WUXI BIOLOGICS UNSP/ADR - WXXWY STOCK NEWS

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.

WuXi Biologics (2269.HK) has been recognized for its leadership in corporate transparency and performance on water security by CDP, securing a spot on its annual 'A List'. The company achieved an 'A' score in the Water Security category, placing it in the top 2% of over 23,000 evaluated companies. CEO Dr. Chris Chen highlighted sustainability as a key focus for the company's development.

WuXi Biologics achieves Leadership level recognition in 2023 Climate Change Assessment by CDP with an 'A-' score, surpassing sector and regional averages. The company's proactive efforts in environmental management and transparency are highlighted, with a commitment to science-based carbon targets and emission-reduction roadmaps.

WuXi Biologics (2269.HK) has been named a 2024 Industry Top-Rated and Regional Top-Rated Company by Morningstar Sustainalytics for the fourth consecutive year. The company ranks in the top 2% of nearly 1,000 companies in the pharmaceutical sector, showcasing strong ESG achievements.

WuXi Biologics successfully completes the first manufacturing run at its drug substance facility MFG7 in Ireland, achieving the largest manufacturing scale to date by combining four 4,000-liter single-use bioreactors. The Cost of Goods (COGS) from this run is comparable to that of a 16,000-liter traditional stainless-steel bioreactor, reinforcing the comparable cost seen in over 100 runs at 12,000-liter scale single-use bioreactors. The Ireland site also received the Facility of the Year Award (FOYA) in the Operations category from ISPE in 2023 and attained ISO certifications for energy management, environmental management, and occupational health and safety management.

WuXi Biologics launches WuXiaADCC PLUSTM, a high-yielding mammalian cell line platform for the development and manufacturing of afucosylated antibodies to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) response, crucial for targeted antibody-based immunotherapy approaches.

WuXi Biologics announced the granting of a patent for their WuXiBodyTM platform, a highly flexible engineering platform that enhances the characteristics of bispecifics. The platform has been granted patents in the U.S., Japan, and China and has been widely adopted globally since its launch in 2018. WuXiBodyTM can effectively break through the CMC barriers for the development of bispecific antibodies, shorten the process by 6-18 months, and significantly reduce manufacturing costs compared to other platforms. The platform enables almost any mAb sequence pairs to be assembled into bispecific constructs with low immunogenicity risk and a long in vivo half-life. As of December 31, 2023, there are 45 out-licensed WuXiBodyTM projects in various stages, with four in Phase Ⅰ clinical development. Two WuXiBodyTM projects are expected to have IND applications approved in 2024.