WuXi Biologics Announces Manufacturing Partnership with InflaRx to Advance Gohibic for the Treatment of Certain Critically Ill COVID-19 patients

USA - English

• USA - English

• WuXi Biologics is the manufacturing partner of InflaRx for Gohibic (vilobelimab), a first-in-class monoclonal anti-C5a antibody.
• InflaRx received emergency use authorization (EUA) from the FDA for Gohibic (vilobelimab) for the treatment of certain critically ill COVID-19 patients in April 2023.
• WuXi Biologics will leverage its global manufacturing network and dual-sourcing strategy to support InflaRx in making Gohibic available to patients as quickly as possible.

WUXI, China, May 16, 2023 /PRNewswire/ -- 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.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "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."

Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented, "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."

About InflaRx

InflaRx GmbH (in Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together "InflaRx").

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de and www.Gohibic.com.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of Dec 31, 2022, WuXi Biologics is supporting 588 integrated client projects, including 17 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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SOURCE WuXi Biologics