中國抗體-B(03681.HK)：SM17新藥研究申請獲國家藥監局批准
格隆匯9月11日丨中國抗體-B(03681.HK)公吿，於2023年9月8日，公司所提交治療特應性皮炎("特應性皮炎")的同類首創(First-in-Class)治療產品SM17的新藥研究申請，已獲中國國家藥品監督管理局批准。新藥研究申請獲批准將使公司能夠在中國開展治療特應性皮炎適應症的臨牀研發項目。公司計劃於本年度第四季度在中國啟動一項I期臨牀試驗，旨在探索SM17在中國人羣中的安全性並啟動SM17治療過敏性疾病的臨牀開發計劃。
SM17是一種全新、同類首創(First-in-Class)的人源化IgG4-k單克隆抗體，其能透過靶向"警戒素(Alarmin)"通路的關鍵分子人白細胞介素25(IL-25)受體調控II型過敏反應通路。SM17通過抑制IL-25結合到2型先天淋巴細胞(ILC2s)及2型輔助T細胞(Th2)上的受體(IL-17RB)後誘發的一連串反應，從而對下游信號通路的Th2型白介素IL-4、IL-5、IL-13均有抑制效果。
IL-25為一類關鍵的"警戒素"，已被證明與自身免疫性及炎症性皮膚病的病理變化有關，例如特應性皮炎。特應性皮炎患者於下列疾病的全因死亡率以及特定原因死亡率亦有所增加，這些疾病包括感染、呼吸、胃腸道，以及腫瘤性疾病。目前已獲批上市的特應性皮炎療法(包括生物製劑)可以大大改善患者的濕疹面積和嚴重程度指數以及生活質量。然而，對已獲批療法反應不大的患者仍存在未滿足的醫療需求。
正在美國進行的SM17I期研究已接近完成，預計於本月下旬(2023年9月)完成最後一例受試者最後一次(LPLV)訪視。截至公吿日期，未有報吿與藥物相關的嚴重不良事件，顯示此產品在人體中具有良好的耐受性，並表現出非常好的安全性。公司相信靶向Th2炎性細胞因子通路的上游療法(例如IL-25的受體)將對皮膚炎症產生廣泛的作用，意味着SM17在特應性皮炎治療上具有更安全和更有效差異化優勢的巨大潛力。
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