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澤璟製藥(688266.SH):鹽酸傑克替尼片已遞交新藥上市申請
格隆匯 09-28 16:00

格隆匯9月28日丨澤璟製藥(688266.SH)公佈,近日,公司自主研發的1類新藥鹽酸傑克替尼片已向國家藥品監督管理局(NMPA)遞交新藥上市申請(NDA),目前等待正式受理中。

本次遞交新藥上市申請的適應症是用於治療中、高危骨髓纖維化,包括原發性骨髓纖維化(PMF)、真性紅細胞增多症後骨髓纖維化(Post-PV-MF)和原發性血小板增多症後骨髓纖維化(Post-ET-MF),這是鹽酸傑克替尼片首個遞交新藥上市申請的臨牀適應症。根據公開資料查詢,傑克替尼也是第一個申請新藥上市的國產JAK抑制劑類創新藥物。

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