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康方生物-B(09926.HK):AK120獲批開展治療中重度特應性皮炎全球II期臨牀研究
格隆匯 09-27 06:24

格隆匯9月27日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的創新候選藥物IL-4R單克隆抗體(研發代號:AK120)獲得美國食品藥品監督管理局同意,啟動治療中度至重度特應性皮炎的全球性II期臨牀研究。這是一項多中心、隨機、雙盲、安慰劑對照、平行分組、劑量探索的II期臨牀研究,以評估AK120在中度至重度特應性皮炎的成人受試者中的療效和安全性。

此前,AK120已經在紐西蘭和澳大利亞完成了健康受試者的單劑量遞增Ia期臨牀研究和用於治療特應性皮炎多劑量遞增的Ib期臨牀研究。根據首次人體(FIH)研究中獲得的初步數據,AK120在成人健康受試者中以單劑量高達600毫克進行皮下給藥時,安全且耐受性良好。在患有中度至重度特應性皮炎的成年受試者中,按每週皮下給藥劑量高達300毫克的情況下,AK120同樣表現出良好的安全性和耐受性。

IL-4R目前為最暢銷的自身免疫領域抗體蛋白藥物之一。據公開數據顯示,隨着IL-4R靶向藥物滲透率的提高,預計2024年IL-4R抗體藥物的全球市場銷售額將達約122億美元,中國市場將達約6.07億美元。目前全球IL-4R單抗僅有度普利尤單抗獲批上市,該藥物2020年全球銷售額超過40億美元。

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