Wuxi Biologics - WXXWY STOCK NEWS

WuXi Biologics (WXXWY) has successfully completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing using its proprietary WuXiUI™ ultra-intensified fed-batch platform. The platform achieved a 4-fold productivity improvement compared to traditional fed-batch processes, with a titer of 18 g/L. This advancement, combined with enhanced downstream technology, resulted in a 50% reduction in downstream processing time and a final DS yield of 70%. The improvements led to significant reductions in manufacturing COGS and waste generation. The success of WuXiUI™, launched in 2023, demonstrates its readiness for larger-scale production and its potential to meet growing demand for therapeutic proteins and antibodies with lower costs and a reduced carbon footprint.

WuXi Biologics reported solid 2024 interim results with revenue increasing by 1.0% YoY to RMB 8,574.2 million. Non-COVID revenue grew by 7.7% YoY, with non-COVID late-phase & commercial manufacturing up 11.7%. The company added 61 new integrated projects, bringing the total to 742. Notable achievements include successful EMA inspections of 13 products and FDA inspections of 2 products. The company's backlog reached US$20.1 billion, providing high visibility for near-term revenue. Despite challenges, WuXi Biologics maintained strong business fundamentals, showcasing resilience in its CRDMO model and 'Follow and Win the Molecule' strategy. The company continues to expand globally, with progress in Ireland and Singapore facilities.

WuXi Biologics (WXXWY) and Medigene AG have entered into a three-year strategic partnership to design and co-research T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for treating difficult-to-treat tumors. The collaboration combines Medigene's 3S (sensitive, specific and safe) TCR generation and characterization capabilities with WuXi Biologics' unique anti-CD3 mAb, TCE platform, and WuXiBody™ bispecific antibody platform. This partnership aims to enhance WuXi Biologics' research service capabilities and apply Medigene's TCRs to new modalities, potentially creating additional value for patients and shareholders beyond TCR-T therapies.

WuXi Biologics (WXXWY) announced that four of its manufacturing facilities and its Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA). This certification covers commercial and NDA-ready manufacturing and services for eight biologics. The Suzhou center was certified for services related to ten novel therapies.

The company has a strong track record in quality compliance, having passed 35 global regulatory agency inspections, over 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons since 2017. WuXi Biologics currently has 15 GMP-certified drug substance and drug product facilities in its global network.

WuXi Biologics (WXXWY) has been named a constituent of the FTSE4Good Index Series for the fourth consecutive year, recognizing its superior sustainability performance. Launched by FTSE Russell, part of the London Stock Exchange Group, the index evaluates over 8,000 securities globally. WuXi Biologics improved its FTSE Russell ESG score to the top 7% in its industry. The company has also been added to the S&P Dow Jones Sustainability World Index and Emerging Markets Index, earned an 'AAA' MSCI ESG rating, and received other prestigious recognitions such as the Platinum Medal by EcoVadis and top ratings from Sustainalytics and CDP.

WuXi Biologics released its 2023 ESG Report, showcasing significant progress in sustainability initiatives. The company achieved reductions in greenhouse gas emissions and water consumption intensity, recognized by major ESG rating agencies. WuXi Biologics demonstrated commitment to ESG goals, governance, climate change action, value chain sustainability, diversity, and corporate social responsibility.