Wuxi Biologics - WXXWY STOCK NEWS

WuXi Biologics has received a Manufacturing License from Japan's Minister of Health for its drug substance facility (MFG2) following a successful GMP inspection. The inspection covered quality processes and production systems without any issues, highlighting WuXi's regulatory compliance. This year, the company completed 12 inspections and nearly 20 overall by various agencies, including the U.S. FDA and EMA. The CEO emphasized the importance of their quality system for sustainable growth and global expansion.

WuXi Biologics reported a remarkable financial performance for the first half of 2021, with revenue rising 126.7% year-over-year to RMB4,406.8 million. Gross profit surged 191.7% to RMB2,296.8 million and the adjusted net profit increased 163.0% to RMB1,768.7 million. The company’s gross margin improved to 52.1%, while net profit margin rose to 42.7%. WuXi Biologics executed its Follow & Win the Molecule strategy successfully, expanding total integrated projects to 408, including significant contributions in vaccine manufacturing.

WuXi Biologics has received a second EMA GMP certificate for its Biosafety Testing facility in Suzhou, just 13 months after its first. This certification confirms the company's adherence to global biosafety testing standards. The EMA's approval follows a remote inspection by Poland's Chief Pharmaceutical Inspectorate in April 2021. WuXi Biologics’ CEO emphasized the importance of continuous improvement in their quality systems to support global partners in biotherapeutics development. The company has a strong track record, conducting over 500 biosafety studies without rejections.

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.