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WuXi Biologics Receives CDMO Leadership Awards for Eighth Consecutive Year

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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

WuXi Biologics (2269.HK) ha ricevuto per l'ottavo anno consecutivo i CDMO Leadership Awards 2025 nella categoria 'Biologics - Global', insieme al riconoscimento per 'Migliore Esperienza Scientifica', 'Miglior Consegna Senza Soluzioni di Continuità attraverso le Fasi' e 'Miglior Approccio Innovativo alla Tecnologia e all'Esecuzione dei Processi'.

L'azienda ha raggiunto traguardi operativi significativi, tra cui:

  • Riduzione del tempo di sviluppo degli anticorpi monoclonali da DNA a IND a 9 mesi, con un recente progetto autoimmune completato in 6 mesi
  • Aumento della capacità produttiva da 4.000 a 16.000 litri utilizzando tecnologia monouso (SUT) con un tasso di successo del 99% (2022-2024)
  • Mantenimento di un'efficacia economica paragonabile ai sistemi in acciaio inossidabile
  • Raggiungimento del 100% di successo nelle ispezioni pre-approvazione e superamento di oltre 40 ispezioni regolatorie globali, comprese 22 da parte della FDA e dell'EMA

WuXi Biologics (2269.HK) ha recibido por octavo año consecutivo los CDMO Leadership Awards 2025 en la categoría 'Biologics - Global', junto con el reconocimiento por 'Mejor Experiencia Científica', 'Mejor Entrega Sin Interrupciones a Través de las Fases' y 'Mejor Enfoque Innovador en Tecnología y Ejecución de Procesos'.

La compañía ha logrado hitos operativos significativos, incluyendo:

  • Reducción del tiempo de desarrollo de anticuerpos monoclonales de ADN a IND a 9 meses, con un reciente proyecto autoinmune completado en 6 meses
  • Aumento de la capacidad de fabricación de 4,000 a 16,000 litros utilizando tecnología de un solo uso (SUT) con una tasa de éxito del 99% (2022-2024)
  • Mantenimiento de una rentabilidad comparable a los sistemas de acero inoxidable
  • Logro del 100% de éxito en inspecciones previas a la aprobación y superación de más de 40 inspecciones regulatorias globales, incluidas 22 por parte de la FDA y la EMA

우시 바이오로직스 (2269.HK)는 '생물학 - 글로벌' 부문에서 2025 CDMO 리더십 어워드를 8년 연속으로 수상했으며, '최고의 과학 전문성', '단계 간 원활한 전달', '기술 및 프로세스 실행에 대한 최고의 혁신적 접근'에 대한 인정도 받았습니다.

회사는 다음과 같은 중요한 운영 이정표를 달성했습니다:

  • DNA에서 IND까지의 단클론 항체 개발 시간을 9개월로 단축, 최근 자가면역 프로젝트는 6개월 만에 완료
  • 단일 사용 기술(SUT)을 사용하여 제조 용량을 4,000리터에서 16,000리터로 확장, 성공률 99% (2022-2024)
  • 스테인리스 강 시스템과 유사한 비용 효율성 유지
  • 사전 승인 검사에서 100% 성공 달성 및 FDA와 EMA를 포함한 40개 이상의 글로벌 규제 검사 통과

WuXi Biologics (2269.HK) a reçu pour la huitième année consécutive les CDMO Leadership Awards 2025 dans la catégorie 'Biologics - Global', ainsi que des distinctions pour 'Meilleure Expertise Scientifique', 'Meilleure Livraison Continue à Travers les Phases' et 'Meilleure Approche Innovante en Technologie et Exécution des Processus'.

L'entreprise a atteint des jalons opérationnels significatifs, notamment :

  • Réduction du temps de développement des anticorps monoclonaux de l'ADN à l'IND à 9 mois, avec un projet auto-immun récemment achevé en 6 mois
  • Augmentation de la capacité de fabrication de 4 000 à 16 000 litres en utilisant la technologie à usage unique (SUT) avec un taux de réussite de 99% (2022-2024)
  • Maintien d'une rentabilité comparable à celle des systèmes en acier inoxydable
  • Obtention d'un taux de réussite de 100% lors des inspections préalables à l'approbation et passage de plus de 40 inspections réglementaires mondiales, dont 22 par la FDA et l'EMA

WuXi Biologics (2269.HK) hat zum achten Mal in Folge die CDMO Leadership Awards 2025 in der Kategorie 'Biologics - Global' erhalten, zusammen mit Auszeichnungen für 'Beste Wissenschaftliche Expertise', 'Bester Nahtloser Übergang zwischen den Phasen' und 'Bester Innovativer Ansatz für Technologie und Prozessausführung'.

Das Unternehmen hat bedeutende operationale Meilensteine erreicht, darunter:

  • Reduzierung der Entwicklungszeit von monoklonalen Antikörpern von DNA zu IND auf 9 Monate, mit einem kürzlich abgeschlossenen Autoimmunprojekt in 6 Monaten
  • Erhöhung der Produktionskapazität von 4.000 auf 16.000 Liter unter Verwendung von Einwegtechnologie (SUT) mit einer Erfolgsquote von 99% (2022-2024)
  • Aufrechterhaltung einer Kosteneffizienz, die mit Edelstahl-Systemen vergleichbar ist
  • Erreichung einer 100%igen Erfolgsquote bei Vorabgenehmigungsinspektionen und Bestehen von über 40 globalen Regulierungsinspektionen, darunter 22 von der FDA und der 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.

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

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SOURCE WuXi Biologics

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.
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