惠及千万患者:康哲药业口服创新药纳入突破性品种,白癜风治疗添新选择

财中社
Dec 15, 2025

  12月15日,康哲药业(00867)发布公告,旗下德镁医药有限公司的创新口服小分子JAK1抑制剂Povorcitinib已获中国国家药品监督管理局批准纳入突破性治疗品种名单,适应症为成人患者非节段型白癜风。这一认定将加速该产品的研发与审评进程,若在中国获批上市,有望为约820万非节段型白癜风患者提供新的治疗选择。

  Povorcitinib目前正在进行的3期临床试验包括非节段型白癜风、中重度化脓性汗腺炎和结节性痒疹,且有2期试验针对哮喘。公告提到,该产品在全球多中心2b期临床研究中显示出显著疗效,治疗24周后,接受Povorcitinib治疗的患者全身皮损显著复色,且长期使用耐受性良好。

  此外,德镁医药已获得NMPA的临床试验批准,启动产品在中国的临床开发工作。

(文章来源:财中社)

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