泰福TX05乳癌藥 三期解盲成功 - 股票

By George
at 2021-02-20T15:14
at 2021-02-20T15:14
Table of Contents
原文標題:泰福TX05乳癌藥 三期解盲成功
原文連結:https://money.udn.com/money/story/5612/5263239?from=ednappsharing
s뢓d鬗摨繾똯報A
發布時間:2/20 12:36
原文內容:
中央社 記者潘智義台北20日電
泰福生技董事長趙宇天今天上午於證交所視訊記者會說明子公司生物相似藥TX05人體第三期臨床試驗,於美國時間2月19日完成主要療效指標分析,結果顯示TX05達到主要療效指標,解盲成功。
泰福生技預計今年年中向美國食品暨藥物管理局(FDA)申請藥證,搶攻美國約30億美元市場商機。
泰福生技指出,TX05三期臨床試驗設計受試人數809人,在全球多國多中心進行,受試對象是被診斷出HER2(第二型人類表皮生長因子接受體)陽性的成年女性早期乳癌患者。
趙宇天表示,解盲數據令人非常滿意,以泰福這樣規模的公司,能在3年內成功完成受試者多達800人的三期臨床試驗,實屬罕見。
泰福生技執行長陳林正也說,對泰福而言,經過多年努力,今年是收穫開始年。
泰福生物相似藥產品TX05三期臨床試驗採隨機、雙盲、平行設計,以TX05與經美國FDA核准之原廠參考藥物Herceptin比較其有效性、安全性及免疫性,主要為治療乳癌之用。依照IQVIA數據,Herceptin美國市場2019年銷售額約為30億美元。
心得/評論:
週五那根大紅k是暗示這結果嗎?
接下來的走勢會連拉幾根呢?
看看中天與合一的未來發展是?
生技 ?生計 ?生機?
必需填寫滿20字
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