澤璟製藥(688266.SH):鹽酸傑克替尼片治療重症斑禿II期臨牀試驗取得成功結果
格隆匯6月28日丨澤璟製藥(688266.SH)公吿,近日,公司自主研發的1類新藥鹽酸傑克替尼片治療重症斑禿的II期臨牀研究取得成功結果。
結果顯示,鹽酸傑克替尼片三個劑量組(50mgBID、150mgQD及200mgQD)均可明顯改善重症斑禿患者的SALT(脱髮嚴重程度評分工具)評分,改善患者的病情,各劑量組的耐受性和安全性良好。該項臨牀試驗的結果將在皮膚病學領域國際學術會議上公佈。
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。
根據國家藥品註冊相關的法律法規要求,藥品需要完成法規要求的相關臨牀試驗,並經國家藥品監督管理局批准後方可上市。
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