Wuxi Biologics - WXXWY STOCK NEWS

WuXi Biologics congratulated partner DualityBio on their exclusive licensing agreements with BioNTech for two antibody-drug conjugate (ADC) therapeutics focused on cancer and autoimmune diseases.

WuXi Bio provided technical services to support the development of these products through its integrated service platforms. WuXi's advanced technology platforms have helped clients secure partnerships and drive global collaborations in the biotech sector.

With over 12,000 employees across multiple countries, WuXi Biologics is committed to supporting diverse projects and advancing bioconjugate therapies. As of December 31, 2022, WuXi is managing 588 integrated client projects, including 17 in commercial manufacturing, showcasing its strong market position in the biologics sector.

WuXi Biologics has announced its partnership with Amicus Therapeutics in celebrating the European Commission's approval of Pombiliti™ (cipaglucosidase alfa) for adults with late-onset Pompe disease. This therapy, a combined treatment with miglustat, is a significant milestone achieved through WuXi's advanced manufacturing capabilities since the therapy's inception in 2012. The approval is based on clinical data from the Phase 3 PROPEL trial, which included a diverse patient population. WuXi Biologics continues to support commercialization through its global sourcing strategy, reinforcing its position as a leader in biologics development.

WuXi Biologics reported a 48.4% year-on-year revenue increase to RMB15,268.7 million for 2022, primarily driven by its successful "Follow and Win the Molecule" strategies, resulting in 136 new integrated projects. Gross profit rose by 39.2% to RMB6,724.0 million, with an adjusted net profit of RMB5,053.9 million, a 47.1% increase. Non-COVID revenue saw a robust 63% growth, contributing to a total backlog of US$20,571 million. The company maintained a strong operational resilience amid COVID challenges, ensuring project delivery and sustaining growth momentum, particularly in North America. Positive cash flow positions WuXi well for future expansion.

WuXi XDC, a global leader in CRDMO services, has announced that the Experimental Drug Development Centre (EDDC) in Singapore has received U.S. FDA clearance for EBC-129 to begin its first-in-human trial for solid tumors. This marks EBC-129 as Singapore's first antibody-drug conjugate (ADC). WuXi XDC facilitated the Investigational New Drug (IND) application with its advanced integrated technology platforms, ensuring high-quality results. CEO Jimmy Li praised the collaboration, emphasizing the role of CRDMOs in advancing clinical trials. WuXi XDC aims to streamline ADC development, achieving IND filings in under 15 months.

WuXi Biologics has signed a license agreement with GSK granting exclusive rights to one preclinical bi-specific T cell engaging antibody and options for three more. WuXi Biologics will receive an upfront payment of $40 million and could earn up to $1.46 billion from milestone payments. The agreement highlights GSK’s expansion into novel cancer therapies and validates WuXi's proprietary technology platforms. The CEO of WuXi emphasized the significance of this partnership in facilitating GSK's ability to develop potentially life-saving treatments for patients worldwide.

WuXi Biologics, a global leader in Contract Research, Development and Manufacturing, announced its subsidiary WuXi Biologics (Shanghai) Co., Ltd. was removed from the U.S. Department of Commerce's Unverified List (UVL), effective Dec. 16, 2022. This follows successful on-site checks by the Department in cooperation with China's Ministry of Commerce. Both subsidiaries faced UVL placement in February 2022 due to verification delays for U.S. exports, but since then, compliance has been reaffirmed. WuXi Biologics remains committed to high compliance standards and advancing its Environmental, Social, and Governance (ESG) initiatives.

WuXi Biologics has reported significant progress amid industry challenges, with 120 new projects signed in 2022 and similar goals for 2023. The company is reaffirming its growth targets for the year. A notable achievement includes a successful share repurchase of approximately US$300 million, acquiring over 50 million shares at HK$45.90 each. Additionally, its subsidiary was removed from the U.S. Department of Commerce's Unverified List after a successful site visit, enhancing compliance credibility. WuXi Biologics continues to position itself as a leader in ESG initiatives within its sector.

WuXi Biologics has launched its 11th GMP drug substance manufacturing facility, MFG8, in Shijiazhuang, Hebei Province, China. This new facility enhances production capabilities, allowing for commercial manufacturing at scales from 4,000L to 20,000L and project initiation within four weeks. MFG8 incorporates eco-friendly practices in line with WuXi's ESG commitments, featuring sustainable construction and a rooftop solar project to significantly reduce carbon emissions. The facility supports the growing global demand for contract biomanufacturing services and aims to provide reliable, flexible services in biologics manufacturing.