海思科(002653.SZ):創新藥環泊酚注射液Ⅲ期臨牀試驗獲倫理批准
格隆匯7月7日丨海思科(002653.SZ)宣佈,公司於2021年6月向北京大學第一醫院醫學倫理委員會遞交了關於“一項在婦科門診手術受試者中評價環泊酚注射液鎮靜/麻醉有效性和安全性的多中心、隨機、雙盲、丙泊酚平行對照的Ⅲ期臨牀研究”的臨牀相關資料,並於近日獲得倫理批件,可開始實施Ⅲ期臨牀研究。
環泊酚注射液由公司自主研發,公司擁有環泊酚注射液的專利在中國境內的獨佔實施許可權,目前擬開發婦科門診手術的適應症。根據我國《國家藥監局關於發佈化學藥品註冊分類及申報資料要求的通吿》中對化學藥品註冊分類規定,本品屬於化學藥品2.4類,為含有已知活性成分的新適應症的藥品。
環泊酚注射液目前已上市的適應症有消化道內鏡檢查中的鎮靜、全身麻醉誘導,已遞交上市申請的適應症有支氣管鏡診療的鎮靜和/或麻醉、全身麻醉誘導和維持。基於臨牀用藥需求的考慮,公司做出開展新增婦科門診手術的Ⅲ期臨牀試驗的決定。近期已獲得北京大學第一醫院的倫理批件,後期即將開展篩選入組。
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