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海思科(002653.SZ):獲得創新藥HSK39004吸入混懸液IND申請受理通知書
格隆匯 05-15 18:43

格隆匯5月15日丨海思科(002653.SZ)公佈,公司子公司西藏海思科製藥有限公司於近日收到國家藥品監督管理局下發的《受理通知書》。HSK39004是公司自主研發的全新的具有獨立知識產權的靶向小分子抑制劑,臨牀擬用於氣道阻力為特徵的阻塞性肺病(如COPD、哮喘)的治療。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。

臨牀前研究結果顯示,HSK39004在離體氣管環和體內疾病模型中表現出顯著的氣道舒張和抗炎作用,且安全性良好,是一款極具開發潛力的小分子阻塞性肺病治療藥物,有望為COPD、哮喘等阻塞性肺病患者提供一種新的治療選擇。

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