澤璟製藥(688266.SH):將啟動鹽酸傑克替尼片治療重症斑禿Ⅲ期臨牀試驗
格隆匯6月30日丨澤璟製藥(688266.SH)公佈,近日,公司遞交的III期臨牀研究方案“鹽酸傑克替尼片治療重症斑禿患者的有效性和安全性的多中心、隨機、雙盲、安慰劑平行對照III期臨牀試驗(方案號:ZGJAK018)”獲得國家藥品監督管理局藥品審評中心(“CDE”)同意,公司將正式開展鹽酸傑克替尼片治療重症斑禿的III期臨牀試驗(試驗登記號CTR20211281)。
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。鹽酸傑克替尼片正在國內開展的其他臨牀研究包括:中、高危骨髓纖維化、蘆可替尼不耐受的骨髓纖維化、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、移植物抗宿主病等。
鹽酸傑克替尼片治療骨髓纖維化獲得了美國FDA的孤兒藥資格認定,並已獲得美國FDA的臨牀試驗許可。目前國內外同類作用機制藥物在斑禿適應症上均處在臨牀研究階段,均未獲得相關藥品監管機構的批准。
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