三生國健(688336.SH)：抗IL-4Rα人源化單克隆抗體Ib期臨牀試驗完成首例患者入組
格隆匯10月20日丨三生國健(688336.SH)公佈，近日，公司自主創新研發的抗白介素4受體alpha(IL-4Rα)的人源化單克隆抗體藥物(研發代號：611)，目前正在開展Ib期臨牀研究，成功完成了首例受試者入組。
據悉，特應性皮炎(Atopic Dermatitis，AD)是一種慢性、複發性、炎症性皮膚病。中重度特應性皮炎患者通常全身大部皮膚紅疹，引發強烈持續的瘙癢、皮膚乾燥、結痴、滲液等症狀，治療藥物非常有限，嚴重地影響了患者生活質量。過去30年，全球範圍內AD患病率逐漸增加，我國1～7歲兒童達到12.94%，1～12月嬰兒更是高達30.48%。特應性皮炎屬於自身免疫性疾病，由異常免疫反應引起，致病原因涉及免疫的多個環節，如朗格漢斯細胞和皮膚樹突細胞對變應原的提呈、Th2為主的異常免疫反應、調節性T細胞功能障礙、IgE過度產生和嗜酸性粒細胞升高等等。目前，皮質類固醇類藥物是治療此類疾病最常用的藥物，但該類藥物較強的副作用限制了它的應用，因此此類疾病仍具有廣泛的未被滿足的臨牀需求。
IL-4Rα是白介素4(IL-4)及白介素13(IL-13)的信號傳導複合體的一部分，在特應性皮炎的發病機制中起關鍵性作用。611能夠通過抑制IL-4R，阻斷IL-4和IL-13的信號傳導，實現對免疫功能的調節，包括抑制Th2細胞的分化，緩解呼吸道過敏反應以及IgE的合成等，從而達到緩解特應性皮炎等疾病的作用。
在全球範圍內針對白細胞介素4受體(IL-4Rα)靶點的上市藥物僅有再生元/賽諾菲研發的Dupilumab(商品名Dupixent)，2020年全球銷售規模40.4億美元，已獲批的適應症包括中到重度特應性皮炎，哮喘以及鼻息肉導致的鼻竇炎。基於已完成的研究結果表明，611藥物的作用機制及臨牀前和臨牀試驗數據與Dupilumab有較高的相似性，該產品具有國際市場的競爭的潛力。
611目前正在開展Ib期臨牀研究，旨在評價“重組抗IL-4Rα人源化單克隆抗體注射液(611)在中度至重度成人特應性皮炎患者中的單次/多次給藥的安全性、耐受性與藥代動力學和藥效學研究”，已於近日成功完成了首例受試者入組。該產品此前在美國已完成在健康成年志願者單次給藥、劑量遞增的Ia期臨牀試驗；研究結果顯示出良好的耐受性和安全性，藥代動力學特徵提示良好的成藥性。
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