- Chime Biologics has successfully completed Process Performance Qualification (PPQ) for MG-K10, a monoclonal antibody targeting Th2-mediated inflammatory diseases.
- This achievement propels Phase III trials for conditions like moderate-to-severe atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD).
Chime Biologics, a global contract development and manufacturing organisation (CDMO), has reached a significant milestone with the completion of Process Performance Qualification (PPQ) for MG-K10, an innovative humanized anti-IL-4Rα monoclonal antibody. The milestone propels the progression of Phase III clinical trials for MG-K10, which targets various Th2-mediated inflammatory diseases such as atopic dermatitis, asthma, and COPD.
The strategic collaboration between Chime Biologics and Mabgeek, first announced in 2022, aims to accelerate the commercial manufacturing and development of MG-K10. The partnership focuses on cGMP 2000L drug substance production, late-stage chemistry, manufacturing, and controls (CMC) development, as well as biologics license application (BLA) processes.
Through their combined expertise, the collaboration incorporates Chime Biologics’ quality-by-design approach and rigorous risk management, ensuring compliance with global regulatory standards while shortening development timelines. MG-K10, currently the only pipeline product in this category with a verified once-every-four-week dosing schedule, is positioned for strong patient adherence and efficacy, essential for success in the competitive American and European markets.
Dr. Jimmy Wei, President of Chime Biologics, commented, “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, stated, “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.”
As Phase III trials progress, Chime Biologics and Mabgeek continue their commitment to delivering best-in-class biologic treatments to the market, with the goal of improving patient outcomes and meeting urgent clinical needs in immuno-inflammatory conditions.
Stay ahead of trends and best practices
