恆瑞醫藥(600276.SH):SHR-1707注射液獲批臨牀試驗
格隆匯 3 月 12日丨恆瑞醫藥(600276.SH)公佈,公司的子公司上海恆瑞醫藥有限公司近日收到國家藥品監督管理局核准簽發關於SHR-1707注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
SHR-1707注射液可以阻止β-澱粉樣蛋白斑塊的組裝或激活小膠質細胞吞噬各種形式的Aβ,從而降低AD患者腦內的Aβ水平,最終延緩患者認知功能退化並控制疾病進展。目前有多個公司的同類產品在臨牀研發階段,適應症為阿爾茨海默病。截至目前,SHR-1707相關項目累計已投入研發費用約4095萬元。
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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