Chime Biologics, a China-based global CDMO, and Mabgeek, a China-based clinical-stage antibody drug development biotech focusing on immuno-inflammation, announced on Friday that they have completed Process Performance Qualification (PPQ) for MG-K10, a humanised anti-IL-4R alpha monoclonal antibody.

This milestone accelerates 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, first unveiled in 2022, focuses on commercial manufacturing of cGMP 2000L drug substance, late-stage chemistry, manufacturing, and controls (CMC) development and biologics license application (BLA) to accelerate Best-in-Class biologics MG-K10's commercialisation.

Combining Mabgeek's expertise in monoclonal antibody innovation with Chime Biologics' adoption of the internationally recognised quality-by-design concept, risk management methodology, and robust CMC processes, this partnership will continue to speed up development timelines while maintaining rigorous global quality standards and regulatory compliance. MG-K10 is currently claimed to be the only pipeline product in this category worldwide that has been verified in late clinical study that can be dosed once every four weeks (Q4W), which the company says meets the two key needs of strong efficacy and excellent patient adherence, which is crucial for success in the American and European markets.