Chime Biologics, a global CDMO, and Mabgeek, a clinical-stage innovative antibody drug development biotech, have successfully completed Process Performance Qualification (PPQ) for MG-K10, a humanized anti-IL-4Rα monoclonal antibody.

This milestone propels the Phase III clinical trials for treating Th2-mediated inflammatory diseases such as moderate-to-severe atopic dermatitis (AD), asthma, rhinosinusitis, prurigo nodularis, esophagitis and chronic obstructive pulmonary disease (COPD).

Chime Biologics and Mabgeek’s strategic collaboration focuses on commercial manufacturing of cGMP 2000L drug substance, late-stage chemistry, manufacturing, and controls (CMC) development and biologics license application (BLA) to accelerate MG-K10’s commercialization.

This partnership merges Mabgeek’s monoclonal antibody expertise with Chime Biologics’ quality-by-design approach and risk management, accelerating development while ensuring global quality and compliance. MG-K10 is the only product verified in late clinical studies for dosing every four weeks (Q4W), addressing strong efficacy and patient adherence essential for success in American and European markets.

Dr. Jimmy Wei, President of Chime Biologics, noted, “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.”

Dr. Chenghai Zhang, CEO of Mabgeek, added, “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.”

With Phase III trials underway, this collaboration remains committed to delivering Best-in-Class treatments to the market.