Chime Biologics Supports Mabgeek to Enter the U.S. Phase III Trials for MG-K10

SHANGHAI, Feb. 21, 2025 /PRNewswire/ -- Chime Biologics, a leading global CDMO that enables its partners' success in biologics, today announced its continued collaboration with Mabgeek in advancing MG-K10, a potential Best-in-Class therapy, a novel IL-4Rα-targeting antibody drug for atopic dermatitis and asthma, into U.S. Phase III trials. Mabgeek had a successful End of Phase II meeting with the FDA, paving the way for its U.S. market entry.

Chime Biologics is committed to enabling Mabgeek in its strategic entry into the U.S. market and will continue to provide comprehensive CMC and regulatory support for the start of the Phase III clinical trials of MG-K10 after the positive End of Phase II meeting with the US FDA. This collaboration builds on the successful completion of the Process Performance Qualification (PPQ) milestone, which validated Chime Biologics' robust manufacturing standards and regulatory compliance necessary for the drug's advancement.

The strategic collaboration between Chime Biologics and Mabgeek, first announced in 2022, focusing on commercial manufacturing of cGMP 2000L drug substance and drug product, late-stage chemistry, manufacturing, and controls (CMC) development, and global registration for MG-K10. This novel therapy has the potential to compete with current blockbuster drug of the same class, which has achieved significant sales and market value.

Dr. Chenghai Zhang, CEO of Mabgeek, stated, "We are excited to bring MG-K10 to the U.S. market and Phase III trials. Its unique profile positions it as a potential leader in the IL-4Rα-targeting therapy market. We are currently preparing to initiate global multicenter clinical trials. Chime Biologics has been a reliable partner, impressing us with their technology and quality system. With their support, we're excited to enter the U.S. market and anticipate their ongoing backing in Phase III trials and beyond."

Dr. Jimmy Wei, President of Chime Biologics, added, "We are pleased to be a long-term partner with Mabgeek and are proud to support their journey to bring this innovative therapy to global patients in need. We are working with several clients on late-stage projects for U.S. and European marketing authorization. With our quality system that meets EU and US standards and our global regulatory experience, we are well-positioned to support Mabgeek's Phase III trials and market entry in the U.S., where we believe MG-K10 can make a significant impact."

About MG-K10

MG-K10 is an innovative long-acting anti-IL-4Rα humanized monoclonal antibody that simultaneously blocks the signaling of key type 2 inflammatory cytokines IL-4 and IL-13. Following Fc mutation, MG-K10 allows long dosing interval owing to its prolonged half-life, and it is expected to be the first long-acting anti-IL-4Rα monoclonal antibody marketed in China. The indication 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: www.mabge.com.

About Chime Biologics

Chime Biologics is a global leading 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 market registration 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: www.chimebiologics.com.

SOURCE Chime Biologics