伊努西单抗之后公司第二个获批上市的非肿瘤新药。此次NDA获批是基于依若奇单抗针对中国中重度斑块状银屑病受试者开展的5项临床研究，其中的两项关键III期临床研究，提供了依若奇单抗在中重度斑块状银屑病患者中16周和52周有效性和安全性数据。
作为首款且唯一国产IL-12/IL-23单抗创新药，依若奇单抗具有突出的临床疗效和优异的安全性，且给药频次少，有望为我国中度至重度银屑病患者提供一种更高效、安全、便捷且经济的治疗方案。
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