WUXI BIOLOGICS UNSP/ADR - WXXWY STOCK NEWS

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.

WuXi Biologics reported a remarkable financial performance for the first half of 2021, with revenue rising 126.7% year-over-year to RMB4,406.8 million. Gross profit surged 191.7% to RMB2,296.8 million and the adjusted net profit increased 163.0% to RMB1,768.7 million. The company’s gross margin improved to 52.1%, while net profit margin rose to 42.7%. WuXi Biologics executed its Follow & Win the Molecule strategy successfully, expanding total integrated projects to 408, including significant contributions in vaccine manufacturing.