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澤璟製藥(688266.SH):1類新藥鹽酸傑克替尼片獲准Ⅲ期臨牀試驗
格隆匯 01-11 17:39

格隆匯1月11日丨澤璟製藥(688266.SH)公佈,公司在吉林大學第一醫院開展了鹽酸傑克替尼片Ⅰ期臨牀試驗,在浙江大學醫學院附屬第一醫院等多家醫院開展了鹽酸傑克替尼片治療中、高危骨髓纖維化的Ⅱ臨牀試驗。中期分析結果顯示,鹽酸傑克替尼片治療中、高危骨髓纖維化患者,具有良好的有效性和安全性。

根據鹽酸傑克替尼片治療中、高危骨髓纖維化的已有臨牀試驗結果,公司向國家藥品監督管理局藥品審評中心(簡稱“CDE”)遞交了“一項隨機、雙盲、雙模擬、平行對照、多中心評價鹽酸傑克替尼片對照羥基脲片治療中高危骨髓纖維化患者的有效性和安全性的Ⅲ期臨牀試驗”方案(方案號:ZGJAK016)並獲得同意,公司已經啟動了該項臨牀試驗,正在招募患者。

鹽酸傑克替尼片是公司自主研發的小分子JAK激酶抑制劑新藥,屬於1類新藥,公司擁有該產品的自主知識產權。鹽酸傑克替尼可抑制非受體酪氨酸Janus相關激酶JAK1、JAK2和JAK3。鹽酸傑克替尼能有效的抑制JAK信號通路的激活,抑制轉錄激活因子(STAT)磷酸化,從而抑制STAT調節的下游基因表達,為原化學藥品第1.1類藥物。

目前公司正在開展鹽酸傑克替尼片的臨牀研究包括:中、高危骨髓纖維化(MF)、重症斑禿、特發性肺纖維化、強直性脊柱炎、中重度斑塊狀銀屑病、中重度特應性皮炎等。鹽酸傑克替尼用於治療骨髓纖維化的研究獲得國家“重大新藥創制”科技重大專項立項支持。

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