Chime Biologics, a leading global CDMO that enables its partners' success in biologics, 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."