恆瑞醫藥(600276.SH):“注射用HR17020”獲批臨牀試驗
格隆匯 9 月 28日丨恆瑞醫藥(600276.SH)公佈,近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。
一、藥品基本情況
1、藥物的基本情況
藥品名稱:注射用HR17020
劑型:注射劑
申請事項:臨牀試驗
受理號:CXHL2000226
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2020年5月25日受理的注射用HR17020符合藥品註冊的有關要求,同意開展臨牀試驗。
2、藥物的其他情況
注射用HR17020擬用於預防腎病綜合徵患者血栓栓塞。經查詢,國內外尚無同類藥物獲批用於預防腎病綜合徵患者血栓栓塞。截至目前,該產品累計已投入研發費用約為657萬元。
根據我國藥品註冊相關的法律法規要求,藥物在獲得藥物臨牀試驗批准通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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