WUXI BIOLOGICS UNSP/ADR - WXXWY STOCK NEWS

WuXi Biologics has announced receiving a License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. This marks the first GMP manufacturing authorization outside of China, showcasing its global quality standards. The facility qualified in just 12 months, illustrating the speed of its operations. Following a thorough inspection by Cologne's health authorities, the DP7 facility is set to commence commercial manufacturing of a key product next week, reinforcing WuXi’s commitment to delivering quality biologics.

WuXi XDC and LegoChem Biosciences have signed a Memorandum of Understanding (MOU) to form a strategic partnership for developing and manufacturing antibody-drug conjugates (ADCs). This partnership allows LCB access to XDC's comprehensive services, including mAb, linker, payload, and formulation development. With increasing outsourced demand for ADCs, the collaboration aims to advance LCB’s ADC products toward clinical trials and commercialization, ultimately making more effective treatments available to patients.

WuXi Biologics has entered into an exclusive contract development and manufacturing partnership with OncoC4 to support its full pipeline of biologics, including the late-stage project ONC-392, currently in Phase I trials in the U.S. and China. WuXi will provide comprehensive biologics development and cGMP manufacturing services, leveraging its proprietary WuXiBody® bispecific antibody platform for additional research. This partnership builds on a multi-year relationship, aiming to enhance the availability of life-saving therapies globally.

WuXi Biologics and WuXi STA announced the establishment of WuXi XDC, a joint venture aimed at providing end-to-end contract development and manufacturing services for bioconjugates, including antibody-drug conjugates (ADCs). WuXi Biologics will own 60% and WuXi STA 40%, with respective capital contributions of USD120 million and USD80 million. The new venture, led by CEO Jimmy Li, aims to expedite drug development and provide comprehensive services to partners, addressing challenges in the global supply chain for bioconjugates.

WuXi Biologics has successfully completed a Pre-License Inspection (PLI) and a routine GMP inspection by the U.S. FDA at its facilities in Wuxi, China. Over 15 working days, nine inspectors evaluated manufacturing, laboratory, and quality systems, confirming compliance with global standards. This represents a significant milestone for WuXi Biologics, enhancing its capacity for late-stage clinical and commercial manufacturing. The company has completed ten inspections since 2017, establishing itself as the only biologics company certified for commercial manufacturing in China.

WuXi Biologics reported a strong financial performance for 2020, with revenue increasing by 40.9% year-on-year to RMB5,612 million. Gross profit rose by 52.7% to RMB2,533 million, achieving a record-high gross margin of 45.1%. Net profit surged by 67.5% to RMB1,693 million, with a net profit margin of 30.2%. The Group successfully expanded its project backlog by 122% to US$11.3 billion and added 103 new integrated projects, bringing the total to 334. The execution of its "Win-the-Molecule" strategy and strong COVID-19 project engagements significantly boosted growth.

WuXi Biologics has announced a deal to acquire a 90% stake in CMAB Biopharma Group from CBC Group and associates, with the transaction anticipated to close in Q2 2021. This acquisition enhances WuXi's capacity by 7,000L in drug substance and drug product, expanding its global manufacturing network. The partnership aims to improve service offerings for CBC's portfolio companies in biologics development and manufacturing. The acquisition signifies a strategic push to strengthen WuXi's position in the biologics market.

WuXi Biologics has signed an equity agreement to acquire Pfizer China's biologics manufacturing facilities in Hangzhou. The 50,000 m² state-of-the-art site, GMP operational since 2018, will enhance WuXi's Drug Substance and Drug Product capacities. The acquisition is expected to close in the first half of 2021, enabling WuXi to address increasing global manufacturing demands. The facility includes advanced bioreactor capabilities and a skilled workforce, which will expedite production for various biopharmaceutical projects.