Welcome to our dedicated page for Wuxi Biologics news (Ticker: WXXWY), a resource for investors and traders seeking the latest updates and insights on Wuxi Biologics stock.
WuXi Biologics (WXXWY) provides comprehensive biologics development solutions through its global CRDMO platform. This news hub delivers essential updates for stakeholders tracking the company's operational milestones and industry impact.
Access timely reports on regulatory achievements, technology innovations, and strategic partnerships. Our curated collection includes earnings announcements, manufacturing capacity expansions, and GMP certification milestones across global facilities. Monitor developments in proprietary platforms like WuXiBody™ bispecific antibodies and WuXia™ cell line technologies.
This resource consolidates verified information from multiple sources, offering efficient tracking of the company's progress in biologics development. Regular updates ensure you stay informed about critical events affecting WXXWY's market position and service capabilities.
Bookmark this page for streamlined access to WuXi Biologics' latest developments. Combine these updates with financial filings and industry analysis for complete due diligence.
WuXi Biologics has been awarded the 2023 ISPE Facility of the Year Award (FOYA) in the Operations category for its manufacturing facility in Dundalk, Ireland. The facility, one of the largest of its kind in Europe, features two manufacturing areas with 6x1KL single-use bioreactors for perfusion and 12x4KL single-use bioreactors for fed-batch. Construction of the 467,500-square-foot greenfield facility began in December 2018 and operations started in December 2021, creating over 6,000 construction jobs and more than 500 highly skilled jobs in the region.
The facility received its first GMP certificate from the Irish Health Products Regulatory Authority (HPRA) just nine months after starting operations. In line with WuXi Biologics' ESG strategy, the site incorporates sustainable concepts, including 100% renewable energy power supply. This marks the second FOYA recognition for WuXi Biologics, following an Honorable Mention in 2014 for its facility in Wuxi city, China.
WuXi Biologics congratulated partner DualityBio on their exclusive licensing agreements with BioNTech for two antibody-drug conjugate (ADC) therapeutics focused on cancer and autoimmune diseases.
WuXi Bio provided technical services to support the development of these products through its integrated service platforms. WuXi's advanced technology platforms have helped clients secure partnerships and drive global collaborations in the biotech sector.
With over 12,000 employees across multiple countries, WuXi Biologics is committed to supporting diverse projects and advancing bioconjugate therapies. As of December 31, 2022, WuXi is managing 588 integrated client projects, including 17 in commercial manufacturing, showcasing its strong market position in the biologics sector.
WuXi Biologics has announced its partnership with Amicus Therapeutics in celebrating the European Commission's approval of Pombiliti™ (cipaglucosidase alfa) for adults with late-onset Pompe disease. This therapy, a combined treatment with miglustat, is a significant milestone achieved through WuXi's advanced manufacturing capabilities since the therapy's inception in 2012. The approval is based on clinical data from the Phase 3 PROPEL trial, which included a diverse patient population. WuXi Biologics continues to support commercialization through its global sourcing strategy, reinforcing its position as a leader in biologics development.
WuXi Biologics reported a 48.4% year-on-year revenue increase to RMB15,268.7 million for 2022, primarily driven by its successful "Follow and Win the Molecule" strategies, resulting in 136 new integrated projects. Gross profit rose by 39.2% to RMB6,724.0 million, with an adjusted net profit of RMB5,053.9 million, a 47.1% increase. Non-COVID revenue saw a robust 63% growth, contributing to a total backlog of US$20,571 million. The company maintained a strong operational resilience amid COVID challenges, ensuring project delivery and sustaining growth momentum, particularly in North America. Positive cash flow positions WuXi well for future expansion.
WuXi XDC, a global leader in CRDMO services, has announced that the Experimental Drug Development Centre (EDDC) in Singapore has received U.S. FDA clearance for EBC-129 to begin its first-in-human trial for solid tumors. This marks EBC-129 as Singapore's first antibody-drug conjugate (ADC). WuXi XDC facilitated the Investigational New Drug (IND) application with its advanced integrated technology platforms, ensuring high-quality results. CEO Jimmy Li praised the collaboration, emphasizing the role of CRDMOs in advancing clinical trials. WuXi XDC aims to streamline ADC development, achieving IND filings in under 15 months.
WuXi Biologics has signed a license agreement with GSK granting exclusive rights to one preclinical bi-specific T cell engaging antibody and options for three more. WuXi Biologics will receive an upfront payment of $40 million and could earn up to $1.46 billion from milestone payments. The agreement highlights GSK’s expansion into novel cancer therapies and validates WuXi's proprietary technology platforms. The CEO of WuXi emphasized the significance of this partnership in facilitating GSK's ability to develop potentially life-saving treatments for patients worldwide.
