WUXI BIOLOGICS UNSP/ADR - WXXWY STOCK NEWS

WuXi Biologics announced significant achievements at its Dundalk, Ireland facility, including successful completion of multiple 16,000-liter Process Performance Qualification (PPQ) runs and GMP approvals from HPRA for all three manufacturing facilities. The site achieved two PPQ runs with 100% success rate using innovative single-use technology, combining four 4,000-liter bioreactors to match the performance of traditional stainless-steel systems.

The facility, operational since March 2022, employs over 760 people and features three manufacturing suites: a 6,000L perfusion suite and a 48,000L fed-batch suite. The site received the ISPE Facility of the Year Award in 2023 and holds ISO certifications for energy management, environmental management, and occupational safety.

WuXi Biologics announced plans to enhance its drug product capabilities at its Leverkusen, Germany facility with a new sterile filling line for prefilled syringes (PFS). The new line will handle multiple syringe sizes at up to 400 syringes per minute, with an annual capacity of 17 million syringes. This adds to the existing filling and freeze-drying line's capacity of 10 million doses annually. Construction will begin recently with GMP compliance targeted for 2026. The expansion supports WuXi Bio's Global Dual Sourcing strategy and aims to meet growing client demand for drug product services.

WuXi Biologics has launched WuXia™ RidGS, a high-yield glutamine synthetase-knockout CHO expression system platform for non-antibiotic cell line development. The platform uses zinc finger nucleases technology and achieves average clonal expression levels exceeding 6 g/L for monoclonal antibodies. The system ensures cell line stability for various therapeutic modalities, including bispecific antibodies, Fc-fusion proteins, and recombinant proteins. WuXia™ RidGS maintains stable productivity and uniform product quality without antibiotics, featuring favorable glycosylation patterns and exceptional purity profiles.

WuXi Biologics (2269.HK) has received a Platinum Award from The Asset ESG Corporate Awards for the fourth consecutive year. This prestigious honor recognizes the company's commitment to sustainable practices and its effective approach to driving innovation and efficiency through green technology.

The Asset evaluates companies on various ESG metrics, including corporate governance, sustainability financing, supplier codes of conduct, energy consumption, GHG emissions, and waste and water management. WuXi Biologics is the only healthcare industry company among this year's winners.

The company has made significant progress in pursuing sustainable development and socially responsible policies, aligning with the United Nations Sustainable Development Goals. WuXi Biologics is a signatory to the UN Global Compact and the Science Based Targets initiative (SBTi) commitment letter.

WuXi Biologics' ESG efforts have been recognized by major rating agencies, receiving accolades such as an 'AAA' rating from MSCI ESG Ratings, a Platinum Medal from EcoVadis, and inclusion in various prestigious ESG indexes.

WuXi Biologics, a leading global CRDMO, has been included in the Hang Seng ESG 50 Index, effective September 9, 2024. It is the only pharmaceutical company selected this year. The index captures the performance of the top 50 ESG leaders with high market capitalization listed in Hong Kong.

In the 2024 HKQAA Sustainability Ratings, WuXi Biologics earned an A rating, ranking in the top 10% among industry peers in areas such as corporate governance, human rights, labor practices, environment, and community involvement.

The company has made significant progress in sustainable development, aligning with the UN Sustainable Development Goals. It is a signatory to the UN Global Compact and the Science Based Targets initiative. WuXi Biologics has also received recognition from major ESG rating agencies, including an AAA rating from MSCI ESG Ratings and a Platinum Medal from EcoVadis.

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.