/PRNewswire/ - WuXi Biologics (2269.HK), a premier global Contract Research Development and Manufacturing Organization (CRDMO), confirmed that its MFG8 drug substance site in Hebei cleared the FDA Pre-License Inspection supporting commercial supply of a potential blockbuster autoimmune therapy.

The seven-day FDA review performed by three inspectors examined MFG8 quality management systems and drug substance production operations. Successful completion of the inspection underscores WuXi Biologics strong regulatory compliance history while highlighting its dependable quality framework proven GMP execution strength and integrated expertise for consistent global commercial output.

MFG8 forms a key element of WuXi Biologics worldwide manufacturing footprint. Fitted with twelve 4000L single-use bioreactors the site applies the companys signature scale-out approach to deliver adaptable commercial production from 4000L up to 20000L. The facility also adopts modern sustainable building methods and advanced technologies such as digital platforms plus a rooftop photovoltaic array to drive carbon reduction resource reuse and recycling goals.

Dr. Chris Chen CEO of WuXi Biologics stated that the MFG8 FDA Pre-License Inspection success strongly validates the companys dedication to global quality and compliance benchmarks. This achievement reflects ongoing investment in a top-tier quality system and proven ability to assist partners with worldwide commercial manufacturing. The company is pleased to support delivery of this potential blockbuster autoimmune therapy to patients via its high-quality production capabilities. WuXi Biologics will keep empowering global partners through a reliable quality system and speed the availability of innovative biologics to more patients around the world.

WuXi Biologics maintains a consistent record of meeting strict industry quality requirements. By the close of 2025 the company had passed 46 regulatory inspections including 22 from the FDA and EMA while obtaining 136 facility license approvals. It also holds an industry-leading 100 percent pass rate on FDA Pre-License Inspections. In addition WuXi Biologics has completed more than 1800 GMP quality audits from global clients including over 230 by EU Qualified Persons. The firm currently runs 25 drug substance facilities and 18 drug product facilities across its global network. These world-class quality and compliance strengths support enduring client confidence worldwide.

About WuXi Biologics

WuXi Biologics (stock code 2269.HK) is a leading global Contract Research Development and Manufacturing Organization (CRDMO) that provides end-to-end solutions enabling partners to discover develop and manufacture biologics from concept through commercialization for patients worldwide.

With more than 13000 employees across China the United States Ireland Germany and Singapore including specialists in biologics R&D manufacturing technology innovation and operational excellence WuXi Biologics applies its technologies and know-how to deliver efficient cost-effective and scalable biologics solutions matched to client requirements. By integrating digital capabilities throughout the full biopharmaceutical value chain the company converts data computation and prediction into clear client experiences accelerated development intelligent operations and more efficient manufacturing. As of April 30 2026 WuXi Biologics supports 982 integrated client projects including 78 in Phase III and 25 in commercial manufacturing with complex modalities accounting for more than half of the portfolio.

WuXi Biologics views sustainability as essential to long-term growth. The company advances technology innovations to provide leading end-to-end Green CRDMO solutions for global partners while upholding strong Environmental Social and Governance practices. Dedicated to shared value creation it works with stakeholders to generate positive social and environmental outcomes and encourage responsible practices across the value chain.

For further details on WuXi Biologics please visit www.wuxibiologics.com.

The winner of the 2026 Biologics CDMO of the Year (Large CDMOs) (Life Science Connect / Outsourced Pharma)

The winner of the 2026 Best Contract Development & Manufacturing Organization Award (ABEA)

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SOURCE WuXi Biologics