国产创新药持续发力，AD治疗领域将迎来新突破

制药网03-09

特应性皮炎(AD)是常见的慢性炎症性皮肤病，全球患者基数庞大，约有20%的儿童和7-14%的成人患有AD。AD虽不致命，但反复发作的剧烈瘙痒与皮损，对患者睡眠、心理与生活质量造成长期沉重负担，药物市场需求巨大。有数据显示，2024年全球AD药物市场规模约135–140亿美元，2025年已突破159亿美元。面对这一广阔的药物市场需求，国内药企正在积极加快研发的脚步。在AD药物研发中，IL-4R(...

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IL-13的信号传导。未来随着这些产品的获批上市，AD药物领域将迎来新的用药选择。近日，三生国健的SSGJ611、康方生物的曼多奇单抗的新药上市申请也已获得NMPA受理，IL-4α领域的竞争将更加激烈。三生国健表示，SSGJ-611是公司自主研发设计、筛选并人源化的抗IL-4Rα单克隆抗体，具有全新的氨基酸序列。SSGJ-611能够通过特异性的结合IL-4Rα，阻断IL-4和IL-13的信号传导达到缓解特应性皮炎等疾病的作用。除了IL-4R外，另一大阵营JAK抑制剂中，恒瑞医药的艾玛昔替尼在2025年4月顺利上市。艾玛昔替尼是一种高选择性的JAK1抑制剂，对JAK1的选择性是对JAK2的16倍。该药物能通过高选择性抑制JAK1，调节IL-4、IL-5、IL-13、IFN-γ和其他参与AD发病机制的细胞因子的信号传导。因其对JAK2的抑制性低，也能尽量降低发生中性粒细胞减少症与贫血的风险。凌科药业的二代JAK1抑制剂泽普昔替尼近日宣布治疗中重度AD的3期顶线数据，研究数据显示，在主要终点及关键次要终点上，泽普昔替尼两个剂量组均较安慰剂组取得具有高度显著统计学意义(p < 0.0001)的疗效，并同时整体展现出良好的安全性和耐受性。其不良事件发生率与安慰剂相当，与已获批的JAK抑制剂相比安全性具有竞争力。值得一提的是，在AD领域中国药企并不只是替代跟跑。如诺诚健华的ICP-332是TYK2抑制剂，在AD这一适应症上是全球进展快的TYK2新药，目前治疗中重度AD的3期临床试验已完成全部入组。ICP-332 是诺诚健华具有全球自主知识产权的 1 类创新药，是高效、高选择性的新型口服 TYK2 抑制剂，通过特异性结合 TYK2 JH1 结构域，阻断 IL-23、IL-12 和 I 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