The seven-day FDA inspection conducted by three inspectors covered MFG8's quality management system and drug substance manufacturing processes. Passing this inspection further reinforces WuXi Biologics' outstanding regulatory compliance track record and demonstrates the company's robust and reliable quality system, proven GMP execution excellence, and integrated capabilities to support reliable global commercial manufacturing.

MFG8 is an important part of WuXi Biologics' global manufacturing network. Equipped with twelve 4,000L single-use bioreactors, the facility leverages WuXi Biologics' distinctive "scale-out" strategy to offer flexible commercial manufacturing at scales ranging from 4,000L to 20,000L. In addition, MFG8 incorporates the latest practices in sustainable construction and applies state-of-the-art technologies, including digital platforms and the rooftop photovoltaic system, to advance carbon reduction, resource reuse, and recycling.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "MFG8's successful FDA Pre-License Inspection pass is a strong testament to WuXi Biologics' commitment to global quality and compliance standards. This PLI pass reflects our sustained investment in a world-class quality system and our proven capability to support partners in advancing global commercial manufacturing. We are pleased to help bring this potential blockbuster autoimmune therapy to patients through our high-quality manufacturing capabilities. Moving forward, WuXi Biologics will continue to empower global partners with a reliable quality system and accelerate the delivery of innovative biologics to more patients worldwide."

WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility license approvals. The company also holds an industry-leading record, achieving a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. Currently, the company operates 25 drug substance facilities and 18 drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients worldwide.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.

*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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SHANGHAI, July 8, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has achieved MSCI's highest AAA ESG rating and been included in the MSCI 2026 Selection Indexes for the fourth consecutive year, underscoring global capital markets' recognition of the company's sustainability commitment and leadership in the biopharmaceutical industry.

This recognition is driven mainly by the evaluation of strong and sustained performance excellence across key ESG topics, including Product Safety and Quality, Human Capital Development, Corporate Governance and Corporate Behavior, and Climate Change. This year's rating is particularly meaningful as it was attained under MSCI ESG Model 5.0, the most significant revision since the rating system was established. Under the updated model, approximately 37% of rated issuers experienced rating changes, while WuXi Biologics successfully retained its AAA rating, demonstrating the robustness, adaptability, and long-term resilience of the company's ESG management system.

The MSCI Selection Indexes are designed to showcase the performance of companies with high ESG ratings relative to their sector peers. They are built especially for institutional investors seeking companies with a strong sustainability profile and a relatively low tracking error in relation to the underlying equity market. According to MSCI, the ETFs and ETF assets linked to the MSCI Sustainability and Climate Change indexes rank in the top globally among others.

Dr. Chris Chen, WuXi Biologics CEO and Chairman of the ESG Committee, commented, "We are honored to have once again achieved MSCI's highest AAA rating and been included in the MSCI Selection Indexes for the fourth consecutive year. This achievement validates our sustained efforts and continuous progress in sustainability. As a global leader in Green CRDMO, we consistently deliver ESG excellence, enable clients worldwide to fulfill their ESG commitments, and work with all stakeholders to promote responsible practices throughout the entire value chain."

Over the years, WuXi Biologics' consistent efforts to promote sustainable development have received notable recognition from leading global ESG rating agencies, including the EcoVadis Platinum Medal; a listing in Dow Jones Best‑in‑Class World Index and Emerging Markets Index; "A List" status from CDP for Climate Change, Water Security, and Supplier Engagement Assessment; the highest negligible-risk rating by Morningstar Sustainalytics, and designation as a Sustainalytics industry and regional ESG Leader; inclusion in the FTSE4Good Index Series; a "Prime" designation from ISS ESG Rating; and inclusion in the Hang Seng Corporate Sustainability Benchmark Index.

DISCLAIMER STATEMENT

THE INCLUSION OF WUXI BIOLOGICS IN ANY MSCI INDEX, AND THE USE OF MSCI LOGOS, TRADEMARKS, SERVICE MARKS OR INDEX NAMES HEREIN, DO NOT CONSTITUTE A SPONSORSHIP, ENDORSEMENT OR PROMOTION OF WUXI BIOLOGICS BY MSCI OR ANY OF ITS AFFILIATES. THE MSCI INDEXES ARE THE EXCLUSIVE PROPERTY OF MSCI. MSCI AND THE MSCI INDEX NAMES AND LOGOS ARE TRADEMARKS OR SERVICE MARKS OF MSCI OR ITS AFFILIATES.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.

*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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PR@wuxibiologics.com

Based on the five-day inspection, MFG2, DP1 and DPPC successfully passed ANVISA's assessment with zero findings. The inspection results demonstrate WuXi Biologics' robust quality management system, mature GMP execution, and efficient cross-functional collaboration, while verifying the company's comprehensive capabilities to support client needs for global commercial manufacturing and supply.

Within WuXi Biologics' global GMP manufacturing network, MFG2, DP1 and DPPC collectively provide integrated, end-to-end capabilities spanning large-scale biologics drug substance manufacturing, clinical and commercial drug product fill-finish, and customized packaging, meeting regulatory requirements across major markets worldwide. Together, these capabilities enable seamless manufacturing and reliable commercial supply for innovative biologic therapies.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Receiving ANVISA GMP certification reflects WuXi Biologics' continued commitment to global quality and compliance standards, and further validates our international standards across facilities, quality systems, and GMP execution. Looking ahead, we will continue to leverage our world-class quality system and end-to-end manufacturing capabilities to enable clients' global commercialization strategies, including entry into Latin America. By accelerating the delivery of high-quality, affordable biologics, we are helping to broaden access to innovative biologics for patients around the world."

WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility license approvals. The company also holds an industry-leading record, achieving a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients worldwide.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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. 

*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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Business
info@wuxibiologics.com 

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PR@wuxibiologics.com

To meet the diverse needs of projects at different development stages, MFG17 is equipped with multiple single-use bioreactors (SUBs), with a total manufacturing capacity of 9,000 liters for 80-100 batches annually. While adhering to global regulatory requirements, MFG17 offers both flexibility and process adaptability, supporting a wide variety of process modes, including fed-batch, N-1 perfusion, perfusion, intensified perfusion, and fully automated continuous manufacturing. These capabilities enhance operational efficiency and process productivity, while enabling robust scale-up and reliable supply for complex biologics.

MFG17 is also advancing its digitalization strategy by systematically implementing automation, digital technologies, and advanced infrastructure across the manufacturing value chain. By transforming data, computation, and predictive modelling capabilities into smarter operational management and higher production efficiency, providing clients cost-competitive manufacturing solutions.

The facility will work in close synergy with other operations at the Fengxian site, accelerating end-to-end integration from discovery to development, from clinical to commercial manufacturing, from drug substance to drug product, enabling faster and more efficient project delivery.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "The successful completion of the first GMP production at MFG17 further strengthens our manufacturing capabilities. Leveraging highly flexible single-use technologies and continuously advancing digital capabilities, we not only provide high-quality manufacturing support for our customers, but also serve as an extension of their capabilities, empowering global partners to accelerate the delivery of innovative biologics to patients worldwide."

WuXi Biologics continues to enhance its global dual-sourcing strategy to support technology transfer, scale-up, and multi-regional registration, providing long-term, reliable, and resilient commercial supply. The company operates across China, the United States, Ireland, Germany, and Singapore, with 5 research centers, 10 development centers, and 18 manufacturing sites, including 25 drug substance facilities and 18 drug product facilities currently in operation, providing end-to-end integrated solutions and services for global partners.

As of 2025, WuXi Biologics has delivered over 2,350 drug substance batches and over 2,260 drug product batches, and passed 46 regulatory inspections worldwide, including 22 inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), with a 100% success rate, no critical findings, and no data integrity issues. In an additional demonstration of consistent high-quality delivery across its global network, the company has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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. 

*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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info@wuxibiologics.com 

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PR@wuxibiologics.com

The inspection supported the European Union marketing authorization application for a total of 19 biologics from 13 clients, with the majority developed and manufactured on WuXi Biologics' integrated platform. These products span a range of biologics modalities, including antibodies, enzymes, and fusion proteins. The EMA inspection focused on biosafety quality control testing for cell banks and commercial unprocessed bulk associated with these products.

GMP-compliant biosafety quality control testing of commercial unprocessed bulk is a key part of pre-license inspections for biologics seeking marketing authorization in the European Union and remains a focus in routine inspections of commercial products. The four-day inspection covered areas such as quality management, facilities and equipment, testing methods, standard operating procedures, computerized systems and personnel. The Suzhou facility's quality system, infrastructure, technical capabilities, data integrity and organizational management were highly recognized by the EMA.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "From preliminary safety validation at cell bank and harvest stages to final quality control at commercial batch release, biosafety testing spans critical stages across the entire lifecycle of biologics, ensuring compliance with rigorous regulatory requirements from development through commercialization. We remain committed to maintaining a high-quality system aligned with global GMP standards as a cornerstone to ensure product quality. This capability is consistently demonstrated and implemented across our global network, reflecting our long-standing commitment to enabling our partners and ultimately benefiting patients worldwide."

WuXi Biologics' Biosafety Testing Center has two facilities in Suzhou and Shanghai, offering comprehensive services including cell bank characterization for CHO, HEK293, and E. coli expression systems, diverse biologics biosafety testing, GMP-compliant release testing for commercial products, and GLP-compliant viral clearance studies supported by high-quality in-house virus production platform. As of December 2025, WuXi Biologics' Biosafety Testing Center has successfully enabled over 1,700 IND or BLA applications. Its high-quality system and technical capabilities have been widely recognized by global regulatory authorities and clients.

In additional to EMA, WuXi Biologics' Biosafety Testing Center has received multiple recognitions from other global regulatory authorities. It has successfully completed remote interactive evaluation by the U.S. Food and Drug Administration (FDA), and has passed inspections by China National Accreditation Service for Conformity Assessment (CNAS), National Medical Products Administration (NMPA), Health Canada (HC), the Therapeutic Goods Administration (TGA) of Australia, and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, as well as more than 510 quality audits conducted by global clients.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.

*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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info@wuxibiologics.com

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PR@wuxibiologics.com

The company was shortlisted across eight award categories, reflecting the breadth of capabilities and achievements demonstrated by its Ireland site. Among the honors received, WuXi Biologics' Manufacturing Science & Technology (MSAT) Team was named Life Sciences Team of the Year and subsequently selected for the Overall Excellence in Life Sciences award, recognizing the team's exceptional contributions to advancing manufacturing science, technology transfer, operational performance, and delivery excellence.

The recognition further reinforces WuXi Biologics Ireland's position as a strategic hub within the company's global network and highlights its continued commitment to quality, innovation, operational excellence, and sustainable growth. As demand for high-quality biologics manufacturing continues to grow, the Ireland site remains focused on delivering flexible and reliable solutions that support global clients across the development and commercialization lifecycle.

These latest honors build upon a series of major milestones achieved by the Ireland site in recent years, including HPRA GMP authorization and EMA approval for commercial manufacturing of innovative biologic products. Since commencing operations, the WuXi Biologics Ireland site has established itself as one of Europe's most advanced single-use biologics manufacturing facilities, earning international recognition for its operational excellence, innovation, and sustainability performance.  

Other accolades the Ireland site has received include the ISPE Facility of the Year Award and the Operational Excellence in Life Sciences Award. All together, these achievements underscore the site's growing role in supporting global biologics development and commercial manufacturing while contributing to the continued advancement of Ireland's thriving life sciences ecosystem.

WuXi Biologics' global manufacturing footprint spans China, the United States, Ireland, Germany, and Singapore, with 24 drug substance (DS) facilities and 18 drug product (DP) facilities currently in operation. This network provides integrated dual-sourcing solutions spanning DS and DP — from clinical development through commercial-scale manufacturing — at the highest levels of quality. As of 2025, WuXi Biologics had successfully passed 46 regulatory inspections worldwide, including 22 conducted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), achieving a 100% success rate with no critical findings and no data integrity issues.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.

*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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info@wuxibiologics.com 

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PR@wuxibiologics.com

Located on a 13.5-hectare site in Tuas Biomedical Park, the Hub will be the first of its kind in Singapore, built on WuXi Biologics' proprietary technology platforms and industry-leading capabilities to offer dual sourcing solutions for biopharmaceutical companies worldwide. The Hub will add 120,000 liters of manufacturing capacity to the Company's global network, reinforcing Singapore's position as a leading biopharmaceutical hub. On this site, WuXi Biologics' subsidiary WuXi XDC achieved mechanical completion of its Singapore ADC production site in 2025.

Spanning approximately 30,000 square meters, the modular DP facility will feature advanced manufacturing lines, centralized Quality Control (QC) labs for full release and stability testing, and Manufacturing Science and Technology (MSAT) labs, significantly expanding the Company's end-to-end DP capabilities. With three pre-filled syringe (PFS) lines and two vial lines for liquid and lyophilized products, it will deliver integrated DP manufacturing for multiple dosage forms across clinical and commercial stages. The facility will also incorporate green technologies, including solar panels and an advanced system for energy monitoring and analysis, reflecting WuXi Biologics' commitment to sustainability. Operations are expected to commence in 2027.

Dr. Chris Chen, CEO of WuXi Biologics, said, "We are excited to celebrate another major milestone for our Singapore CRDMO hub. This achievement further reinforces our ability to provide global biopharmaceutical companies with a resilient and geographically diversified supply chain, one built on our world-class quality systems, cutting-edge innovation, and operational excellence. At the same time, we are dedicated to contributing to the local community in Singapore and the long-term development of its biopharmaceutical industry."

Construction across the Singapore CRDMO hub continues to advance, with the drug substance facility currently in the design phase. The Hub marks a significant step in WuXi Biologics' global extension and its long-term commitment as the partner of choice for global biopharmaceutical companies.

WuXi Biologics' global manufacturing footprint spans China, the United States, Ireland, Germany, and Singapore, with 24 drug substance (DS) facilities and 18 drug product (DP) facilities currently in operation. This network provides integrated dual-sourcing solutions spanning DS and DP, from clinical development through commercial-scale manufacturing. As of 2025, WuXi Biologics had successfully passed 46 regulatory inspections worldwide, including 22 conducted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), achieving a 100% success rate with no critical findings and no data integrity issues.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore, including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence, WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

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.

*The winner of the "2026 Biologics CDMO of the Year" (Large CDMOs)

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

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info@wuxibiologics.com

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PR@wuxibiologics.com

The CDP SEA A List represents the highest level of performance in corporate environmental transparency and supply chain climate action. In 2025, more than 23,000 companies, cities, states and regions disclosed environmental data through CDP.

WuXi Biologics actively engages with suppliers to address Scope 3 emissions through a structured approach, including risk assessments, audits, training, incentive programs, as well as Scope 3 data disclosure and target tracking, driving continuous improvement across the value chain and supporting strong supplier engagement performance.

The company's climate strategy is underpinned by Science Based Targets initiative (SBTi)-approved near-term and net-zero greenhouse gas (GHG) emissions reduction targets, including a commitment to achieve net-zero emissions across the value chain by 2050.

Dr. Chris Chen, CEO of WuXi Biologics and Chairman of its ESG Committee, commented, "We are honored to be named to CDP's Supplier Engagement Assessment A List for the second consecutive year. This achievement reflects our continued efforts to strengthen supplier collaboration and enhance value chain sustainability. As a global leader in Green CRDMO, we remain committed to working closely with all stakeholders to drive long-term sustainable growth."

Over the years, WuXi Biologics' consistent efforts to promote sustainable development have received notable recognition from leading global ESG rating agencies, including MSCI AAA Ratings; EcoVadis Platinum Medals; a listing in Dow Jones Best‑in‑Class World Index and Emerging Markets Index; the highest negligible-risk rating by Morningstar Sustainalytics, and designation as a Sustainalytics industry and regional ESG Leader; inclusion in the FTSE4Good Index Series; a "Prime" designation from ISS ESG Rating; and inclusion in the Hang Seng Corporate Sustainability Benchmark Index.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.
*The winner of the "2026 Biologics CDMO of the Year" (Large CDMOs)

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

Contacts

ESG
esg@wuxibiologics.com

Media
PR@wuxibiologics.com

Designed and built to meet international regulatory standards, DP15 delivers the flexibility and operational efficiency required for clinical-stage programs. The facility is equipped with advanced isolator-based aseptic filling lines, enabling both liquid and lyophilized drug product (DP) manufacturing, and features multiple advanced capabilities — including 100% fill weight check, nitrogen overlay, and low-temperature loading for lyophilization. Fill-finish solutions are provided for a variety of vial sizes, ranging from 2R to 20R. Fully integrated with surrounding site operations, DP15 is positioned to further accelerate the transition from development to GMP manufacturing, and drive faster, more efficient delivery for client programs.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "The successful GMP release of DP15 further strengthens our integrated delivery capabilities from drug substance to drug product. Leveraging our global CRDMO network, we will continue to enable clients to shorten technology transfer timelines, enhance execution efficiency, and advance key development milestones, ultimately accelerating the delivery of innovative biologics to patients worldwide."

These capabilities are built upon WuXi Biologics' well-established, globally integrated service platform. The company operates across China, the United States, Ireland, Germany, and Singapore, with 5 research centers, 10 development centers, and 18 manufacturing sites, including 24 drug substance facilities and 18 drug product facilities currently in operation, providing end-to-end integrated solutions and services for global partners. By the end of 2025, WuXi Biologics has delivered over 2,350 drug substance batches and over 2,260 drug product batches, and passed 46 regulatory inspections worldwide, including 22 inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), with a 100% success rate, no critical findings, and no data integrity issues. In addition, the company has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons, demonstrating consistent high-quality delivery across its global network.

WuXi Biologics has established a comprehensive and robust drug product capability to address the evolving needs of biologics across clinical development and commercial-scale manufacturing. Leveraging its global network and advanced technologies, including the WuXiHigh™, hyaluronidase co-formulation, and large-volume device solutions, the company offers a full range of delivery formats, including liquid and lyophilized vial formulations, pre-filled syringes (PFS), dual-chamber cartridges (DCC), and a variety of safety and automated combination products. These capabilities are supported by coordinated operations across multiple global sites, spanning Wuxi, Suzhou, Shanghai, Hangzhou, Chengdu, Singapore, and Cranbury (New Jersey, USA).

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.

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With the theme "Ignite Future: CRDMO Day Tokyo 2026," the gathering convened senior executives and experts from WuXi Biologics for in-depth dialogues with its Japanese partners. Discussions spanned the latest market insights and industry dynamics, integrated solutions for complex modalities, CMC best practices and manufacturing excellence. Together, the sessions highlighted not only the opportunities emerging in Japan's biopharmaceutical industry but also the breadth and depth of WuXi Biologics' capabilities in supporting them.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "Backed by deep expertise and an established track record, we look forward to deepening our collaboration with Japanese biopharmaceutical companies across the full lifecycle of a molecule, from research and development through to manufacturing, especially in the complex modalities where Japan is at the forefront of global innovation. We will continue to invest in the capabilities and talent required to support that vision over the long term, positioning ourselves as a trusted partner in shaping Japan's biopharmaceutical future."

That commitment is underwritten by a global platform built for scale and complexity. WuXi Biologics continues to advance its "Global Dual Sourcing" strategy and to strengthen its integrated CRDMO capabilities, while extending its manufacturing footprint across the United States, Ireland, Germany, China, Singapore, and Qatar.

WuXi Biologics is the partner of choice for global biotech innovators and multinational pharmaceutical companies. Between 2018 and 2025, 90 client assets supported by WuXi Biologics were licensed or acquired by large pharmaceutical companies, and 100% of clinical-stage assets were retained with WuXi Biologics through to commercial launch. It is underpinned by a unified quality system across all sites: by the end of 2025, WuXi Biologics had successfully passed 46 regulatory inspections, including 22 by the U.S. FDA and EU EMA, alongside multiple inspections by Japan's PMDA.

Complex modalities are reshaping the biopharmaceutical industry, and WuXi Biologics stands at the forefront. Today, more than half of its integrated projects are complex modalities. Bispecific/multi-specific antibodies and ADCs are growing fastest, each by nearly 30% last year. This focus positions WuXi Biologics as an ideal partner for Japan's next wave of biopharmaceutical innovation and aligns directly with the priorities of the country's leading biopharmaceutical companies.

Alongside CRDMO Day, WuXi Biologics exhibited at the 28th Interphex Week (Booth Number: Hall 3, #14-46), Japan's largest annual pharmaceutical and biotechnology trade show, where its teams met with leading biopharmaceutical companies and industry professionals throughout the week to discuss ongoing and prospective collaborations.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore – including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence – WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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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Through S&P Global's Corporate Sustainability Assessment (CSA), the DJ BIC World Index and the DJ BIC Emerging Markets Index identify sustainability leaders that rank in the top 10% based on their long-term economic, environmental and social performance, selecting from the largest 2,500 global companies in the S&P Global Broad Market Index (BMI) and from the largest 800 companies across 20 emerging markets, respectively.

Based on the 2025 CSA, WuXi Biologics ranked among the top 1% globally within its industry and was included in the S&P Global Sustainability Yearbook for the fourth consecutive year.

Dr. Chris Chen, CEO of WuXi Biologics and Chairman of its ESG Committee, commented, "We are honored to be included in both the DJ BIC World Index and the DJ BIC Emerging Markets Index. This recognition reflects our long‑term commitment to sustainability and the continuous enhancement of our overall performance across environmental, social and governance dimensions. As a global leader in Green CRDMO, WuXi Biologics continues to integrate ESG into its business strategy and operations, delivering innovative end‑to‑end solutions to our global partners. Going forward, we will keep pushing industry boundaries, collaborating with all our stakeholders to promote responsible and sustainable practices throughout the entire value chain."

Over the years, WuXi Biologics' consistent efforts to promote sustainable development have received notable recognition from leading global ESG rating agencies, including MSCI AAA Ratings; EcoVadis Platinum Medals; "A List" status from CDP for Climate Change, Water Security, and Supplier Engagement Assessment; the highest negligible-risk rating by Morningstar Sustainalytics, and designation as a Sustainalytics industry and regional ESG Leader; inclusion in the FTSE4Good Index Series; a "Prime" designation from ISS ESG Rating; and inclusion in the Hang Seng Corporate Sustainability Benchmark Index.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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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HONG KONG, April 29, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the release of its 2025 Sustainability Report. The report highlights the Company's continued commitment to placing sustainability at the core of its strategy, empowering global clients, advancing innovative biologics to benefit patients worldwide, and creating long-term value for all stakeholders.

Dr. Chris Chen, CEO of WuXi Biologics and Chairman of its ESG Committee, commented, "At WuXi Biologics, we believe that long-term business success is built on our responsibility to people, society, and the planet. As a recognized leader in sustainability, we are committed to working collaboratively with all stakeholders to create positive social and environmental impacts, empowering our global clients through end-to-end Green CRDMO solutions, and driving responsible practices across the entire value chain."

Enhancing Governance Transparency and Effectiveness

Guided by a comprehensive sustainability strategy, WuXi Biologics has put in place robust corporate governance structures and well-defined management processes. In alignment with the United Nations Sustainable Development Goals, the company has established science-based, measurable ESG target matrix supported by a detailed roadmap to monitor performance and enable continuous improvement.

WuXi Biologics is committed to open and transparent engagement with stakeholders, and to building long-term, trusted partnerships. As an active participant of the Pharmaceutical Supply Chain Initiative (PSCI), the Company adheres to PSCI principles across Ethics, Human Rights and Labor, Health and Safety, Environment, and Management Systems, and collaborates with global suppliers to promote responsible practices. In 2025, WuXi Biologics achieved ISO 20400 Sustainable Procurement certification, further strengthening supply chain resilience. The Company has established a comprehensive, end-to-end framework to protect intellectual property, trade secrets, and data privacy through institutional, technical, and managerial safeguards, ensuring effective implementation across operations. Meanwhile, the Company continues to enhance its business resilience and risk management capabilities by achieving ISO 22301 Business Continuity Management System certification, supporting stable global operations and public health responses.

Empowering People and Creating Shared Value with Communities

WuXi Biologics highly values the contributions of its global workforce and is proud of its diverse, highly professional talent base representing 51 nationalities. The Company actively supports the career development of women in Science, Technology, Engineering and Mathematics (STEM), with 54% of STEM positions held by female employees, significantly exceeding the industry average.

Community engagement remains a vital component of WuXi Biologics' positive social impact. In 2025, employees contributed over 12,000 volunteer hours in local communities. The Company also promoted closer alignment between employee engagement and community needs by mobilizing volunteer efforts in community initiatives, contributing to greater social resilience.

Driving Equitable Access to Healthcare through Technology and Innovation

By shortening the timeline from molecules to patients, we enable innovative biologics to reach patients faster, at greater scale, and with consistent quality — driving equitable access to healthcare worldwide. Through the establishment of a global, large‑scale, end‑to‑end integrated CRDMO platform, the Company continues to create long‑term value in support of global healthcare equity and improved public health outcomes.

Building on its core technology capabilities, WuXi Biologics actively responds to global public health needs by empowering partners to accelerate the development and manufacturing of innovative therapies for patients around the world. In 2025, the Company has partnered with Instituto Butantan and Fundação Butantan in Brazil to support the scaled commercial manufacturing for the dengue vaccine Butantan-DV, contributing to the strengthening of local public health preparedness. The fill-and-finish facility serving this project has received GMP certification from the Brazilian Health Regulatory Agency (ANVISA).

Rare diseases remain a key focus of the Company's platform‑based innovation. As of the end of 2025, there were 23 rare disease projects on our platform. In May 2025, partner CANbridge Pharmaceuticals received approval from the National Medical Products Administration (NMPA) for velaglucerase-beta for injection (Gaurunning^®), marking a significant milestone in advancing innovative rare disease therapies through collaboration.

In addition, the Company is committed to supporting community health through a range of initiatives, including emergency relief, primary healthcare rebuilding, disease assistance, and community health programs, continuously strengthening local healthcare systems and extending healthcare accessibility to the "last mile".

From global public health response to individual care, WuXi Biologics leverages its integrated technology platforms, resilient global network and unified world‑class quality systems to continuously enhance healthcare accessibility, safeguarding the health and well-being of patients worldwide.

Accelerating Actions for Tackling Climate Change and Promoting Environmental Stewardship

The Company continues to enhance environmental stewardship across climate change mitigation, resource efficiency, circular economy practices, ecosystem protection and green innovation.

In 2025, WuXi Biologics introduced a new and ambitious greenhouse gas emission target matrix that was validated by the Science Based Targets initiative (SBTi). The Company also achieved its water management target of reducing water consumption intensity by 30% from the base year 2019 and rolled out its Water Excellence Stewardship program across 10 sites. To support broader industry sustainability, WuXi Biologics published the Green CRDMO White Paper, detailing its green research, development and manufacturing practices, and highlighting energy-saving and carbon-reduction outcomes enabled by green operations.

To drive continuous improvement for operational excellence, WuXi Biologics Business System (WBS) applies lean management principles and integrates with sustainability strategy. In 2025, over 95% of WBS Kaizen projects generated measurable ESG benefits, including reductions in carbon emission, water consumption and waste generation.

Global Impact, Shared Future

WuXi Biologics' consistent efforts to promote sustainable development have received notable recognition from leading global ESG rating agencies. These recognitions include an MSCI AAA ESG rating; an EcoVadis Platinum Medal; inclusion in the Dow Jones Best-in-Class Indices (formerly Dow Jones Sustainability Indices); CDP "A List" status for Climate Change, Water Security, and Supplier Engagement Assessment; the highest negligible-risk ESG rating by Sustainalytics; inclusion in the FTSE4Good Index Series; a "Prime" designation from ISS ESG Corporate Rating; and inclusion in the Hang Seng Corporate Sustainability Benchmark Index.

Dr. Chris Chen commented, "Looking ahead to 2026 and beyond, we will build on our strong momentum to accelerate growth, driven by robust research, development and manufacturing capabilities. With sustainability at the core of how we innovate, operate, and grow, WuXi Biologics will continue to empower global clients to bring life-changing therapies to patients worldwide, while delivering long-term value and shared success for all stakeholders in pursuit of a healthier future."

Download 2025 Sustainability Report

https://www.wuxibiologics.com/wp-content/uploads/E_898490_WUXI-BIO_ESG2025_0429_1713_ESS.pdf 

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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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The microbial manufacturing site, broke ground last June in Wenjiang District of Chengdu, spans approximately 95,000 square meters and is designed for commercial drug substance (DS) and drug product (DP) manufacturing of microbial-derived biologics. A broad spectrum of next-generation therapies, including ADCs, cell therapies, bi-/multi-specific antibodies, and cancer vaccines, leverage recombinant proteins such as polypeptides, enzymes, antibody fragments, nanobodies, and cytokines. These recombinant proteins can be manufactured at scale through microbial fermentation, supported by compatible downstream purification and formulation processes. Microbial fermentation is gaining broad adoption across emerging biologic modalities, driven by its advantages in yield, development speed, scalability, process consistency, and cost efficiency.

Upon completion, the manufacturing site will be equipped with a 15,000 L fermenter, enabling up to 110 DS batches annually, with long-term expansion potential up to 60,000 L. It will also feature China's first dual-chamber lyophilization production line, jointly established with VISEN Pharmaceuticals, along with a vial-filling line that offers commercial DP manufacturing capacity of more than 10 million vials per year, further enhancing its commercial manufacturing capabilities for complex formulations.

In addition, the manufacturing site incorporates integrated automation and digital systems across upstream and downstream operations to support reliable GMP manufacturing, strengthening compliance, operational efficiency, and data integrity. ESG concepts are also embedded into the site's design through green building practices such as sponge city design and the adoption of photovoltaic (PV) modules, enhancing overall resource and energy efficiency.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "The structural completion of our Chengdu microbial manufacturing site represents an important step forward in strengthening our commercial-scale microbial capabilities. Designed to facilitate efficient technology transfer and reliable commercial supply, the site reflects the growing adoption of microbial technologies across emerging modalities and advanced therapies. Combined with our research, development and clinical manufacturing capabilities in Shanghai and Hangzhou, we can provide end‑to‑end CRDMO service from strain development through commercial manufacturing for global pharmaceutical innovators."

Powered by its proprietary E. coli expression system EffiX™, WuXi Biologics achieves recombinant protein titers of up to 15 g/L and delivers a complete CMC package from plasmid DNA to IND filing within six months. Its microbial platform also features a multi‑tier capacity supporting production scale‑up from 15 L, 3000 L to 15,000 L, precisely aligned with preclinical, clinical, and commercial needs. By the end of 2025, WuXi Biologics' integrated microbial fermentation platform has successfully supported the development and manufacturing of 128 molecules.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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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During the five‑day on‑site inspection, all three facilities successfully passed the MFDS assessment with no critical or major findings, reaffirming WuXi Biologics' robust quality and compliance systems, as well as its proven capability to execute GMP‑compliant large-scale manufacturing for complex biologic programs.

Within WuXi Biologics' global GMP manufacturing network, MFG5, DP2 and DPPC collectively provide integrated, end‑to‑end capabilities spanning drug substance manufacturing, drug product fill‑finish, and customized packaging, enabling efficient commercial supply of innovative biologic therapies.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Receiving GMP certification from the MFDS demonstrates our continued commitment to the global standards of quality and regulatory compliance. It further strengthens our support for customers across South Korea and the Asia‑Pacific region, while reaffirming our proven domain expertise and systematic strengths in the development and commercial manufacturing of complex biologics, including bispecific antibodies. We will continue to build on our world‑class quality system and end‑to‑end manufacturing capabilities to enable partners to accelerate the delivery of innovative biologics to patients worldwide."

WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility license approvals. The company also holds an industry-leading record, achieving a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients worldwide.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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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SHANGHAI, April 15, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has successfully achieved ISO 13485:2016 Medical Device Quality Management System certification with zero non-conformities, becoming among the first in China's drug-device combination products sector to obtain this certification. The achievement highlights the company's robust quality system and strong compliance capabilities, reflecting a solid foundation for delivering safe, stable and reliable end-to-end services to clients worldwide.

ISO 13485:2016 is widely recognized as the global gold standard for quality management in the medical device industry. It provides a structured framework to ensure safety, effectiveness and regulatory compliance across the full product lifecycle. The standard spans core elements — such as design and development, risk management, manufacturing process control, traceability, and supplier management — and emphasizes alignment with applicable regulatory requirements. Given the cross-disciplinary nature of drug-device combination products, their development and manufacturing must meet both the stability requirements for active pharmaceutical ingredients and the performance requirements for medical devices. Building on its existing cGMP framework, WuXi Biologics established a combination-product system that is aligned with both pharmaceutical and medical device regulatory expectations.

During the nearly five-day on-site audit, WuXi Biologics demonstrated a strong systems foundation and a comprehensive quality management approach for drug-device combination products, successfully obtaining certification and proving the robustness of its platform for commercial manufacturing.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Successfully achieving ISO 13485 certification reflects our technical depth and disciplined quality management for drug–device combination products. We will continue to uphold rigorous quality standards and reliable operations to deliver safe, efficient and high-quality solutions for global clients, empowering the development of breakthrough therapies through a trusted CRDMO platform."

WuXi Biologics has continuously strengthened its sustainability and compliance management systems, building an integrated framework that encompasses information security, business continuity, quality management, environmental and occupational safety, energy management, and sustainable procurement. The company has obtained multiple internationally recognized certifications — including ISO/IEC 27001, ISO 22301, ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 14064 and ISO 20400 — that verify the strength of WuXi Biologics' foundation for high-quality and sustainable growth.

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore, including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence, WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, while complex modalities represent more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are honored to receive the CDMO Leadership Award for the ninth consecutive year. This recognition reflects the continued trust of our global partners and the dedication of our more than 13,000 employees worldwide. By advancing integrated technology platforms, manufacturing excellence, and digital innovation, we remain committed to helping our partners accelerate development, ensure quality and scalability, and bring life‑saving biologics to patients worldwide."

As of the end of 2025, WuXi Biologics has 945 integrated projects on its platform, making it one of the world's largest portfolios of complex biologics. Among them, more than 50% are complex modalities, such as bi-/multi-specific antibodies and ADCs. Supported by innovative technology platforms, deep accumulated know‑how in molecule and process development, and a leading global quality system, WuXi Biologics' timelines from DNA to IND and from IND to BLA have been shortened to 6 months and 15 months, respectively, compared with industry averages of 10–12 months and 24–36 months. From technology transfer to PPQ, the standard timeline is 6 months, with an accelerated timeline of 3.5 months —compared with industry timelines of over 12 months.

WuXi Biologics has developed a holistic strategy to deliver scalable and agile manufacturing solutions that help global clients address evolving market demand. These include the application of large‑volume single‑use bioreactors (SUBs) ranging from 2,000 L and 4,000 L to 5,000 L; the combination of multiple SUBs to enable large‑scale manufacturing of up to 16,000 L; the implementation of innovative intensified bioprocessing such as WuXiUP™ (continuous bioprocessing platform) and WuXiUI™ (ultra-intensified fed-batch bioprocessing platform) to significantly enhance productivity; and the application of WuXia™ TrueSite, a next‑generation targeted integration (TI)-based CHO cell line platform. WuXia™ TrueSite achieves average mAb titers exceeding 8.0 g/L with outstanding expression stability across 60 generations.

Building on its innovative technology platforms, WuXi Biologics consistently leads the industry in manufacturing and bioprocessing excellence. The company has achieved a 100% success rate in PPQ campaigns. It has delivered more than 350 large‑scale batches (6,000 L – 16,000 L per batch) for global partners since 2017. The strong manufacturing track record is underpinned by WuXi Biologics' rigorous, global quality system. As of the end of 2025, the company had successfully passed 46 regulatory inspections, including 22 inspections conducted by the FDA and EMA. The company also holds an industry-leading record with a 100% pass rate for FDA Pre-License Inspection (PLI). Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network, with 136 facility license approvals and a 100% success in GMP inspections. Its world-class quality and compliance capabilities remain the cornerstone of global clients' trust.

WuXi Biologics is also pioneering digital innovation to transform biologics research, development and manufacturing. It has integrated digital innovation across end-to-end R&D, manufacturing, operations, and customer engagement, driving faster timelines, superior quality, and full partnership transparency. By leveraging digital manufacturing solutions, such as Electronic Batch Record (EBR), the company has driven an approximately 40% productivity gain, consistent data integrity and high product quality, while its advanced planning systems have delivered about a 20% improvement in efficiency. Recently, WuXi Biologics launched the industry-leading digital twin platform PatroLab^™ to enhance process performance, minimize process risks, shorten development timelines, and ensure consistent, high-quality biologics manufacturing.

The CDMO Leadership Awards and ceremony are produced by Life Science Connect and hosted by Outsourced Pharma. The awards have partnered with the Tufts Center for the Study of Drug Development (Tufts CSDD) to independently design, field, and analyze the research underlying the 2026 awards program.

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 13,000 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, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing.

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 

Media 
PR@wuxibiologics.com

Business
info@wuxibiologics.com

Pioneering the Intelligent Lab and Factory

One key driver of this year's record growth is the company's rapid transformation into a digitally-native powerhouse. By integrating advanced computational modeling, predictive analytics, and ontology-driven software development, WuXi Biologics has redefined the industry standard for speed, quality, and precision.

These proprietary intelligent systems have streamlined the entire biologics lifecycle, resulting in:

• Minimized Complexity: Eliminating manual bottlenecks through integrated, smart-automation workflows.
• Accelerated Timelines: Utilizing high-speed project-specific data synthesis and interpretation to shorten development cycles and bring life-saving therapies to patients faster.
• Enhanced Transparency: Providing clients with data-driven "line of sight" from initial molecule discovery through CMC and into commercial manufacturing.

Dr. Chris Chen, CEO of WuXi Biologics commented: "We are redefining the CRDMO role and value as a strategic partner powered by computational insights and agile execution—critical in today's dynamic biopharma innovation landscape. At the heart of this transformation is our unwavering commitment to accelerating our clients' scientific breakthroughs into clinical and commercial success through a fully integrated, end‑to‑end digital platform and predictive modeling, ultimately bringing meaningful benefits to patients worldwide."

Redefining Collaboration: The Next-Generation Client Digital Ecosystem

Complementing its operational advances, WuXi Biologics has launched a secure cloud-based client portal that redefines the collaborative experience. Moving beyond fragmented communication, the portal offers a unified, digitally-integrated workspace.

By providing access to up-to-date milestones, predictive data insights, and comprehensive program planning with fine-grained access controls, the platform ensures that critical information—including manufacturing, quality, and inventory metrics—is available in realistic time. This frictionless access to data eliminates the traditional "push" of manual updates, empowering clients to make faster, more informed decisions. By aligning all stakeholders on a single, synchronized source of truth, the portal strengthens strategic partnerships and accelerates the journey from DNA to IND to BLA without the delays of conventional reporting cycles.

As a global leading digital CRDMO, WuXi Biologics is embedding digital capability and infrastructure across the full biopharmaceutical value chain—turning data, computation, and prediction into faster development, intelligent operations, and more efficient manufacturing. With transparent client portal at the core, the company will continue to redefine the value of CRDMO partnership and help advance a more efficient, predictive, and scalable future for biopharmaceutical innovation—bringing its vision that "every biologic can be made" closer to reality for patients worldwide.

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 13,000 skilled employees in China, the United States, Ireland, Germany, Singapore and Qatar, 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, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 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

Business: info@wuxibiologics.com
Media: PR@wuxibiologics.com

HONG KONG, March 24, 2026 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions for biologics discovery, development and manufacturing, today announced audited results for the year ended December 31, 2025 ("Reporting Period").

Financial Highlights

Revenue: Revenue increased 16.7% YoY to RMB21.8 billion, driven by continued execution of the Group's "Follow and Win the Molecule" strategy, rising demands for complex biologics modalities including bispecific antibodies and ADCs, growing Research Services partnerships, and higher utilization of existing and newly expanded manufacturing capacity, including the ramp-up of the Group's European facility.  

Gross Profit and Gross Profit Margin: IFRS gross profit increased 30.9% YoY to RMB10.0 billion, with gross margin expanding 500 bps to 46.0%. Adjusted gross profit rose 25.5% YoY to RMB10.6 billion, with adjusted gross margin of 48.8%. Margin expansion was primarily driven by favorable business mix, higher capacity utilization, and efficiency gains from WBS and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 38.1% YoY to RMB9.0 billion, while adjusted EBITDA increased 22.8% YoY to RMB9.8 billion. EBITDA margin reached 41.5%, with adjusted EBITDA margin expanding to 45.1%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 45.3% YoY to RMB5.7 billion, while net profit attributable to owners of the Company grew 46.3% to RMB4.9 billion. These increases were primarily driven by the higher gross profits and the gains from the Group's investment portfolio.

Adjusted Net Profit and Adjusted Net Profit Attributable to Owners of the Company: Adjusted net profit increased 22.0% YoY to RMB6.6 billion, while adjusted net profit attributable to owners of the Company rose 17.9% YoY to RMB5.6 billion.

Earnings Per Share (EPS): Basic EPS rose 48.8% to RMB1.22 (2024: RMB0.82). Diluted EPS advanced 48.7% to RMB1.16 (2024: RMB0.78)

Adjusted Earnings Per Share (Adjusted EPS): Adjusted basic EPS increased 19.7% to RMB1.40 (2024: RMB1.17), while adjusted diluted EPS reached RMB1.33, up 18.8% from RMB1.12 in the prior year.

Business Highlights

• Integrated Project Adds

The Group added a record-high of 209 new integrated projects in 2025, bringing the total pipeline to 945 programs. Approximately half of the new additions originated from U.S. clients, reflecting strong momentum from the U.S. biopharma sector. With 74 late-stage and 25 commercial projects, the Group is well positioned to drive sustained manufacturing revenue growth.

Of the 209 new additions, 23 programs were post-IND wins under the Group's "Win-the-Molecule" strategy, including 6 late-stage programs, bringing total "Win-the-Molecule" projects to 112 since 2018.

• Research

Research Services delivered another phenomenal year in 2025, generating record-high upfront and total payments, and securing potential milestone and royalties over US$4 billion.

CD3 T-cell engager (TCE) partnerships continued to expand during the year, reflecting growing industry adoption of the Group's leading CD3 platform. The platform has been adopted by many leading biopharma companies, including Vertex, Merck, GSK and Sino Biopharmaceutical.

As of year-end 2025, Research Services supported 50+ active programs eligible for milestone payments and sales royalties, providing a growing base of high-margin long-term revenue potential.

• Development

The Group supported 156 IND filings in 2025, and expanded capacity to 200 INDs and 20 BLAs/MAAs annually. It also added a record number of new development projects in 2025. Bispecifics and ADCs accounted for 2/3 of new additions, with each modality growing by approximately 30% to 196 and 252 programs, respectively. Complex modalities now represent more than half of the entire project portfolio, reflecting sustained momentum in next-gen biologics and the Group's leading market position.

Leveraging its integrated R-D-M capabilities, bi- & multi-specifics have emerged as the Group's fastest growing modality, contributing nearly 20% of total revenue in 2025 and delivering 120%+ YoY growth. To support continued pipeline growth, the Group has expanded regulatory submission capacity to support approximately 200 INDs and 20 BLAs/MAAs annually.

During the Reporting Period, the Group introduced WuXia™ TrueSite, a targeted-integration CHO cell line platform that enables 6-month DNA-to-IND timelines, while delivering 8+ g/L mAb titers and >99% expression stability across 60 generations. The Group also expanded its high-dose drug delivery capabilities for clinical and commercial applications, including WuXiHigh^TM high-throughput formulation development, hyaluronidase co-formulation, and large-volume device solutions, further broadening their addressable commercial opportunities.

• Manufacturing

In 2025, the Group supported 74 Phase III projects and 25 commercial manufacturing projects, completed 28 PPQs (process performance qualification), and has 34 PPQs scheduled for 2026 based on contracts as of Dec 31, 2025. The Group maintained a 100% PPQ campaign success rate, demonstrating consistent execution and a robust large-scale manufacturing quality system.

To support the expanding commercial pipeline and enhance global supply resilience, the Group continues to advance its "Global Dual Sourcing" strategy, scaling integrated CRDMO capabilities across geographies, while expanding its manufacturing footprint globally.

• • U.S.: Construction of MFG11 in Worcester, MA is progressing. Upon completion, the facility will feature six 6,000L single-use bioreactors, a dedicated downstream line, and extensive automation. MFG18 in Cranbury, NJ is also being upgraded to add commercial manufacturing capabilities in response to the strong local demands.  
  • Singapore: Construction of a new modular drug product (DP) facility has commenced and is expected to be one of the largest modular biologics DP facilities globally, significantly enhancing the Group's end-to-end DP service capabilities. The design of a modular drug substance (DS) facility is also underway. In addition, WuXi XDC's Singapore site achieved mechanical completion in June 2025.
  • Qatar: In December 2025, the Group signed a MOU with the Qatar Free Zones Authority (QFZ), advancing plans to establish the Qatar site as a strategic hub within its global CRDMO network and extend its geographic presence into the Middle East.

• Backlog

As of December 31, 2025, total backlog stood at US$23.7 billion, including US$11.5 billion service backlog and US$12.2 billion potential milestones. Backlog within 3 years reached US$4.5 billion, providing strong visibility into near-term revenue growth.

• Quality

The Group maintains a comprehensive global quality management system to support clients' regulatory and compliance requirements. From 2017 to 2025, the Group has completed 46 regulatory inspections by major national authorities, including 22 by the U.S. FDA and EU EMA, with no critical issues and zero data integrity findings.

As of December 31, 2025, the Group maintains a 100% pass rate for FDA Pre-License Inspection (PLI) and has passed more than 1,800 client GMP audits, including 230+ conducted by EU Qualified Persons, demonstrating consistent quality and compliance standards across global operations.

• Talents

As of December 31, 2025, the Group employed 13,252 staff globally, including 4,885 scientists. The Group maintained a key talent retention rate of 96.4%, supporting continued execution across its global operations.

• WBS (WuXi Biologics Business System) and Digitalization

WBS remains a key driver of operational efficiency and margin expansion. During the Reporting Period, the Group completed 430+ Kaizen initiatives, contributing ~150 bps of gross margin improvement through enhanced labor productivity, cost control, and process optimization.

The Group also continued advancing its digital capabilities to support scalable operations for global partners. Our one-stop client portal enables secured real-time data access and collaboration, while core lab management system, together with in-silico modeling, and intelligent manufacturing systems such as Electronic Batch Records (EBR), Manufacturing Execution System (MES) enhance productivity, efficiency and quality. In addition, PatroLab™, the Group's digital twin platform, supports process optimization and risk mitigation in biologics development and manufacturing.

• Sustainability

Sustainability remains an integral part of the Group's long-term strategy and operations. During the Reporting Period, the Group continued to strengthen its ESG practices and received recognition from leading global ESG rating agencies.

The Group was included in the Dow Jones Sustainability Indices, achieved MSCI AAA ESG Ratings with inclusion in the MSCI ESG Indexes, and received the EcoVadis Platinum Medal. It also received a "Negligible-Risk" ESG rating from Sustainalytics and was recognized as both an Industry and Regional ESG Top-Rated Company. In addition, the Group was named to CDP's 2025 "A" lists for both Climate Change and Water Security.

Management Comment

Dr. Chris Chen, CEO of WuXi Biologics, stated, "In 2025, WuXi Biologics delivered record and profitable growth. Revenue increased 16.7% YoY, with revenue from continuous operations growing over 20%, while gross margin expanded 500 bps to 46.0%, supported by continued momentum across R-D-M, increased capacity utilization and operational efficiencies driven by WBS and digitalization.

Our unique CRDMO model, underpinned by full lifecycle R-D-M integration, represents a structural competitive advantage that enhances project retention and supports sustainable high growth. We are seeing accelerating momentum in complex biologics modalities, with bi- & multi-specifics and ADCs emerging as key growth drivers alongside our foundational mAb business.

Supported by continued CD3 TCE deal momentum, Research Services delivered another record year in upfront and total payments. Development supported 156 IND filings and expanded capacity to 200 INDs and 20 BLAs/MAAs annually. We also added a record 209 new integrated projects, with 2/3 involving bispecifics and ADCs, reflecting strong demand for complex biologics and our leading market position. Manufacturing revenue grew 26.4% YoY, supported by 28 PPQs in 2025, the progressions of phase II and III projects as well as the ramping of the existing projects. Notably, 34 PPQs have been scheduled for 2026, providing good visibility into future manufacturing revenue growth.

Looking ahead, we will continue to expand our global CRDMO network by strengthening integrated capabilities globally. With our differentiated CRDMO platform, ongoing investments in advanced technologies and digitalization, and growing pipeline, we are well positioned to support our global partners and drive the next phase of growth."

Dr. Ge Li, Chairman of WuXi Biologics, added, "In 2025, WuXi Biologics accelerated its business growth across Research, Development, and Manufacturing. Looking ahead, we remain committed to creating long-term value for our partners and strengthening our role as a trusted partner to the global biopharmaceutical industry as we advance our vision that 'every biologic can be made'."

Key Financial Ratios
(For the Twelve Months Ended Dec 31)

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 13,000 skilled employees in China, the United States, Ireland, Germany, Singapore and Qatar, 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, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 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

Investor: IR@wuxibiologics.com
Media: PR@wuxibiologics.com

WuXi Biologics has been named to the CDP Water Security "A List" for three consecutive years, underscoring an industry-leading performance in environmental stewardship and transparency. This achievement reflects the company's long-standing dedication to sustainable water management, including its diligent efforts to meet water targets, fulfill clients' sustainability expectations, and continually enhance water management practices.

Significant Progress in Systematic Water Management 

WuXi Biologics actively supports the United Nations Sustainable Development Goal regarding clean water and sanitation (SDG 6), and has established a comprehensive water management framework with clear targets and ongoing progress tracking. With 2019 as the base year, the company aimed to reduce water consumption intensity by 30% by 2025, and, at the conclusion of 2025, had fully achieved this ambitious goal, demonstrating the company's unflagging commitment to excellence in water stewardship, and the success of its endeavors to improve water efficiency and minimize its environmental footprint.

Roll Out of WES Across Global Operations

To promote and support site-specific water stewardship and management across the company, WuXi Biologics launched a Water Excellence Stewardship (WES) program in 2024 covering such material topics as water governance, water balance, water quality, and safe water/environmental and personal hygiene (WASH). Through WES, each site can assess its own sustainable water management performance, identify improvement opportunities, and ensure alignment with international best practices. By the end of 2025, the WES program had been rolled out at 10 of the company's global sites.

Dr. Chris Chen, WuXi Biologics CEO and Chairman of the ESG Committee, commented, "Natural resources are fundamental to the human well-being, and are indispensable in the the research, development and production of biologics. WuXi Biologics is committed to protecting the environment and pursuing sustainability by operating responsibly, while advancing exemplary water stewardship, and promoting universal access to water and sanitation. As a global leader in Green CRDMO, we consistently deliver ESG excellence, enable partners worldwide to fulfill ESG commitments, and jointly work with all stakeholders to promote responsible practices throughout the entire value chain."

As a participant of the United Nations Global Compact (UNGC) and the Pharmaceutical Supply Chain Initiative (PSCI), WuXi Biologics proactively advocates sustainability and has earned widespread recognitions for its efforts. In addition to being named to the CDP "A List" for Water Security, the company was named to the CDP "A List" for Climate Change and rated "A" in the CDP Supplier Engagement Assessment; granted an MSCI AAA Rating; awarded an EcoVadis Platinum Medal; listed in the Dow Jones Best-in-Class Indices; given the highest negligible-risk rating by Sustainalytics, and recognized as a Sustainalytics industry and regional ESG top-rated company for five consecutive years; selected as a Constituent of the FTSE4Good Index Series; listed in the Hang Seng Corporate Sustainability Benchmark Index; and rated as Prime by ISS ESG Corporate Rating.

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, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing.

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

ESG
esg@wuxibiologics.com

Media
PR@wuxibiologics.com

WuXi Biologics was named the winner in the following categories:

• Best Contract Development & Manufacturing Organization Award
• Best Aseptic Fill-Finish & Packaging CMO of the Year
• Bioprocessing Excellence in Asia
• Bioprocessing Excellence in China
• Bioprocessing Facility of the Year
• Excellence in Bioprocessing Automation & Digitalization

In addition to corporate honors, Dr. Sherry Gu, Chief Technology Officer, Executive Vice President, was named CTO of the Year, in recognition of her outstanding vision, technological innovation, and leadership in advancing biologics development and bioprocessing excellence, and Dr. Jeremy Guo, Head of Global Drug Product Operations, Senior Vice President, received the award of Head of Fill-Finish & Formulation of the Year, honoring his remarkable expertise and dedication in driving high-quality, compliant, and reliable drug product manufacturing and aseptic processing capabilities.

Dr. Chris Chen, Chief Executive Officer of WuXi Biologics, stated, "We are honored to receive this unprecedented number of awards at the 2026 Asia-Pacific Biopharma Excellence Awards. These accolades reflect the trust of our global partners, the expertise of our team, and our unwavering commitment to quality, innovation, and operational excellence. As we continue to scale our integrated CRDMO platform, advance digital and intelligent bioprocessing and manufacturing, we remain committed to accelerating our partners' innovative therapies to patients worldwide."

This year's awards further validate WuXi Biologics' leading position as the partner of choice for biopharma innovators and multinational corporations worldwide. The company has 945 integrated projects on its platform, making it one of the world's largest portfolios of complex biologics. Among them, nearly 50% are bi- and multi-specific antibodies and ADCs. It continues to expand its integrated services through new technology solutions that accelerate timelines, improve product quality and ensure scalable manufacturing. In 2025, the company launched WuXia™ TrueSite, its industry-leading targeted integration-based CHO cell line platform, achieving average mAb titers over 8.0 g/L and outstanding expression stability through 60 generations. It has also advanced its high-dose delivery technologies into clinical and commercial use, including its high-throughput formulation development platform WuXiHigh™, which enables protein concentrations of up to 230mg/mL and achieves viscosity reduction by up to 90%.

Building on its innovative technology platforms, WuXi Biologics consistently leads the industry in manufacturing and bioprocessing excellence. The company has achieved a 100% success rate in PPQ campaigns. It has delivered more than 350 large‑scale batches (6,000 L – 16,000 L per batch) for global partners since 2017. The strong manufacturing track record is underpinned by WuXi Biologics' rigorous, global quality system. As of the end of 2025, the company had successfully passed 46 regulatory inspections, including 22 inspections conducted by the FDA and EMA. The company also holds an industry-leading record with a 100% pass rate for FDA Pre-License Inspection (PLI). Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network, with 136 facility license approvals and a 100% success in GMP inspections. Its world-class quality and compliance capabilities remain the cornerstone of clients' trust.

WuXi Biologics is also pioneering digital innovation to transform biologics research, development and manufacturing. It has integrated digital innovation across end-to-end R&D, manufacturing, operations, and customer engagement, driving faster timelines, superior quality, and full partnership transparency. By leveraging digital manufacturing solutions, such as Electronic Batch Record (EBR), the company has driven an approximately 40% productivity gain and consistent data integrity and high product quality, while its advanced planning systems have delivered about a 20% improvement in efficiency. Recently, WuXi Biologics launched the industry-leading digital twin platform PatroLab^TM to enhance process performance, minimize process risks, shorten development timelines, and ensure consistent, high-quality biologics manufacturing.

Presented by IMAPAC, the Asia-Pacific Biopharma Excellence Awards honor outstanding innovation, operational rigor, and industry leadership across bioprocessing, supply chain, ADC development, and clinical development. Recognizing the remarkable contributions of leading biopharma professionals, organizations, and technologies, the awards spotlight trailblazing leaders and trendsetters shaping the industry's future while inspiring innovation for tomorrow's biopharma landscape.

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, Singapore and Qatar, 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, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing.

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

Media
PR@wuxibiologics.com

Business
info@wuxibiologics.com