Press Releases

WuXi XDC’s DP4 Facility in Singapore Achieves GMP Release, Marking Another Major Leap in Global Manufacturing Capacity

(Singapore, August 28, 2026) – WuXi XDC Cayman Inc. (“WuXi XDC”, stock code: 2268.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, announced that its first drug product (DP) manufacturing facility DP4 for bioconjugates at Singapore site has successfully achieved GMP release. This milestone represents not only a further expansion of manufacturing capacity, but also a substantive upgrade of the WuXi XDC’s global supply network, laying a more solid foundation for continuously empowering clients and accelerating the delivery of innovative therapies to patients worldwide.

The DP4 facility is equipped with one 10 m² and two 30 m² lyophilizers, providing an annual production capacity of up to 8 million vials of liquid or lyophilized bioconjugates. The facility strictly adheres to GMP standards set by the FDA, EMA and HSA, ensuring full-process compliance and product quality control throughout the entire manufacturing workflow.

The facility offers comprehensive end-to-end sterile drug product manufacturing and packaging services, covering tools washing and sterilization, compounding, vial washing, depyrogenation, filling, lyophilization, capping, external washing, manual visual inspection, automated visual inspection, labeling, and packaging. The core filling line is equipped with a state‑of‑the‑art sterile isolator, enabling 100% in‑line filling weight checking and utilizing vacuum‑free stoppering technology. The filling speed can reach up to 300 vials per minute, with a camera‑based vision system that performs real‑time rejection of vials with missing or high‑seated stoppers. The lyophilizers employ liquid nitrogen cooling technology and are fitted with fully automated loading and unloading systems. The automated visual inspection machine incorporates a multi‑color imaging processing system, headspace oxygen detection, and pulsed X‑ray technology. In addition, the line is equipped with a semi‑automated PUPSIT (Pre‑use Post Sterilization Integrity Test) filtration system, AGV (Automated Guided Vehicle) automated transfer, and fully automated material disinfection devices. The automated packaging line integrates single‑vial and multiple‑vial formats, accommodating both commercial and clinical production needs, and features labeling, cartoning, secondary packaging, and drug traceability functions to enable efficient, precise, and orderly production.

The DP4 facility is built to the highest international standards and incorporating state‑of‑the‑art technologies, it features a unique modular facility design with unidirectional flow, advanced high‑potency sterile equipment, strict risk classification management, innovative single‑use technologies with a comprehensive environmental monitoring system, and fully automated material transfer and disinfection systems. The facility supports both liquid and lyophilized sterile bioconjugates, delivering integrated one‑stop solutions from clinical to commercial manufacturing. As WuXi XDC’s first overseas drug product facility, DP4 adheres to the consistently high efficiency and quality, having rapidly completed the entire process from facility construction, commissioning and qualification (C&Q), aseptic processing simulation, to GMP release in just 29 months.

Dr. Jimmy Li, CEO of WuXi XDC, commented, “The on‑schedule GMP release of the DP4 facility marks the second production capacity addition at our Singapore site, following the GMP release of the BCM3 facility in the middle of August. This achievement completes our manufacturing capabilities in Singapore, enabling us to offer end‑to‑end services across antibodies, bioconjugate drug substances, and drug products. As the first overseas site in WuXi XDC’s global network, we are fully confident in its sustained growth and future contributions. Looking ahead, WuXi XDC will remain committed to insight‑driven services, delivering on our promises with speed, and accelerating the discovery, development, and manufacturing of bioconjugates worldwide through our integrated CRDMO platform—empowering our global partners with more resilient supply networks and globally quality standards and collectively shaping a more accessible future for health.”

About WuXi XDC

WuXi XDC Cayman Inc. (stock code: 2268.HK) is a globally recognized contract research, development, and manufacturing organization (CRDMO) specializing in bioconjugates. The company offers a wide range of innovative conjugation and payload-linker technologies to facilitate the development of next-generation antibody-drug conjugates (ADCs). Focused on early-stage research and development of ADCs and other bioconjugates, WuXi XDC offers comprehensive one-stop services from clinical to commercial manufacturing. 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