Regeneron与BARDA续约增供埃博拉治疗药Inmazeb：约2.7亿美元、供药至2031年

总部位于美国纽约州 Tarrytown 的生物技术公司 Regeneron Pharmaceuticals（纳斯达克：REGN）10月26日宣布，已与美国卫生与公众服务部（HHS）下属战略准备与响应管理局（ASPR）的生物医学高级研究与发展局（BARDA）续签协议，为美国的埃博拉疾病防范增供其治疗药 Inmazeb，预计供药至 2031 年、合同金额约 2.7 亿美元；该协议扩展了双方始于 2020 年的原始采购合作。

Inmazeb 是由 atoltivimab、maftivimab 与 odesivimab-ebgn 三种抗体组成的鸡尾酒疗法，是首个获美国食品药品监管局（FDA）批准的埃博拉治疗药物，适用于扎伊尔型埃博拉病毒（Orthoebolavirus zairense）感染的成人与儿童患者，包括感染母亲所生的新生儿，自 2019 年以来已用于数百名患者。公司称，在临床试验中，该药在低病毒载量患者中使死亡率较活性对照治疗降低约 55%。其疗效与安全性来自 681 名患者参与的 PALM 试验，该试验于 2018 年刚果（金）疫情期间由世界卫生组织、美国国立卫生研究院与刚果（金）国家生物医学研究所独立开展；Inmazeb 于 2023 年 11 月成为首个、也是目前唯一通过世卫组织预认证的埃博拉治疗药物。

Regeneron 董事会联合主席、总裁兼首席执行官 Leonard S. Schleifer 表示：「保持 Inmazeb 的充足供应，正是这个国家为已经看得见的地平线上的威胁所需要的防范准备。」他说，这份续签协议体现了公司与 BARDA 长期合作的实力，以及双方确保埃博拉疫情一旦发生即有现成药物可用的共同承诺。

与供药协议分开，公司同日宣布，其在研的 maftivimab 单药疗法正被纳入 PARTNERS 临床试验，评估其治疗本迪布焦型（Bundibugyo）埃博拉病毒病的潜力——该毒株正驱动刚果（金）当前这轮疫情，且目前尚无获批治疗药物。maftivimab 是 Inmazeb 中中和效力最强的成分，已在体外与非人灵长类研究中显示对本迪布焦病毒的活性，相关数据已以预印本形式发布、待同行评审。PARTNERS 试验由世卫组织主办、牛津大学大流行科学研究所国际协调、刚果（金）国家生物医学研究所牵头当地实施，并获非洲疾控中心支持。据路透社报道，本轮疫情已扩散至非洲四个国家，刚果（金）已有近 1 万人感染、逾 4,800 人死亡。

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跟进：非洲疾控中心派顶尖科学家赴尼日利亚溯源埃博拉病例：患者未到过刚果（金），与肯尼亚病例或曾同在Entebbe机场

来源：GSM·美国

Regeneron Extends BARDA Agreement for Additional Supply of Ebola Treatment Inmazeb: About $270 Million Through 2031

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), based in Tarrytown, New York, announced on October 26 that it has extended its agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to provide additional supply of its Ebola treatment Inmazeb for U.S. preparedness. Regeneron expects to deliver additional treatment doses to the U.S. government through 2031 and receive payment of approximately $270 million. The agreement expands a partnership that began with BARDA's original procurement of the treatment in 2020.

Inmazeb, a three-antibody cocktail of atoltivimab, maftivimab and odesivimab-ebgn, was the first Ebola treatment approved by the U.S. Food and Drug Administration (FDA). It is indicated specifically for infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to infected mothers, and has been administered to hundreds of patients since 2019. In a clinical trial, Inmazeb reduced mortality by approximately 55 percent compared to an active control treatment in patients with low viral load. Its safety and efficacy were established in the 681-patient PALM Trial, conducted independently by the World Health Organization (WHO), the U.S. National Institutes of Health and the DRC's Institut National de Recherche Biomedicale during the 2018 outbreak in the Democratic Republic of the Congo (DRC); in November 2023, Inmazeb became the first and only Ebola treatment prequalified by the WHO.

"Maintaining a ready supply of Inmazeb is exactly the kind of preparedness this country needs for the threats we can already see on the horizon," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. "This extended agreement reflects the strength of our long-standing collaboration with BARDA and our shared commitment to ensuring that at-the-ready medicines are available whenever an Ebola outbreak occurs."

Separately, Regeneron said its investigational maftivimab monotherapy is being added to the PARTNERS clinical trial to assess its use as a potential treatment for Bundibugyo virus disease, the strain driving the current outbreak in the DRC, for which there are no currently approved treatment options. Maftivimab, the most potent virus-neutralizing component of Inmazeb, has demonstrated strong efficacy against Bundibugyo virus in in vitro and non-human primate studies, with data now available in preprint pending peer review. The PARTNERS trial is sponsored by the WHO, coordinated internationally by the University of Oxford's Pandemic Sciences Institute and led nationally in the DRC by the Institut National de Recherche Biomedicale, with support from Africa CDC. According to Reuters, the current outbreak has spread to four countries in Africa and has infected nearly 10,000 people and killed more than 4,800 in Congo.

来源：GSM·美国（原文链接）

图片来源：图：埃博拉病毒颗粒彩色扫描电子显微图（绿色颗粒自感染细胞表面芽生）。图片：美国国家过敏与传染病研究所 NIAID，CC BY 2.0，经 Wikimedia Commons。Photo: Colorized scanning electron micrograph of Ebola virus particles (green) budding from an infected cell. Image: National Institute of Allergy and Infectious Diseases (NIAID), CC BY 2.0, via Wikimedia Commons.

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