- 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
SHANGHAI, Jan. 3, 2025 /PRNewswire/ -- 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, today 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.
About MG-K10
MG-K10, a novel and long-acting humanized IL-4Rα targeting mAb drug with half-life extended, has been confirmed to have potential in treating all Th2 related disease, including AD, asthma, rhinosinusitis, prurigo nodularis, esophagitis, COPD and so on. The Phase II clinical results of MG-K10 in both AD and asthma confirmed that it has the potential to be Best-in-Class. In the Phase II moderate-to-severe AD trial, MG-K10 highly improved patients' clinical signs and quality of life, while in the Phase II moderate-to-severe asthma trial, MG-K10 significantly improved lung function and clinical symptoms. While other launched anti-IL-4Rα therapeutics need to be dosed Q2W, MG-K10 is highly effective and well tolerated dosed Q4W. MG-K10 is in Phase III in AD, asthma and prurigo nodularis.
About Mabgeek
Mabgeek was founded in 2016, always adhering to the research and development concept of "innovation, efficiency and safety", focusing on the Immuno-Inflammation field. Mabgeek has a research and development team composed of top experts in the industry. With excellent research and development capabilities and deep industry accumulation, Mabgeek uses its unique TEADA hybridoma platform to develop differentiated and innovative monoclonal and bispecific antibody drugs with high biological activity and high drug yield, and is committed to bringing more safe, effective and convenient treatment to all patients globally. Other than MG-K10, Mabgeek also is studying anti-TSLP (half life more than 80 days) in Phase II clinical trial in asthma, and got IND approval for half life extended anti-MASP-2 mAb. For more information, please visit: .
About Chime Biologics
Chime Biologics is a leading global CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners' success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health. For more information, please visit: .