• Process Performance Qualification (PPQ) validates robust manufacturing standards and is crucial for regulatory compliance
• Marks a key step forward for the world's first once-monthly IL-4Rα-targeting antibody therapeutic for Th2-driven diseases, with a strategic focus on entering the American and European markets

Chime Biologics, a leading global CDMO that enables its partners' success in biologics, and Mabgeek, a clinical-stage innovative antibody drug development biotech focusing on immuno-inflammation,  announced the successful completion of 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, 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 commercialization.

Combining Mabgeek's expertise in monoclonal antibody innovation with Chime Biologics' adoption of the internationally recognized 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 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), meeting the two key needs of strong efficacy and excellent patient adherence, which is crucial for success in the 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. Chime Biologics upholds international quality standards, reflecting our commitment to delivering top-tier biopharmaceutical solutions that are in line with global regulatory requirements. Through our partnership with Mabgeek, we are advancing therapeutic innovation to accelerate the commercialization of MG-K10, ensuring patients worldwide receive transformative care sooner."

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."

With Phase III trials underway, this collaboration remains committed to delivering Best-in-Class treatments to the market. The PPQ milestone of MG-K10 highlights Chime Biologics' strategic approach to fostering global innovation through robust partnerships, with a particular emphasis on meeting the high standards required for success in the American and European markets.