Wuxi Biologics - WXXWY STOCK NEWS

WuXi Biologics announced regulatory approvals for its Drug Substance (DS) facilities and Drug Product (DP) facility in Wuxi, China, from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The MFG5 facility, with a capacity of 60,000L, and the DP2 facility received EMA GMP certificates within 10 months of starting GMP manufacturing. WuXi Biologics now holds 13 certified DS and DP facilities globally, expanding its capacity to support clients with commercial manufacturing. CEO Chris Chen emphasized the commitment to maintaining high global quality standards.

WuXi Biologics has announced the GMP release of its first North American biomanufacturing facility, MFG18, located in Cranbury, New Jersey. The facility has an initial capacity of 4,000L, expanding to 6,000L, and utilizes single-use technology. This strategic move positions WuXi closer to its U.S. customer base amidst a growing biopharma cluster. The site employs over 150 people, expected to rise to 250. This expansion aligns with WuXi's Global Dual Sourcing Strategy, enhancing its clinical manufacturing capacity and service capabilities worldwide.

WuXi Biologics reported impressive financial results for the first half of 2022, with revenue rising by 63.5% year-on-year to RMB 7,206.4 million. Gross profit increased by 48.6% to RMB 3,413.2 million, while net profit grew 39.2% to RMB 2,621.2 million. Adjusted net profit saw a 60.9% rise to RMB 2,914.9 million. The company's backlog reached US$ 18,467 million, indicating robust future growth. Non-COVID revenue surged by 72.6%, highlighting profitability across operations despite industry challenges.

WuXi Biologics (2269.HK) has been recognized as a constituent of the FTSE4Good Index Series, affirming its commitment to strong Environmental, Social, and Governance (ESG) practices. This inclusion highlights improvements in WuXi's ESG score, particularly in its GHG emissions intensity, which it aims to reduce by 50% by 2030 from 2020 levels. The company promotes renewable energy and collaborates with partners for sustainability. CEO Chris Chen emphasized their dedication to responsible corporate development aligned with global sustainability goals.

WuXi Biologics announced a USD$1.4 billion investment in a new CRDMO center in Singapore, enhancing its manufacturing capacity by adding 120,000L biomanufacturing capabilities by 2026. This center is poised to employ 1,500 staff and strengthen the company's global supply chain as part of its Global Dual Sourcing strategy. Supported by Singapore’s Economic Development Board, this investment emphasizes Singapore's role as a biopharmaceutical hub. WuXi Biologics aims to foster the local biotech ecosystem and support global healthcare partners.

WuXi Vaccines has received its first GMP certificate from the Ireland HPRA for its QC potency lab, a key milestone for manufacturing commercial vaccine products at its Dundalk facility. This certification supports a 20-year contract valued at approximately $3 billion USD with a top global pharmaceutical company. The QC lab has been operational since July 2020 and reflects WuXi's commitment to addressing global vaccine manufacturing challenges, especially in light of increased demand due to the COVID-19 pandemic.

WuXi XDC and AbTis have signed a Memorandum of Understanding to establish a strategic partnership focused on antibody-drug conjugates (ADCs). This collaboration enables AbTis to utilize WuXi XDC’s comprehensive services for linker and payload manufacturing, ADC conjugation, and drug product development. The proximity of their facilities enhances operational efficiency. Both companies aim to accelerate ADC product availability to patients, leveraging WuXi XDC's expertise in bioconjugates, demonstrated even during COVID-19 disruptions.

WuXi Biologics has expanded its CRDMO services by initiating cGMP manufacturing for microbial-derived products at its MFG14 facility in Hangzhou, China. This facility has four cGMP lines with fermentors from 30L to 2,000L, capable of end-to-end CMC services. The decision responds to increased market demand for microbial fermentation capacity, particularly in enzymes, plasmids, and vaccines. With over 10,000 employees and 526 client projects, WuXi aims to enhance its service offerings, facilitating faster and more cost-effective production for its partners.

WuXi Biologics has launched its GMP operation for DP5, a new drug product facility in Wuxi, China, enhancing its capacity to manufacture pre-filled syringes (PFS) to 17 million units annually. This facility, part of a global network of nine drug product sites, utilizes advanced technology to minimize contamination risks while providing flexible filling options such as 1 mL and 3 mL. CEO Chris Chen emphasized the significance of this milestone, positioning WuXi as a leader in drug product CDMO services and supporting clients from clinical trials to commercialization.