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海思科(002653.SZ):獲得創新藥HSK45030分散片的藥物臨牀試驗批准通知書
格隆匯 07-01 18:14

格隆匯7月1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HSK45030的《藥物臨牀試驗批准通知書》。

HSK45030分散片是公司自主研發的一種口服、選擇性靶向小分子抑制劑,擬用於肌營養不良症。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,HSK45030能有效阻止肌肉功能喪失的級聯反應,防止因收縮誘導的損傷而導致的長期纖維化和脂肪組織堆積,在動物模型中展現了優異的抗肌萎縮的療效;同時也表現出了良好的耐受性和較大的安全窗,是一款極具開發潛力的藥物,有望為肌營養不良患者提供新的治療選擇。

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