海思科(002653.SZ):獲得創新藥HSK47388片新適應症IND申請《受理通知書》
格隆匯6月24日丨海思科(002653.SZ)公佈,近日收到國家藥品監督管理局下發的《受理通知書》,藥品名稱:HSK47388片。HSK47388片是公司自主研發的口服、強效、高選擇性的藥物,擬用於自身免疫疾病的治療。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,HSK47388在大鼠腸炎模型中劑量依賴地呈現出顯著的藥效,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,本次申請為HSK47388片在自身免疫疾病領域中又一新適應症的臨牀試驗申請,有望為自身免疫疾病患者提供一種新的治療選擇。
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