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SHANGHAI, April 17, 2019 – WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today announced that its Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Wuxi city successfully completed a seven-day FDA surveillance inspection by three inspectors for the production of Trogarzo™, the first routine GMP inspection since product approval. FDA typically conducts this inspection every two years upon product approval.
The facilities passed the U.S. FDA Pre-License Inspection in 2017, as well as the European Medicines Agency (EMA) Pre-Approval Inspection in March this year. During all three inspections, there are no issues related to data integrity, which demonstrates strong expertise in addressing this regulatory requirement. The outcome of this inspection reinforces that the quality system at WuXi Biologics strictly adheres to the U.S. FDA’s GMP regulations. WuXi Biologics is the first and only Chinese biologics company to be approved by the U.S. FDA, as well as the first and only biologics company in China to be approved by EMA.
“Once again we are very proud of successfully completing the FDA inspection. It is a strong testament to our commitment in maintaining the highest global quality standards,” commented Dr. Chris Chen, CEO of WuXi Biologics, “This result provides powerful support for our unique manufacturing paradigm ‘Global Dual Sourcing within WuXi Biologics’, as we expand biomanufacturing capacity and capabilities in China, Ireland, Singapore and the U.S. WuXi Biologics will continue to advance global biomanufacturing network to ensure that biologics are manufactured at the highest quality and with a robust supply chain to enable partners and benefit patients worldwide.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2021, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.