Chime Biologics and Mabgeek Advance MG-K10 to Phase III Trials

• Chime Biologics is continuing its partnership with Mabgeek to advance MG-K10, an IL-4Rα-targeting antibody for atopic dermatitis and asthma, into Phase III trials.

• Mabgeek has successfully completed an FDA meeting, positioning MG-K10 for entry into the U.S. market, with Chime Biologics providing CMC and regulatory support.

Chime Biologics has reaffirmed its commitment to Mabgeek in advancing MG-K10, a novel IL-4Rα-targeting antibody drug for atopic dermatitis and asthma, into Phase III clinical trials. This collaboration follows Mabgeek’s successful engagement with the U.S. Food and Drug Administration (FDA), paving the way for the therapy’s U.S. market entry.

The partnership, which began in 2022, focuses on late-stage CMC development, global registration, and commercial manufacturing of cGMP 2000L drug substance and drug product. Following a successful Process Performance Qualification (PPQ), Chime Biologics continues to provide comprehensive CMC and regulatory support for the upcoming Phase III trials.

MG-K10 is positioned as a potential competitor to an existing blockbuster therapy in the same class. With Mabgeek preparing to initiate global multicenter clinical trials in the U.S. and China, the company’s CEO, Dr. Chenghai Zhang, expressed confidence in MG-K10’s market potential and acknowledged Chime Biologics’ technological expertise and quality systems. “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,” said Zhang.

Dr. Jimmy Wei, President of Chime Biologics, reiterated the company’s commitment to supporting Mabgeek’s clinical and regulatory milestones. He highlighted the significance of MG-K10’s development and its potential impact on the market, stating, “We are pleased to be a long-term partner with Mabgeek and are proud to support their journey to bring this innovative therapy to patients in need.”