Chime Biologics, a global contract development and manufacturing organisation (CDMO), alongside Mabgeek, a biotech firm specialising in antibody drug development for immuno-inflammatory diseases, has announced the completion of the Process Performance Qualification (PPQ) for MG-K10. This humanised anti-IL-4Rα monoclonal antibody is now set to enter Phase III clinical trials, aiming to treat a range of Th2-mediated inflammatory conditions, including moderate-to-severe atopic dermatitis (AD), asthma, rhinosinusitis, prurigo nodularis, esophagitis, and chronic obstructive pulmonary disease (COPD).
Dr. Chenghai Zhang, CEO of Mabgeek, highlighted the significance of this achievement, stating, "The successful PPQ for our pioneering MG-K10 antibody is a testament to the power of collaboration between us." He expressed confidence in entering the American and European markets, leveraging their innovation capabilities to meet unmet clinical needs in allergic inflammatory and autoimmune diseases.
The collaboration, which began in 2022, focuses on advancing MG-K10 through late-stage development and commercialisation. This includes manufacturing cGMP 2000L drug substances, developing robust chemistry, manufacturing, and controls (CMC) processes, and preparing for a biologics license application (BLA). The partnership combines Mabgeek's expertise in monoclonal antibody innovation with Chime Biologics’ adoption of quality-by-design principles and comprehensive risk management, aiming to streamline development timelines while maintaining high standards for quality and regulatory compliance.
MG-K10 is distinguished as the only drug in its category worldwide to progress to late-stage clinical trials with a once-every-four-weeks (Q4W) dosing schedule, addressing the need for strong therapeutic efficacy and excellent patient adherence. This positions MG-K10 for success in key global markets, including the United States and Europe.
Dr. Jimmy Wei, President of Chime Biologics, expressed delight at the successful completion of MG-K10’s PPQ, marking a significant milestone in their partnership and its potential in the global market. He emphasized Chime Biologics' commitment to international quality standards and delivering top-tier biopharmaceutical solutions that meet global regulatory requirements, aiming to accelerate the commercialisation of MG-K10 for transformative patient care worldwide.