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康方生物-B(09926.HK):IL-4R單抗(AK120)治療特應性皮炎和哮喘II期臨牀研究迅速推進
格隆匯 10-12 16:46

格隆匯10月12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)獲得中國國家藥品監督管理局藥品審評中心(CDE)批准,開展治療中度至重度哮喘的II期臨牀研究。同時,AK120用於治療中度至重度特應性皮炎的全球II期臨牀研究亦已於美國首家研究中心完成首例患者入組,該研究正快速推進中。

IL-4和IL-13是2型炎症的關鍵驅動因素。AK120能夠與IL-4R特異性結合,從而競爭性IL-4、IL-13與IL-4R結合,阻斷其介導的下游信號轉導,從而達到治療特應性皮炎、哮喘、嗜酸性食管炎等2型炎症為主要發病機制的特應性疾病的目的。

目前,中國仍缺乏擁有自主智慧財產權的治療中重度哮喘和中重度特應性皮炎的生物製劑批准上市。隨着AK120針對特應性皮炎和哮喘的臨牀研究進入臨牀開發後期階段,公司預期AK120有望在不久的將來為中國2型炎症為主要發病機制的特應性疾病患者帶來治療希望,填補中國臨牀需求的空白。

IL-4R單抗被認為是治療過敏性疾病的重要靶點,也是目前最為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,該藥物於2020年全球銷售額超過40億美元。

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