WuXi Biologics Receives CDMO Leadership Awards for Eighth Consecutive Year

Rhea-AI Summary

WuXi Biologics (2269.HK) has received the 2025 CDMO Leadership Awards in the 'Biologics - Global' category for the eighth consecutive year, along with recognition for 'Best Scientific Expertise', 'Best Seamless Delivery Across Phases', and 'Best Innovative Approach to Technology and Process Execution'.

The company has achieved significant operational milestones, including:

• Reducing monoclonal antibody development time from DNA to IND to 9 months, with a recent autoimmune project completed in 6 months
• Scaling manufacturing capacity from 4,000 to 16,000 liters using single-use technology (SUT) with 99% success rate (2022-2024)
• Maintaining cost-effectiveness comparable to stainless steel systems
• Achieving 100% success in pre-approval inspections and passing over 40 global regulatory inspections, including 22 by FDA and EMA

Positive

• Achieved 99% manufacturing success rate (2022-2024)
• Reduced development timeline from DNA to IND to 9 months
• 100% success rate in regulatory pre-approval inspections
• Scaled manufacturing capacity by 4x while maintaining cost efficiency
• Passed 40+ global regulatory inspections, including 22 FDA/EMA inspections

Negative

• None.

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SHANGHAI, March 23, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has received 2025 CDMO Leadership Awards in the "Biologics - Global" category. It has also been recognized for excellence in "Best Scientific Expertise", "Best Seamless Delivery Across Phases", "Best Innovative Approach to Technology and Process Execution", making it the most lauded company in the ceremony.

This marks WuXi Biologics' eighth consecutive year receiving the CDMO Leadership Award, underscoring its commitment to advancing integrated technology platforms that accelerate biologics discovery, development, and manufacturing. It shortened the development time for monoclonal antibody projects from DNA to Investigational New Drug (IND) application to 9 months, with a recent autoimmune disease project completed in just 6 months. By leveraging single-use technology (SUT), the company scaled manufacturing from 4,000 to 16,000 liters across its global facilities, achieving a 99% success rate (2022-2024). Given the equivalent scale, the SUT manufacturing costs are comparable to those of stainless steel systems. These milestones are underpinned by its world-class quality systems, which have ensured a 100% success rate in pre-approval inspections (PAI) and have passed over 40 inspections by global regulatory agencies, including 22 conducted by the FDA and EMA.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are honored to receive the CDMO Leadership Award for the eighth consecutive year. This achievement reflects the trust of our global partners and the relentless dedication of our team. We are committed to enabling our partners in delivering life-saving treatments quickly and effectively to the market, with the aim of benefiting patients worldwide."

The CDMO Leadership Awards are presented by Outsourced Pharma and Life Science Leader. For the 2025 awards, 210 CDMOs were evaluated based on authoritative third-party research. The awards recognize top CDMOs in four categories (Biologics, Cell & Gene Therapy, Small Molecule API, Small Molecule Dosage Form) across three service regions (Global, North American, and International).

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 December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.

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

Contacts 

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PR@wuxibiologics.com 

Business
info@wuxibiologics.com

FAQ

What operational achievements did WuXi Biologics (WXXWY) report in their 2025 CDMO awards announcement?

WuXi Bio reduced antibody development time to 9 months, achieved 99% manufacturing success rate, and passed 40+ regulatory inspections including 22 FDA/EMA inspections.

How has WuXi Biologics (WXXWY) improved their manufacturing efficiency in 2022-2024?

They scaled manufacturing from 4,000 to 16,000 liters using single-use technology, maintaining costs comparable to traditional systems with 99% success rate.

What regulatory compliance track record does WuXi Biologics (WXXWY) maintain as of 2025?

100% success rate in pre-approval inspections and passed over 40 global regulatory agency inspections, including 22 from FDA and EMA.

How has WuXi Biologics (WXXWY) improved their drug development timeline in 2025?

Reduced DNA to IND development time to 9 months for monoclonal antibodies, with one autoimmune project completed in just 6 months.