吉利德科学关于其在研药物Remdesivir用于应对新型冠状病毒的声明

针对冠状病毒引发的日益紧迫的疫情，2020年1月31日，吉利德科学发表了公司首席医学官Merdad Parsey医学博士的声明。该声明介绍了公司正在全力开展的药物研发方面的努力。药时代进行了编译，与感兴趣的朋友们分享。

“吉利德科学正在与全球卫生部门密切合作，以合适的方式实验性使用公司的在研化合物Remdesivir来应对新型冠状病毒2019-nCoV疫情。公司与美国食品药品监督管理局（FDA）、美国疾病控制中心（CDC）、美国卫生部（HHS）、中国CDC和中国国家药品监督管理局（NMPA）、世界卫生组织（WHO）、美国国家过敏和传染病研究所（NIAID） 以及个人研究人员和临床医生合作，专注于贡献我们的抗病毒专业知识和资源，以帮助患者和社会抗击2019-nCoV。

Remdesivir尚未在全球任何地方获得许可或批准，尚未被证明对任何用途都是安全或有效的。在没有任何获批的治疗方案的情况下，当地监管机构在权衡了使用尚无相关数据的实验药物治疗新冠状病毒患者的风险和获益之后，批准吉利德科学接受主治医师的要求而提供Remdesivir紧急治疗少数患者。

吉利德科学正在与中国卫生部门合作启动一项随机对照试验，以确定该药物是否可以安全有效地用于治疗2019-nCoV病毒。公司还将加快Remdesivir针对2019-nCoV样品的的适当的实验室研究。

尽管目前尚无Remdesivir针对2019-nCoV的抗病毒数据，但针对其它冠状病毒的可用数据给了我们希望。Remdesivir已在动物模型中被证明其对MERS病毒和SARS病毒病原体的体外和体内活性，MERS和SARS是与2019-nCoV结构相似的冠状病毒。紧急使用Remdesivir治疗埃博拉病毒感染患者的临床数据也有限。

吉利德科学致力于支持世界卫生界迅速有效地应对全球范围内严重且威胁生命的病毒爆发。”

以上为公司新闻稿中文译文。

关于Remdesivir的临床应用，2020年1月27日，《科学》（Science）杂志发表文章“Can an anti-HIV combination or other existing drugs outwit the new coronavirus?"。文章报道了相关进展，提出了Remdesivir与单克隆抗体的组合疗法有望成为新型病毒患者的治疗选择。

（图片来源：杂志官网）

2020年1月31号，《新英格兰医学杂志》（NEJM）报道了一条振奋人心的大好消息。美国的第一例2019-nCoV患者在住院第7天开始接受Remdesivir治疗，效果明显。患者第二天退烧，相关症状减轻。该临床结果对中国乃至全球抗击病毒而挽救患者都有重要的指导意义。

（图片来源：杂志官网）

真心祝愿：全球一起努力，战胜病毒，共度时艰！

药时代将继续密切关注，及时报道。

水平、时间有限，错误疏漏难免，欢迎批评指正！了解详情，请阅读公司声明的英文原文。

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.

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