1月31日，吉利德發(fā)布了公司首席醫(yī)學(xué)官M(fèi)erdad Parsey博士針對(duì)2019新型冠狀病毒（2019-nCoV）正在采取的藥物研發(fā)行動(dòng)的聲明。
Merdad Parsey博士在聲明中指出：“針對(duì)2019新型冠狀病毒全球爆發(fā)這一公共衛(wèi)生事件，吉利德目前正在跟全球醫(yī)藥衛(wèi)生監(jiān)管機(jī)構(gòu)密切溝通合作，推進(jìn)開(kāi)展我們抗病毒 藥物remdesivir的臨床試驗(yàn)。吉利德愿意跟美國(guó)食品藥品監(jiān)督管理局（FDA）、美國(guó)疾病控制與預(yù)防中心（CDC）、美國(guó)健康與人類服務(wù)部（DHHS）、中國(guó)CDC、世界衛(wèi)生組織（WHO）、 美國(guó)國(guó)家過(guò)敏和傳染病研究所（NIAID）以及個(gè)人研究者和臨床醫(yī)師一起努力，將我們過(guò)往的抗病毒 藥物研發(fā)經(jīng)驗(yàn)和資源投入到這場(chǎng)戰(zhàn)役中，幫助患者和各國(guó)機(jī)構(gòu)共同抗擊2019-nCoV。
Remdesivir目前尚未在全球任何國(guó)家或地區(qū)獲得批準(zhǔn)，臨床使用的安全性或有效性也尚未得到證明。但是為了響應(yīng)臨床醫(yī)生的使用需求，以及支持部分藥監(jiān)機(jī)構(gòu)的工作，我們已經(jīng)慎重評(píng)估了提供了這個(gè)未在2019-nCoV身上取得任何數(shù)據(jù)的在研藥物的風(fēng)險(xiǎn)和獲益。吉利德已經(jīng)為少部分需要緊急救治但缺少治療藥物的患者提供了 remdesivir。
吉利德目前正在跟中國(guó)衛(wèi)生當(dāng)局密切合作，希望盡快啟動(dòng)一個(gè)隨機(jī)、對(duì)照臨床研究來(lái)確定remdesivir 能否安全有效地用于治療2019-nCoV感染。我們也正在加快進(jìn)行remdesivir抗2019-nCoV活性的實(shí)驗(yàn)室檢測(cè)。
盡管目前沒(méi)有任何數(shù)據(jù)證明remdesivir的抗2019-nCoV活性，但是remdesivir在其他冠狀病毒中顯示的活性數(shù)據(jù)給了我們信心。remdesivir在體外和動(dòng)物模型身上顯示出了較好的抗MERS和SARS病毒的活性，這些病毒跟2019-nCoV結(jié)構(gòu)相似。目前我們手上還有一些關(guān)于使用remdesivir緊急救治埃博拉病毒感染患者的臨床數(shù)據(jù)可供參考。
總之，吉利德將會(huì)快速和高效地向全球衛(wèi)生機(jī)構(gòu)提供支持，幫助應(yīng)對(duì)這場(chǎng)全球范圍內(nèi)的嚴(yán)重和威脅生命的病毒爆發(fā)危機(jī)。
remdesivir屬于核苷類似物，是RNA依賴的RNA聚合酶（RdRp)抑制劑，可以通過(guò)抑制病毒核酸合成抗病毒。目前針對(duì)埃博拉病毒感染的臨床研究進(jìn)行到了II期階段。
吉利德聲明原文如下：
Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)
Foster City, Calif., January 31, 2020 — Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences:
"Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir. Together with the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (DHHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), and the U.S. National Institute of Allergies and Infectious Diseases (NIAID), and along with individual researchers and clinicians, Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV.
Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options.
Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.
While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV. There are also limited clinical data available from the emergency use of remdesivir in the treatment of patients with Ebola virus infection.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide."
About Gilead Sciences
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
合作咨詢
肖女士
021-33392297
Kelly.Xiao@imsinoexpo.com
2006-2025 上海博華國(guó)際展覽有限公司版權(quán)所有（保留一切權(quán)利）
滬ICP備05034851號(hào)-57
