药明生物与德国生物制药企业InflaRx达成生产合作 加速推进新冠重症药物Gohibic

中国无锡,

2023年5月16日

全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）宣布与InflaRx（纳斯达克股票代码：IFRX）就新冠治疗药物Gohibic（vilobelimab）达成生产合作协议。InflaRx是一家总部位于德国耶拿的临床阶段生物制药公司，致力于靶向补体系统开发抗炎症疗法。FDA于2023年4月发布紧急使用授权（EUA），允许在接受有创机械通气或体外膜肺氧合后48小时内使用Gohibic治疗住院新冠重症成人患者。

根据协议条款，药明生物将为同类首创的抗C5a单克隆抗体Gohibic提供cGMP/GMP制剂生产服务。

药明生物的全球生产网络遍布美国、爱尔兰、德国，中国和新加坡，通过其先进技术和精深洞见，为客户提供高效经济的生物药解决方案，加速全球生物药的研发进程，降低成本，造福病患。

我们非常骄傲能够与InflaRx就Gohibic达成生产合作，这一合作是公司全球运营的重要里程碑。凭借我们的全球网络、精深洞见和丰富经验，我们将全力支持InflaRx快马加鞭，加速将这一治疗新药惠及广大病患。

药明生物是Gohibic项目的重要生产合作伙伴。我们非常高兴与药明生物继续合作，不惧压力，快速放量生产，确保药物供应，急患者所急。在向FDA申请紧急使用授权过程中，药明生物运用其先进技术，丰富经验，为我们提供了巨大的帮助和支持。我们期待继续与药明生物合作，让这一疗法惠及全球其他地区的更多病患。

媒体关系  PR@wuxibiologics.com

业务垂询  info@wuxibiologics.com

Wuxi, China

May 16, 2023

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the manufacturing partnership with InflaRx for its COVID-19 treatment Gohibic (vilobelimab). InflaRx, a clinical-stage biopharmaceutical company headquartered in Jena, Germany developing anti-inflammatory therapeutics by targeting the complement system, received FDA emergency use authorization (EUA) in April 2023 for Gohibic for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). 

Under the terms of the agreement, WuXi Biologics will provide cGMP manufacturing of Gohibic, a first-in-class monoclonal anti-human complement factor C5a antibody.

With a global manufacturing network that includes facilities in the United States, Ireland, Germany, China and Singapore, WuXi Biologics leverages its development and manufacturing technologies to provide more efficient and cost-effective production of drug substances (DS) and drug products (DP), delivering commercial biologics for global clients and enabling promising treatments delivered to patients worldwide.

We are proud of this manufacturing partnership with InflaRx for Gohibic. The partnership represents another remarkable milestone in our efforts to establish a robust manufacturing network on a global scale. We are fully committed to leveraging our global network, expertise and experience to make this important new treatment available as rapidly as possible to help improve the lives of many patients.

We are pleased to collaborate with WuXi Biologics as our important manufacturing partner for Gohibic. Together we will now ramp up production under high pressure to roll out supply in order to serve the patient population in need as soon as possible. With its advanced technologies and proven expertise, WuXi Biologics has helped us enormously in our application to the FDA for Gohibic's emergency use authorization. We look forward to continuing this important manufacturing partnership to potentially benefit patients in additional other areas of the world.