WuXi XDC Cayman Inc, a leading global Contract Research, Development and Manufacturing Organization (CRDMO) focused on the bioconjugate industry, announced that the mechanical completion of its manufacturing site at Tuas Biomedical Park in Singapore has been successfully achieved. This milestone signifies that this manufacturing site, spanning approximately 25,000 square meters, will now officially transition into the facility C&Q (Commissioning and Qualification) stage. The Singapore site is expected to commence operations by the end of 2025 and Good Manufacturing Practice (GMP) manufacturing in 2026. Upon that, the site will offer comprehensive production capabilities from the preclinical stage to commercialization.

As a critical component of WuXi XDC's global strategy, the Singapore site has demonstrated exceptional progress, adhering to the perfect execution and the "WuXi Speed" to provide customers with agile and flexible end-to-end CRDMO services. According to current capacity plan, the site is anticipated to create more than 500 job opportunities and over 100 people have joined our company so far.

Dr. Jimmy Li, CEO of WuXi XDC, stated, " The rapid mechanical completion of our Singapore site marks a critical pillar in our 'Global Dual-Sourcing' strategy. This global site will form a worldwide network alongside our Wuxi, Changzhou, and Shanghai sites, delivering end-to-end CRDMO services to global customers. This accomplishment showcases the full support of the partners for the construction of Singapore site, our deep understanding of global market demands, our ability to respond swiftly and the robust execution capabilities of our team. Looking ahead, we remain committed to advancing our one-stop model and global supply network, collaborating with global partners to promote the diversified and sustainable development of bioconjugates."

The Singapore site serves as a world-class, one-stop bioconjugates manufacturing center, integrating antibody intermediates, drug substance (DS), and drug products (DP). It strictly adheres to international certification standards and utilizes an advanced modular factory design. Key features include state-of-the-art antibody intermediates production lines, bioconjugate DS and DP production lines, MSAT lab, quality control, intelligent warehousing, and other utility support areas. Equipped with cutting-edge isolator filling lines, fully automated material transfer systems, and digital production management systems, the Singapore site supports multi-level demands ranging from small-scale clinical supplies to large-scale commercial manufacturing, including up to 2,000 liters per batch of mAb/DS, and 8 million vials of DP per year. These capabilities ensure the efficient advancement of projects across various stages while maintaining adherence to the highest quality standards.

The Singapore site will be operated under the highest international quality assurance standards, fully complying with Good Manufacturing Practice (GMP) regulations established by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and China's National Medical Products Administration (NMPA). This ensures comprehensive compliance throughout the production process, from antibody intermediates and DS to DP, enabling seamless product release globally. Additionally, the site incorporates environmentally friendly practices, utilizing certified eco-friendly products and implementing strict recycling and waste disposal systems to promote sustainability and enhance the company's ESG management level.