賽升藥業(300485.SZ):單唾液酸四己糖神經節苷脂鈉注射液獲倫理委員會審查批件
格隆匯 6 月 18日丨賽升藥業(300485.SZ)公佈,近日,公司收到暨南大學附屬第一醫院醫學倫理委員會出具的“單唾液酸四己糖神經節苷脂鈉注射液治療急性缺血性腦卒中的有效性及安全性的隨機、雙盲、安慰劑平行對照、多中心臨牀試驗”的倫理批件。
藥物名稱:單唾液酸四己糖神經節苷脂鈉注射液;劑型:注射劑;註冊分類:化藥 4類;臨牀試驗分期:IV期上市後再評價;規格:5ml:100mg;適應症:用於治療血管性或外傷性中樞神經系統損傷;帕金森氏病。
公司將嚴格按照國家藥品監督管理局藥物臨牀試驗相關規定儘快開展 IV期上市後在評價的臨牀試驗,進一步論證治療急性缺血性腦卒中的有效性及安全性的隨機、雙盲、安慰劑平行對照、多中心臨牀試驗。臨牀試驗的進程及結果具有一定的不確定性。敬請廣大投資者謹慎決策,注意防範投資風險。
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