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開拓藥業普克魯胺3期臨牀達主要終點,打新黨被套一年終解套
uSMART盈立智投 03-12 14:23

uSMART盈立智投3月12日消息,上市後一路陰跌,打新黨一度被深套-65%的開拓藥業-B,近4個月強勢逆襲,今日股價重新站上發行價(20.15港元)上方,盤中最高漲超12%,股價高見21.2港元。

行情來源:uSMART盈立智投APP

股價的逆襲,或源自核心藥物的研發進展順利。

開拓藥業普克魯胺治療重症新冠患者臨牀試驗死亡風險降低92%

3月11日,開拓藥業宣佈,普克魯胺在巴西進行的治療重症新冠患者的3期臨牀試驗中達到主要終點。數據顯示:普克魯胺可將重症新冠患者的死亡風險降低92%,並將平均住院時間縮短了9天。

普克魯胺治療重症新冠患者的臨牀試驗(NCT04728802)是一項多中心、隨機、雙盲、安慰劑平行對照的由研究者發起的研究,旨在探索普克魯胺治療重症新冠患者的有效性。該臨牀試驗招募約588名新冠患者,納入到“普克魯胺+標準治療”的試驗組以及“安慰劑+標準治療”的對照組。普克魯胺治療組中,患者每日口服一次300mg普克魯胺,持續14天。對照組中,患者每日服用一次300mg安慰劑,持續14天。臨牀試驗的主要終點是第14天普克魯胺治療組相對於對照組的有效性(通過WHO 8分等級量表評估)。

截止2021年3月9日,根據294名普克魯胺治療組(男性佔比56.8%,女性佔比43.2%)和296名安慰劑對照組(男性佔比57.8%,女性佔比42.2%)受試者的數據分析顯示,治療後第14天,死亡人數對照組爲141人(47.6%),普克魯胺治療組爲11人(3.7%);新增呼吸機使用人數對照組爲156人(52.7%),普克魯胺治療組爲13人(4.4%);住院天數中位時間對照組爲14天,普克魯胺治療組爲5天;出院人數對照組爲97人,普克魯胺治療組爲262人。結果表明,普克魯胺將重症新冠患者死亡發生風險降低了92%,新增呼吸機使用發生風險降低了92%,住院時間縮短了9天。

開拓藥業創始人、董事長兼首席執行官童友之博士在新聞稿中表示:“ 特別感謝Andy Goren博士、Flávio Adsuara Cadegiani博士以及巴西Samel醫院等所有參與的研究人員的辛苦付出。本次住院重症新冠患者治療的臨牀試驗是在巴西疫情非常嚴重的亞馬遜州的十二家醫院完成,受試者的病毒感染與去年完成的輕中症新冠治療的臨牀試驗大有不同,目前亞馬遜州絕大部份患者所感染的均是P1變異的新冠病毒,其感染傳播性和致死性都大幅增加。我們非常欣慰地看到普克魯胺在變異嚴重的重症治療還能夠顯著降低新冠患者的死亡率,挽救患者的生命,同時大大減少新增機械通氣和縮短患者的住院時間,緩解當地公共衛生醫療資源的緊缺。基於輕中症、重症、危重症新冠患者的突出療效,我們期待普克魯胺早日成爲臨牀上使用的新冠全方位的有效安全的治療藥物。”

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