中访网数据 上海君实生物医药科技股份有限公司今日宣布，其自主研发的创新药偌考奇拜单抗注射液(JS005)用于治疗中重度斑块状银屑病的新药上市申请，已获得国家药品监督管理局受理。该药物是一款重组人源化抗IL-17A单克隆抗体，通过阻断炎症信号通路发挥作用。此次申请基于一项纳入747例患者的全国多中心关键III期临床研究。研究结果显示，治疗12周后，药物在改善银屑病面积与严重程度指数及医师评估评分方面显著优于安慰剂，疗效可持续至52周，且安全性良好。银屑病是一种常见的慢性免疫性疾病，在中国患病率呈上升趋势，对患者身心健康影响显著。若获批上市，偌考奇拜单抗将为该患者群体提供新的治疗选择。公司同时提示，新药审评审批周期长、环节多，最终能否获批存在不确定性。
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