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 reported robust financial performance for 2021, achieving a 83.3% growth in revenue to RMB10,290.1 million, driven by strong demand in both COVID-19 and non-COVID-19 projects. Gross profit surged 90.6% to RMB4,828.9 million, while net profit increased by 107.3% to RMB3,508.6 million. The adjusted net profit also saw a remarkable rise of 100.3%, indicating a solid operational efficiency. The total backlog rose 20.1% to US$13,597 million, reflecting sustainable growth and an increase in project numbers.
WuXi Biologics announced that two subsidiaries in Shanghai and Wuxi will be added to the U.S. Commerce Department's "Unverified List" on February 8, 2022, due to uncompleted end-use verifications for exported equipment. This follows a delay caused by the COVID-19 pandemic. The company emphasizes that this listing does not impact its business or services, as the equipment is not needed after facility construction. WuXi Biologics is compliant with all U.S. export regulations and welcomes inspections to expedite removal from the list.
WuXi Biologics has successfully completed a remote GMP inspection by South Korea's Ministry of Food and Drug Safety for its drug substance facility in Wuxi. This marks the completion of 23 regulatory inspections by major agencies, demonstrating compliance with global standards. The facility utilizes an innovative production approach combining multiple bioreactor harvests for efficient manufacturing. The company is involved in 480 integrated projects and plans to exceed 430,000 liters of production capacity by 2024 across multiple countries, reinforcing its commitment to high-quality biologics and sustainability.
WuXi Biologics and ImmuneOncia Therapeutics signed a Memorandum of Understanding (MOU) to collaborate on the development and manufacturing of IOH-001, a novel bispecific antibody targeting PD-L1 and CD47. ImmuneOncia will utilize WuXi's comprehensive services including cell line and culture development, manufacturing, and bioassay development for their Investigational New Drug (IND) application. This partnership positions both companies to enhance their capabilities in immuno-oncology, aiming for significant advancements in therapeutic solutions for patients, particularly in South Korea.
WuXi Biologics has achieved the first GMP production at its new 24,000L line within the MFG5 drug substance facility, enhancing its capacity to meet growing demand for biologics manufacturing. This expansion brings total biomanufacturing capacity to approximately 150,000L, ranking WuXi in the top 5 global CDMOs. The new line utilizes twelve 2000L single-use bioreactors, improving productivity and reducing costs. WuXiUP™ technology integrates continuous processes for higher yield and quality, supporting over 40 projects, including those in clinical trials and license applications.
WuXi Biologics has launched a new GMP drug product facility in Wuxi, China, enhancing its drug production capabilities. The 12,000m² facility, known as DP2, can produce up to 60 million vials annually for biologics and features advanced isolator filling lines. This expansion supports high-efficiency production and flexible drug manufacturing solutions, meeting evolving regulatory requirements. Additionally, a new automated Drug Product Packaging Center has been opened to improve packaging efficiency for both clinical and commercial projects. This initiative reflects WuXi Biologics' commitment to innovation in biologics manufacturing.
WuXi Biologics announced a successful remote GMP inspection by Health Canada for its drug substance facility in Wuxi, with no observations noted. This inspection is part of nearly 20 regulatory assessments conducted by various agencies, including the U.S. FDA and EMA, highlighting WuXi's commitment to quality. CEO Chris Chen emphasized the importance of maintaining global quality standards to facilitate life-saving treatments. The company is involved in 408 integrated projects and aims to enhance its biomanufacturing capacity exceeding 430,000 liters across multiple countries by 2024.
WuXi Biologics has received a Manufacturing License from Japan's Minister of Health for its drug substance facility (MFG2) following a successful GMP inspection. The inspection covered quality processes and production systems without any issues, highlighting WuXi's regulatory compliance. This year, the company completed 12 inspections and nearly 20 overall by various agencies, including the U.S. FDA and EMA. The CEO emphasized the importance of their quality system for sustainable growth and global expansion.
