海思科(002653.SZ):創新藥HSK7653片Ⅲ期臨牀試驗獲得倫理批准
格隆匯8月17日丨海思科(002653.SZ)宣佈,公司於近期獲得了北京大學人民醫院倫理審查委員會關於“一項在中國2型糖尿病患者中評價HSK7653片單藥治療的有效性和安全性的多中心、隨機、雙盲、安慰劑平行對照臨牀研究”批准函,可開始實施Ⅲ期臨牀研究,計劃2020年四季度開始篩選併入組患者。
HSK7653片是公司開發的全新的具有自主知識產權的治療2型糖尿病的口服藥物,擬用於2型糖尿病治療。按我國藥品註冊管理辦法規定,其藥品註冊分類為化藥1類。
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