健亞紅斑性狼瘡新藥有望成奎寧2.0 估明年 - 股票
By Liam
at 2020-07-13T20:36
at 2020-07-13T20:36
Table of Contents
健亞紅斑性狼瘡新藥有望成奎寧2.0 估明年完成臨床試驗
1.原文連結:
https://is.gd/l3b1H6
2.原文內容:
健亞 (4130-TW) 今 (13) 日召開法說會,董事長陳正表示,旗下治療紅斑性狼瘡與慢性
風濕性關節炎新藥 GV17,除已向美國 FDA 提出臨床試驗送件前諮詢 (Pre-IND) 申請外
,因該藥對心臟安全性高,可視為羥氯奎寧的進階版本,已在英國、澳洲針對新冠肺炎高
風險族群作人體臨床試驗,預計明年有初步結果。
全球都正在尋找新冠肺炎解藥,瘧疾用藥「羥氯奎寧」一度被各國列為新冠肺炎建議療法
,美國總統川普日前更爆出,已服用該藥物一段時間;不過近日遭美國 FDA、世界衛生組
織 (WHO) 相繼宣布,臨床實驗發現無法降低患者死亡率,並宣布停止試驗。
陳正指出,氯奎與羥氯奎寧會擾亂心臟的收放電活動,導致產生心律不整,與體內免疫調
節有關,而旗下開發的新藥 GV17 安全性高,引起心律不整的機率較低,雖然無法達到治
療效果,但對人體有預防作用,可視為羥氯奎寧 2.0 進階版。
陳正表示,目前該藥已針對無症狀、輕中症患者等新冠肺炎高風險族群進行人體臨床試驗
,分別在英國、澳洲收取逾 4 萬人、2000 人,預計明年可望有初步結果。
此外,針對紅斑性狼瘡與慢性風濕性關節炎的臨床試驗,日前已向美國 FDA 提出 Pre-IN
D 申請,規劃臨床試驗等開發策略,力拚今年 9 月可取得 FDA 回覆,並在明年啟動人體
臨床試驗。
3.心得/評論:
今天大逃殺唯一不死的,就是硬氣!
--
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