The Company’s API site at Changzhou underwent a GMP surveillance inspection by the FDA that began on March 4. Covering 21 FDA-approved products, the inspection followed the FDA’s six-system inspection model. The FDA inspectors concluded the review one day ahead of schedule. No observation was raised.

On March 21, 2025, the API site at Taixing also completed a Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic, with no observation. The site presented its state-of-the-art infrastructure, the team’s strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records. Operational since September 2023, the 169-acre Taixing site is the company’s newest and largest API manufacturing facility. The successful inspection confirms the site’s readiness to support commercial API supply to the global market.

“Our team’s consistent focus on quality and compliance is key to enabling our global partners,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “We’re pleased that both the Changzhou and Taixing sites passed their FDA inspections with no observation. These successful results further reinforce WuXi AppTec’s dedication to providing high-quality R&D and manufacturing solutions that support our customers worldwide in accelerating new drug development and commercialization for the benefit of patients.”

The Changzhou and Taixing sites are critical manufacturing bases of WuXi STA, the company’s small molecule CDMO platform, and WuXi TIDES, which provides integrated CRDMO services for oligonucleotides, peptides, and synthetic conjugates. Both sites support the manufacturing of APIs and intermediates across a wide range of chemical modalities.

WuXi AppTec continues to invest in capacity expansion to meet growing global demand. The company’s investment in its Couvet, Switzerland, site resulted in doubling oral dose capacity over the course of 2024. Meanwhile, WuXi AppTec continued to build its U.S. (Middletown, DE) site, which is expected to commence operations by the end of 2026. In May 2024, the company announced the groundbreaking of Singapore R&D and manufacturing site; Phase I expects to commence operations in 2027.

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.” Please visit: http://www.wuxiapptec.com

EcoVadis provides benchmarks for rated companies in their industry to drive global supply chain sustainability and encourage industry-wide competence to achieve better global practice and continuous improvement. The ratings assess corporate performance across four core areas: Environment, Labor & Human Rights, Ethics, and Sustainable Procurement. With an impressive score, WuXi AppTec’s Couvet site ranks in the top 9% of all rated companies, showcasing its commitment to sustainable business practices.

As a state-of-the-art pharmaceutical manufacturing facility, the Couvet site plays a vital role in WuXi AppTec’s CRDMO business model by providing both clinical and commercial scale manufacturing capabilities for oral solid dosage forms. The facility was designed with industry-leading energy efficiency and environmental standards and was built to accommodate future sustainable growth.

In addition to receiving the EcoVadis silver medal, the site was also recertified for ISO 14001 & ISO 45001 accreditations to the advanced environmental, health and safety management systems that enhance its sustainability performance.

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development, and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024, and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

New facility enhances the Company’s drug substance process R&D capacity to drive innovation across all synthetic modalities and meet growing global demand.

WuXi AppTec announces the recent opening of its new R&D center in Changzhou, China, significantly expanding its capabilities in developing advanced therapies covering small molecules, oligonucleotides, and peptides as well as complex synthetic conjugates. This 33-acre center of excellence offers a flexible design, strengthening the Company’s drug substance process research and development service offerings with increased capacity and accelerated timelines, while reducing costs and environmental impact.

Strategically located just 15 minutes from our existing Changzhou API manufacturing site, the new R&D Center is a critical R&D hub for both WuXi STA, the Company’s small molecule CRDMO platform, and WuXi TIDES, which delivers oligonucleotide and peptide CRDMO services. The proximity facilitates seamless collaboration between R&D and manufacturing; the Center’s state-of-the-art capabilities integrate process R&D and analytical services to support projects from preclinical through commercialization.

Designed with six R&D buildings, upon full operation, the Center will accommodate approximately 3,000+ scientists with 170+ specialized laboratories.

The first operational building, dedicated to API development for oligonucleotides, peptides, and complex synthetic conjugates, spans over 160,000 square feet. Its innovative design specifically supports development for “TIDES” Drugs with features such as specialized solvent pipelines, reclaimed process water systems, and infrared-activated fume hoods to enhance efficiency, sustainability, and safety. Currently, the first operational building houses 500 scientists. It offers a comprehensive suite of services with most advanced process and analytical technologies all designed to meet the complex demands of oligonucleotide and peptide drug development. The modular lab integrates essential workflows with latest digitalization and automation controls to achieve faster data turnaround and higher efficiency.

“This new facility reinforces our ongoing commitment to supporting customers as they advance global health,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “By strengthening our end-to-end CRDMO capabilities for all synthetic modalities, we further empower our partners with comprehensive solutions from discovery through commercialization, and a faster, more streamlined pathway to market. Together, we’re dedicated to accelerating more innovative therapies to patients worldwide.”

Rendering of the 33-Acre R&D Center Campus in Changzhou, China

SINGAPORE, May 23, 2024 – WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, today announced the groundbreaking of its new R&D and manufacturing site in Singapore. This milestone, following the announcement of the new site in 2022, marks another step forward in WuXi AppTec’s mission to continuously enhance its CRDMO enabling platform to better support customers worldwide in advancing healthcare treatments and innovations.

The new 50-acre Singapore site is located in the thriving Tuas Biomedical Park with the master planning and development by JTC to encompass a total of seven plants at its full capacity, providing active pharmaceutical ingredient (API) R&D and manufacturing services for small molecules, oligonucleotides, peptides, and complex synthetic conjugates. Embracing industry-leading green chemistry technology initiatives, this new site is dedicated to improving industrial practices and promoting sustainable development of the local community. As a key part of the company’s global network, the Singapore site will integrate closely with WuXi AppTec’s existing sites across Asia, Europe, and North America, offering effective CRDMO solutions for new drug R&D from discovery to commercialization with expanded flexibility and scalability.

Mr. Png Cheong Boon, Chairman of the Singapore Economic Development Board (EDB), said, “WuXi AppTec’s comprehensive CRDMO facility marks the company’s first foray into Singapore, and is a timely addition to Singapore’s thriving and growing pharmaceutical and biotechnology sector. With R&D and manufacturing activities housed under one roof, WuXi AppTec will be building a sizeable local team to drive the development of innovative therapeutics in Singapore to serve patients globally. Singapore remains committed to working with global healthcare partners to bring novel healthcare solutions to the rest of the world.”

“We are thrilled to break ground on our long-planned site in Singapore. The progress we’ve made with many of our local partners is remarkable,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “As we continue to enhance our capabilities and capacities to deliver high-quality solutions that meet the evolving needs of our customers, the new Singapore site will help us better serve our customers both locally and around the world.”

“At WuXi AppTec, our vision is that one day every drug can be made and every disease can be treated,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “We are proud to work with like-minded partners in Singapore to carry out this vision for the global pharmaceutical and life sciences industry. With the enhanced capacity and capabilities we are building at this new Singapore site, we look forward to continuing to help our customers accelerate the development and commercialization of life-saving treatments and medicines for patients around the world.”

The new Singapore site is projected to start operation in 2027 and will be built in different phases. The site is expected to bring approximately 1,600 employment opportunities once fully built.

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the third consecutive year in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

Media Contact:

Davy Wu

mediainquiries@wuxiapptec.com

Since January 2024, we’ve tripled our solid-phase peptide synthesis capacity to more than 32,000 L across our Changzhou and Taixing sites, and more capacities will be added in Taixing and Singapore to accelerate peptide drugs to patients.

Shanghai, China – January 8, 2024 — WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries to advance discoveries and deliver groundbreaking treatments to patients, announced the commissioning of its two new peptide manufacturing plants, one at its Changzhou facility and another at the new Taixing site in China. This significant expansion has increased the company’s Solid-Phase Peptide Synthesis (SPPS) total reactor volume to 32,000 liters, addressing the surging global demand for peptide therapeutics.

With this announcement, the Changzhou site inaugurated its third peptide plant. The other newly commissioned peptide plant is situated at the company’s Taixing site. Both new peptide plants utilize cutting-edge digital operation systems with automated solvent delivery, optimizing production consistency, minimizing human errors, and reducing production cycle time.

The company’s WuXi TIDES CRDMO platform provides integrated services for oligonucleotides, peptides, and conjugates, including both API and drug product from discovery to commercial stages. In 2023 alone, WuXi TIDES supported about 50 preclinical to commercial stage peptide projects and produced more than 15 metric tons of peptide APIs and intermediates. With the newly expanded capacity, WuXi TIDES is poised to support more peptide therapeutic developments for global partners.

Commissioning the peptide plant at the Taixing site marks its official launch as the newest and largest of WuXi AppTec’s five API production sites.  Spanning a total area of 169 acres, the Taixing site is designed to manufacture a range of synthetic molecules, including small molecules, peptides, oligonucleotides, and conjugates. The phase I construction includes nine plants with the total reactor volume exceeding 1,000 m³, including a dedicated plant for API clean rooms. This setup enhances API manufacturing efficiency for global customers. Once Taixing site Phase I is fully operational in 2025, the company’s total reactor volume for small molecule API and intermediate manufacturing will surpass 4,000 m³.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec, commented: “The launch of our new peptide manufacturing plants and the development of the new Taixing site are important milestones for WuXi AppTec. Our expanded capacity is essential for accelerating drug development and ensuring a reliable supply chain for our global partners. WuXi AppTec will continue to focus on enhancing our capability and capacity, accelerating innovative therapies to patients globally.”

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”

Meeting Occupational Exposure Limits (OEL) as low as 10 ng/m3, the new HP injectable manufacturing line utilizes fully enclosed isolation systems and automated filling machines. This design effectively minimizes human intervention, preventing cross-contamination and ensuring stringent quality assurance for sterile products. The line is equipped with two 20 m2 lyophilizers and supports liquid and lyophilized vials of various specifications, with a filling rate of up to 200 units per minute. Adhering to the International Society for Pharmaceutical Engineering (ISPE) guidelines, regular industrial hygiene monitoring is conducted to maintain the rigorous integrity of the sealed isolators. This commitment to stringent compliance, along with the integration of an independent air conditioning system and a bag-in bag-out (BIBO) exhaust air purification system, guarantees the safety of operators, the environment, and the product quality.

The Wuxi City drug product site currently has two fully automated sterile injectable manufacturing lines, with manufacturing capacity of 2 million and 10 million units annually, respectively. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges. In addition, the company’s sterile lipid nanoparticle (LNP) platform has also started operation at the Wuxi City site, with a batch production capacity ranging from 10 to 50 liters, supporting the formulation development of complex new modalities, especially oligonucleotide-based drug candidates. By 2024, WuXi STA plans to add two more injectable manufacturing lines at the same site, with additional lines also set to be added to the Couvet site in Neuchâtel, Switzerland and upcoming Middletown site in Delaware, USA.

The ongoing enhancement of the injectable platform will also effectively synergize with the WuXi TIDES CRDMO platform, providing integrated CMC solutions for both API and drug products for the development of oligonucleotides, peptides, and related complex chemical conjugates. To date, WuXi TIDES has gained experience from over 30 integrated CMC projects related to oligonucleotide and peptide drugs. The completed projects have demonstrated notable speed and efficiency advantages, typically progressing from API process development to being IND-ready within a 9-10 month timeframe.

In addition, WuXi STA has established comprehensive capabilities in R&D and production of HPAPI with many years of experience. With the launch of the new HP injectable line, combined with the HP oral drug production line, the company further enhanced its HP CMC platform that now provides an end-to-end solution including both API and drug product, seamlessly covering the entire life cycle of HP new drug development from research all the way to commercial manufacturing.

“I’m thrilled that our HP injectable R&D and manufacturing platform has achieved yet another significant milestone,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA. “In addressing the growing needs of high potency drugs, WuXi STA, as an innovation enabler, will continue to strengthen our CRDMO platform capabilities. With our proven track record of consistent quality and EHS systems across all sites globally, we are committed to accelerating pharmaceutical development and bringing new therapeutics for patients worldwide.”

About WuXi STA

WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.

For more information, please visit: https://sta.wuxiapptec.com/

ArkBio is a biopharmaceutical company dedicated to addressing unmet clinical needs in pediatric and respiratory diseases. Arkbio’s innovative drug, ziresovir, is a First-in-Class small molecule RSV fusion (F) protein inhibitor and is the first oral RSV antiviral drug successfully completed the phase III clinical trial globally. Currently, ziresovir’s New Drug Application (NDA) has been accepted and granted Priority Review by the China NMPA. Ziresovir is potentially the world’s first-approved anti-RSV therapeutic drug.

As a long-term partner of ArkBio, WuXi STA has provided customized formulation R&D and manufacturing services for ziresovir during its development process. In the first quarter of 2023, WuXi STA’s Waigaoqiao site successfully passed the NMPA’s Pre-Approval Inspection (PAI) for ziresovir, providing the strong support for its upcoming NDA approval in China. According to the agreement, both companies will continue to strengthen the collaboration in various aspects from customized formulation R&D to commercial manufacturing.

Dr. Jim Wu, Chairman and CEO of ArkBio, said: “ArkBio is about to become a biopharmaceutical company with both R&D and commercial capabilities. We are delighted to expand our cooperation with WuXi STA at this crucial stage. We believe that with WuXi STA’s strong platform capabilities and industry experience, through our close collaboration, ziresovir will have an efficient and robust supply chain after it goes to market, and will soon bring benefits to a broad population of RSV patients.”

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, stated: “We are excited to deepen our cooperation with ArkBio, which demonstrates the capability of our CRDMO platform. Through the successful collaboration between ArkBio and WuXi STA, we will continue to leverage our industry-leading platform with broad capability and extensive capacity, as well as the global standard quality system, empowering the commercialization process of ziresovir to benefit a greater number of patients globally.”

About ArkBio

ArkBio is a global biopharmaceutical company focusing on discovery and development of innovative drugs for unmet medical needs, especially in pediatric and respiratory disease areas. Since its inception in 2014, the company has established core technology platforms and has created innovative drugs with global patent protection. Through in-house R&D efforts and external collaborations, the company has developed a promising and highly differentiated product pipeline. The core product, ziresovir, is the world’s leading anti-RSV therapeutic drug that has received a breakthrough designation from China’s regulatory authority NMPA, and currently under NDA review by the China CDE. Its another near-commercial asset is an attention deficit hyperactivity disorder (ADHD) drug AZSTARYS® recently approved by the FDA. ArkBio owns the right for its development and commercialization in Greater China. The pipeline programs also include a battery of clinical and pre-clinical stage drug candidates with first- or best-in-class potential for global development.

ArkBio strives to become a leading global biopharmaceutical company with integrated technology platforms for drug discovery and development, manufacturing, and commercialization in pediatric and respiratory therapeutic areas.

For more information, please visit www.arkbiosciences.com

For investor relation please contact: IR@arkbiosciences.com

About WuXi STA

WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: https://sta.wuxiapptec.com/

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April 5, 2023 – WuXi STA, a global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has added two 2,000 L reactors and a large-scale continuous purification system for peptide manufacturing at the Changzhou campus. The new additions further enhance the capability and capacity of WuXi TIDES. As an integral part of WuXi STA, WuXi TIDES is an end-to-end CRDMO platform for oligonucleotide, peptide, and related synthetic conjugates (“TIDES” drugs), simplifying the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof.

With the two new 2,000 L reactors in operation, the total reactor volume of the Solid Phase Peptide Synthesizers (SPPS) at WuXi TIDES has increased to over 10,000 L.

Besides significant peptide capacity expansion, WuXi TIDES also added a new continuous purification system that features 300-DAC twin columns for continuous purification of kilogram-scale peptide and oligonucleotide. The continuous mode enables a purification process with a faster turnaround time and lower solvent consumption, allowing for a more efficient and sustainable peptide and oligonucleotide manufacturing.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, said, “We are pleased to support our global partners in their efforts to develop TIDES therapies for patients in need. We are committed to continuously enhancing our WuXi TIDES CRDMO platform’s capacity and capability to expedite the development and commercialization of more innovative therapies for patients worldwide.”

About WuXi STA

WuXi STA (stapharma.com), a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations across Asia, North America, and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. For more information, please visit: https://sta.wuxiapptec.com/