快訊/國光生技新冠疫苗一期順利完成 - 股票
By Quintina
at 2020-11-20T17:21
at 2020-11-20T17:21
Table of Contents
1.原文連結:
https://finance.ettoday.net/news/1859151?redirect=1
2.原文內容:
記者姚惠茹/台北報導
國光生技(4142)今(20)日向衛福部食品藥物管理署提出新冠疫苗二期臨床試驗申請,
將在符合主管機關二期臨床試驗人數要求和規範下,預期今年底前進入二期臨床試驗,目
標仍是希望在明年中旬提供國人防疫緊急需求的疫苗。
國光生技表示,新冠疫苗一期人體臨床試驗與台大醫院感染科合作,臨床試驗計畫主持人
為台大張上淳教授,臨床試驗收案對象為20至60歲的健康成年人,收案人數約70人,所有
受試者已完成接種,一期臨床試驗進度順利。
國光生技指出,今日正式向食藥署提出新冠疫苗二期臨床試驗申請,主要是參考主管機關
提供二期臨床試驗設計的原則和要求,並結合國光新冠疫苗研發目標,與主管機關討論出
具可行性的後續臨床試驗計畫。
國光生技說明,二期臨床試驗規劃在台灣北、中、南的合格臨床試驗醫院同步展開,而在
國際合作部分,由於台灣防疫超前部署,發病率極低,要完全在台灣執行二期臨床而能看
出疫苗保護效果恐怕有科學上的困難,因此國光也考慮與國外合作進行二期臨床試驗,目
前已在洽談中。
國光生技強調,新冠疫苗開發已與疾管署簽訂「研發COVID-19疫苗」補助計畫合約,獲得
核定經費補助一、二期共4.58億元,二期臨床試驗經主管機關核准後,預計年底進入二期
臨床試驗。
3.心得/評論:
昨天一度差點亮燈 結果今天一開盤直接沒力
下禮拜一電梯向上還下??
--
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