中國中藥(00570.HK):國家藥監局受理鬱樞達片的新藥註冊上市申請
格隆匯6月25日丨中國中藥(00570.HK)公吿,中國國家藥品監督管理局已受理集團附屬公司國藥集團同濟堂(貴州)製藥有限公司的1.1類中藥創新藥鬱樞達片註冊上市申請("註冊申請")。
鬱樞達片具有醒脾化濕、理氣解鬱的功效。臨牀研究證實,鬱樞達片對氣機鬱滯所致的情緒鬱悶、低落,思維遲鈍,食少納呆等症狀有顯著療效,尤其在改善抑鬱障礙早期輕型、中型症狀方面表現出色。同濟堂製藥於2024年完成了鬱樞達片用於治療輕、中度抑鬱症的III期臨牀試驗。結果顯示,鬱樞達片在治療輕、中度抑鬱症(濕濁困脾、氣機鬱滯證)受試者時,展現出良好的安全性和有效性,且療效顯著優於安慰劑組。
鬱樞達片在獲國家藥監局註冊申請受理後,將轉入藥品審評中心接受技術審評、現場核查、抽樣檢驗等一系列工作程序,完成時間、審批結果均具有不確定性。集團無法保證鬱樞達片最終將成功獲批上市。
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