Chime And Mabgeek Attained Process Performance Qualification Milestones For MG-K10

Chime Biologics, a leading global contract development and manufacturing organisation (CDMO), and Mabgeek, an innovative biotech specialising in antibody drug development for immuno-inflammatory diseases, have announced a significant milestone in their collaboration. They completed the Process Performance Qualification (PPQ) for MG-K10, a humanised anti-IL-4Rα monoclonal antibody. This achievement paves the way for Phase III clinical trials aimed at treating 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, commented,  “The successful PPQ for our pioneering MG-K10 antibody is a testament to the power of collaboration between us, and we are confident in entering the American and European markets, leveraging our strong innovation capabilities and commitment to meeting unmet clinical needs in allergic inflammatory diseases and autoimmune diseases. We will continue to advance this partnership with Chime Biologics to commercial manufacturing, aiming to broaden access to groundbreaking therapies for patients worldwide.”

The partnership between Chime Biologics and Mabgeek, 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). By blending Mabgeek's expertise in monoclonal antibody innovation with Chime Biologics’ adoption of quality-by-design principles and comprehensive risk management, the collaboration is streamlining development timelines while maintaining the highest standards for quality and regulatory compliance.

MG-K10 stands out as the only drug in its category worldwide to progress to late-stage clinical trials with a once-every-four-weeks (Q4W) dosing schedule. This unique feature addresses two critical needs: delivering strong therapeutic efficacy while promoting excellent patient adherence. These attributes position MG-K10 for success in key global markets, including the United States and Europe.

Dr. Jimmy Wei, President of Chime Biologics, said, “We are delighted with the successful completion of MG-K10’s PPQ. This achievement marks a significant milestone in our partnership and signals its immense potential in the global market. Chime Biologics holds international quality standards, reflecting our commitment to delivering top-tier biopharmaceutical solutions that align with global regulatory requirements. Through our partnership with Mabgeek, we are advancing therapeutic innovation to accelerate the commercialisation of MG-K10, ensuring patients worldwide receive transformative care sooner.”