Press Releases

Wuxi, China, December 17, 2024 — WuXi XDC (stock code: 2268.HK), a global leader in providing end-to-end CRDMO services for antibody-drug conjugates (ADC) and other bioconjugates, recently announced that its state-of-the-art dual-function ADC production facility, XBCM2 Line2, has officially commenced operations. The facility‘s inaugural integrated process project, encompassing cell culture，antibody purification，and the production of conjugated bulk drug substances, has been successfully completed. This landmark achievement underscores WuXi XDC’s commitment to expanding capacity and driving technological innovation, solidifying its position at the forefront of integrated biopharmaceutical processes.

Industry-Leading Dual-Function Design

The XBCM2 Line2 facility exemplifies efficiency and flexibility, embodying the industry’s leading “dual-function production line” design concept. It delivers comprehensive production services, spanning from antibody intermediates to conjugated bulk drug substances, establishing a seamless, one-stop solution for commercial-scale production. The production line integrates advanced upstream cell culture and downstream protein purification capabilities with an annual production capacity of 60 batches at a 2,000L scale for antibody intermediates and 80 batches at a 1,000L scale for conjugated bulk drug substances.
 
Market insights from Frost & Sullivan indicate rapid growth in the global ADC market, with the global market size projected to reach $63.8 billion by 2030, and the Chinese market expected to reach RMB 68.9 billion in the same year. WuXi XDC’s efficient and high-quality capacity expansion is poised to address the global shortage of ADC production capacity, delivering superior biopharmaceutical solutions to clients and benefiting patients worldwide.

Unparalleled Speed: Construction and Operational Milestones

WuXi XDC has demonstrated exceptional execution and cutting-edge technology, completing the entire process from facility design to operational readiness with a record-breaking 10 months. Remarkably, the facility was operational for a complex, innovative integrated process project just one and a half months after its release, highlighting the unparalleled “WuXi Speed”.

During this accelerated timeline, WuXi XDC constructed high-standard clean areas and supporting utility facilities, including challenging high-toxicity production areas. Given the stringent requirements for the small molecule drugs in ADCs– known as the “biological missile” core due to their high toxicity –the facility’s design incorporates advanced safety measures, optimized production workflows, and robust emergency response systems. The multifunctional layout significantly minimizes material transfer and waiting times, markedly enhancing production efficiency.

Precision in Planning and Execution

WuXi XDC’s success in delivering the XBCM2 Line2 facility was underpinned by meticulous planning, rigorous execution, and an unwavering commitment to excellence. From the outset, the team conducted in-depth analysis of critical project milestones, proactively identifying and mitigating potential risks to ensure on-time and high-quality delivery. The integration of proprietary equipment innovations, such as DFB systems with built-in temperature control, played a crucial role in maintaining microbial control and supporting diverse production needs.
 
Moreover, WuXi XDC achieved an impeccable safety record, logging 330,000 construction hours without a single accident. This achievement underscores the company’s steadfast commitment to safety, operational excellence, and social responsibility. The precision execution ensured that every aspect – from facility design and construction to operational readiness – met the highest standards of quality and efficiency.

Pioneering a New Era of Integrated Processes

Within just one and a half months of XBCM2 Line2’s release, WuXi XDC successfully delivered its first batch of conjugated bulk drug substances for an innovative integrated process project. This achievement reflects the company’s leadership in biopharmaceutical innovation and exceptional execution.

To accomplish this milestone, WuXi XDC implemented advanced quality systems, conducted rigorous regulatory risk assessments, and adopted continuous production strategies. The team synchronized technical transfers and process optimizations to ensure seamless operations. The integrated process involved complex purification workflows, including multiple chromatography steps, which the production team navigated with precision, delivering high-quality results with zero deviations.

Dr. Jimmy Li, CEO of WuXi XDC, remarked: “The successful launch of XBCM2 Line2 and the delivery of its first production batch represent a significant milestone in our journey of growth and innovation. From design and equipment selection to project implementation and production execution, WuXi XDC teams have demonstrated unwavering commitment and professionalism. Despite tight deadlines and complex tasks, our team exceeded expectations, ensuring every detail was executed flawlessly. This achievement is a testament to the passion, expertise, and collaboration spirit. Looking ahead, we will continue advancing our technology platform, fostering innovation, and delivering high-quality solutions to our clients.”
 
About WuXi XDC

WuXi XDC Cayman Inc. (“WuXi XDC” or the “Company”, stock code: 2268.HK) is a leading global CRDMO focused on antibody drug conjugates (ADC) and the broader bioconjugate market. It provides end-to-end contract research, development and manufacturing services for bioconjugates, including ADCs. Its services cover antibody intermediates and other biologics intermediates, chemical payloads and linkers, as well as bioconjugate drug substances and drug products. For more information about WuXi XDC, please visit: www.wuxixdc.com.
 
WuXi XDC Contacts

Investor：wuxixdc.ir@wuxibiologics.com

Media：wuxixdc_pr@wuxibiologics.com

BD：wuxixdc_info@wuxibiologics.com