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海思科(002653.SZ):子公司獲得創新藥HSK44459片兩項新增適應症IND申請的受理通知書
格隆匯 12-30 20:29

格隆匯12月30日丨海思科(002653.SZ)公佈,公司子公司上海海思盛諾醫藥科技有限公司於近日收到國家藥品監督管理局下發的HSK44459片的《受理通知書》。

HSK44459片是公司自主研發的一個全新的具有獨立知識產權的治療銀屑病和特應性皮炎的藥物。根據國家藥品監督管理局關於發佈《化學藥品註冊分類及申報資料要求》的通吿(2020年第44號)中化學藥品註冊分類的規定,本品屬於化學藥品1類。

臨牀前研究結果表明,本品靶點明確、療效確切、安全性好,是一款極具開發潛力的小分子藥物,臨牀應用的效益/風險比高,具有廣闊的臨牀應用前景,有望成為銀屑病和特應性皮炎的有效治療藥物,解決目前臨牀用藥匱乏的難題。本次獲得受理的為銀屑病適應症和特應性皮炎適應症的臨牀試驗申請。

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