澤璟製藥(688266.SH):中重度斑塊狀銀屑病治療藥獲臨牀試驗通知書
格隆匯3月5日丨澤璟製藥(688266.SH)公佈,公司於2020年3月5日收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》。本次獲批開展鹽酸傑克替尼片治療中、重度斑塊狀銀屑病患者的安全性和有效性的Ⅱ期臨牀試驗。
鹽酸傑克替尼片是公司自主研發小分子JAK激酶抑制劑新藥,目前尚未獲得國家批准上市。傑克替尼可阻斷JAK激酶/信號轉導和轉錄激活因子(STAT)的JAK-STAT信號傳導通路,從而改善免疫相關的炎症作用。經查詢和據我們瞭解,我國目前已批准3個JAK抑制劑上市,全球其它藥品監管機構已批准多個JAK抑制劑產品上市,用於包括類風濕關節炎、骨髓纖維化等適應症。對於中、重度斑塊狀銀屑病適應症,JAK抑制劑還都處於臨牀研究中。
鹽酸傑克替尼片首次提交臨牀試驗申請獲得受理的時間是2016年3月。目前已經完成健康志願者單次和多次口服鹽酸傑克替尼片或安慰劑片的隨機、雙盲、劑量遞增的耐受性、藥代動力學和食物影響研究;正在開展鹽酸傑克替尼片治療中高危骨髓纖維化患者的安全性和有效性的多中心Ⅱ期臨牀試驗、鹽酸傑克替尼片用於蘆可替尼不耐受的骨髓纖維化患者的安全性和有效性的ⅡB期臨牀試驗和評價鹽酸傑克替尼片治療重症斑禿的安全性和有效性的Ⅱ期臨牀試驗。
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