智通财经APP讯，先声药业(02096)发布公告，于2026年4月29日，集团重新提交的与香港康乃德生物医药有限公司合作的创新药乐德奇拜单抗新药上市申请(NDA)获国家药品监督管理局(NMPA)受理，用于治疗成人及青少年特应性皮炎。
乐德奇拜单抗是靶向IL-4Rα(IL-4Rα是IL-4受体和IL-13受体的共同亚基)的全人源单抗。乐德奇拜单抗与IL-4Rα结合可以有效阻断IL-4和IL-13功能，进而阻断 Th2型炎症通路，从而达到有效治疗特应性皮炎及哮喘等Th2相关炎症性疾病的目的。
三期临床研究显示，乐德奇拜单抗不仅起效迅速，且在持续治疗后的累积获益更为显著，呈现与同类产品相比更有效的潜力。第16周，乐德奇拜单抗组EASI-75、 EASI-90和IGA 0/1，应答率分别达到74.2%、43.0%和47.7%(p < 0.0001)，表明患者在治疗早期即可获得明确的临床获益;至第52周，EASI-75、EASI-90和IGA0/1 应答率分别升至96.6%、85.3%和87.1%，显示出持续治疗背景下更为突出的深度缓解优势。
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