SINGAPORE, Sept. 21, 2026 /PRNewswire/ –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, today held a grand GMP release ceremony for its Singapore manufacturing site at Tuas Biomedical Park. From announcing the new site in March 2024 to achieving GMP release of the BCM3 antibody intermediate and conjugated drug substance dual-function production line and the DP4 facility in August 2026, this important milestone was reached in only two and a half years. It marks the transition of WuXi XDC’s "Global Dual-Sourcing" strategy from blueprint to reality, opening a new chapter in empowering more global clients to accelerate commercial manufacturing.
- Grand Ceremony Opens
At the beginning of the event, Dr. Jimmy Li, CEO of WuXi XDC, delivered opening remarks. He noted that the successful GMP release of the company’s first overseas manufacturing site is a key step in WuXi XDC’s global manufacturing footprint. Leveraging a globally leading quality system, cutting-edge innovation, and operational excellence, the company will continue to enhance the resilience and diversification of its supply system. The Singapore site will form a global collaborative network with sites in Wuxi, Shanghai, Hefei, and Suzhou, continuing to provide clients with end-to-end, one-stop CRDMO solutions for bioconjugates.
In her opening remarks at the event, Ms. Cindy Koh, Executive Vice President of the Singapore Economic Development Board (EDB) congratulated WuXi XDC for the GMP release of its Singapore site. She highlighted how the investment strengthens Singapore’s capabilities in manufacturing complex new modalities and reflects WuXi XDC’s confidence in Singapore as a trusted hub for biopharmaceutical manufacturing.
As a strategic partner of WuXi XDC, Mr. Li Daoquan, CEO of Morimatsu Pharmadule(China), was also invited to share his thoughts, recalling the efficient collaboration and outstanding execution between the two parties in the construction of the modular factory.
Following the speeches, the ribbon-cutting ceremony for the WuXi XDC Singapore site was held. Ms. Cindy Koh, Executive Vice President of EDB; Ms. Christine Wong, Assistant CEO (Cluster Group) of JTC Corporation; Dr. Jimmy Li, CEO of WuXi XDC; Mr. Jerry Zhang, COO of WuXi XDC; Dr. Marie Zhu, CTO of WuXi XDC; Dr. Hu Jun, Head of APAC Business Development & Global Commercial Operations and Singapore Site Management of WuXi XDC; and Dr. Zhang Xiao, Head of Conjugated Drug Substance and Singapore Site Production of WuXi XDC; Dr. JJ Luo, Head of Bioconjugate Drug Products Development of WuXi XDC, jointly took the stage, officially launching the GMP release of the WuXi XDC Singapore manufacturing site.
- Capacity Upgrade to Empower Commercial Manufacturing
The Singapore site serves as a core cornerstone of WuXi XDC’s commercial manufacturing, spanning approximately 25,000 square meters. The site’s BCM3 dual-function production line and DP4 conjugated drug product facility have both successfully achieved GMP release.
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- The BCM3 features an efficient and flexible "dual-function" design, offering integrated end-to-end commercial manufacturing services from antibody intermediates to conjugated drug substances. The production line supports batch sizes from 200 L to 2,000 L for antibody intermediates and up to 2,000 L for conjugated drug substances. The line strictly follows international GMP standards such as FDA, EMA, and NMPA, and has established a comprehensive quality control system. In addition, the BCM4 facility is expected to achieve GMP release by the end of 2026, with a maximum single-batch capacity of up to 500 L of conjugated drug substance.
- 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. The core filling line is equipped with a state‑of‑the‑art sterile isolator, enabling 100% in‑line filling weight checking. 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 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.
- Site Tour Highlights One-Stop Capabilities
After the ceremony, WuXi XDC invited guests to tour the Singapore site. The tour attracted active participation from dozens of MNCs and global biotech companies. The site demonstrated to the industry its integrated end-to-end production capabilities for antibody intermediates, conjugated drug substances, and drug products. The tour covered key production areas of the Singapore site, including production lines, as well as the advanced quality control center and machinery area. Guests highly praised the site’s advanced modular design, internationally leading process equipment, and strict quality control system.
The successful GMP release of the WuXi XDC Singapore site is an important milestone in the company’s history and solid support for providing end-to-end, one-stop services to more clients worldwide. In the future, the Singapore site will deeply integrate and collaborate with multiple domestic sites to build an integrated, multi-dimensional comprehensive network, continuously empowering partners and the innovative development of the bioconjugate industry.
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
