澤璟製藥(688266.SH):已於近日啟動鹽酸傑克替尼片治療中、重度特應性皮炎III期臨牀試驗
格隆匯6月1日丨澤璟製藥(688266.SH)公佈,公司根據鹽酸傑克替尼片治療中、重度特應性皮炎的II期臨牀試驗期中分析結果,向國家藥品監督管理局藥品審評中心(簡稱“CDE”)遞交了“鹽酸傑克替尼片治療中、重度特應性皮炎成年患者的多中心、隨機、雙盲、安慰劑平行對照III期臨牀研究”方案(方案號ZGJAK025)並獲得同意。公司已於近日啟動鹽酸傑克替尼片治療中、重度特應性皮炎III期臨牀試驗。
鹽酸傑克替尼是公司自主研發的一種新型JAK抑制劑類藥物,屬於1類新藥,公司擁有該產品的自主知識產權。傑克替尼對多種Janus激酶JAK1、JAK2、JAK3和TYK2具有顯著的抑制作用。
根據公開信息,近期有國外進口的JAK抑制劑類藥物在特應性皮炎治療中獲得臨牀試驗成功並獲准上市。到目前為止,尚無國產JAK抑制劑類新藥獲批上市。
特應性皮炎是一種慢性、複發性、炎症性皮膚病,疾病特徵為皮膚乾燥、慢性濕疹樣皮損和明顯瘙癢,嚴重者影響生活質量。目前特應性皮炎的確切發病機制尚未完全明確,與遺傳和環境等因素關係密切。
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