Chime Biologics Aids Mabgeek in U.S. Phase III Trials for MG-K10

Chime Biologics, a prominent global contract development and manufacturing organization (CDMO) based in Shanghai, has announced the continuation of its partnership with Mabgeek to advance MG-K10. This novel therapy, an IL-4Rα-targeting antibody drug, is poised to enter Phase III clinical trials in the United States, aiming to treat conditions such as atopic dermatitis and asthma. Following a successful meeting with the U.S. Food and Drug Administration (FDA) at the end of Phase II, Mabgeek is on track to introduce MG-K10 into the U.S. market.

Chime Biologics is devoted to supporting Mabgeek's strategic U.S. market entry by providing comprehensive chemistry, manufacturing, and controls (CMC) and regulatory assistance for the impending Phase III clinical trials. This backing follows the successful Process Performance Qualification (PPQ), which affirmed Chime Biologics' high manufacturing standards and regulatory adherence essential for the drug's progression.

The collaboration between Chime Biologics and Mabgeek, initiated in 2022, concentrates on the commercial production of cGMP 2000L drug substances and products, late-stage CMC development, and global registration for MG-K10. This innovative therapy is expected to rival existing blockbuster drugs in its class, which have garnered substantial sales and market presence.

Dr. Chenghai Zhang, Mabgeek’s CEO, expressed enthusiasm about introducing MG-K10 to the U.S. market and commencing Phase III trials. He highlighted the drug's potential leadership in the IL-4Rα-targeting therapy segment, driven by its unique profile. Mabgeek is preparing for global multicenter clinical trials and has praised Chime Biologics for their consistent support and advanced technological systems. Dr. Zhang anticipates continued collaboration with Chime Biologics throughout the U.S. market entry and subsequent Phase III trials.

Dr. Jimmy Wei, President of Chime Biologics, emphasized their long-standing partnership with Mabgeek and expressed pride in supporting the innovative therapy's journey to reach global patients in need. Chime Biologics is involved in several late-stage projects aimed at obtaining marketing authorization in the U.S. and Europe. With a quality system meeting EU and U.S. standards and extensive global regulatory expertise, the organization is well-prepared to support MG-K10's Phase III trials and U.S. market entry, where it is expected to have a significant impact.

MG-K10 is a groundbreaking long-acting anti-IL-4Rα humanized monoclonal antibody that blocks the signaling of crucial type 2 inflammatory cytokines IL-4 and IL-13. Thanks to Fc mutation, MG-K10 boasts an extended half-life, allowing for longer dosing intervals. It is anticipated to be the first long-acting anti-IL-4Rα monoclonal antibody available in China, addressing conditions such as asthma, rhinosinusitis, prurigo nodularis, esophagitis, and COPD. Phase II clinical results have demonstrated MG-K10’s potential as a Best-in-Class therapy, significantly enhancing patients' clinical signs and quality of life in trials for both atopic dermatitis and asthma. Unlike other therapies requiring biweekly dosing, MG-K10 is highly effective and well-tolerated with a monthly dosing schedule. Currently, MG-K10 is in Phase III trials for atopic dermatitis, asthma, and prurigo nodularis.

Mabgeek, established in 2016, focuses on the immuno-inflammation field, adhering to a research and development philosophy centered on innovation, efficiency, and safety. Their team of top industry experts leverages the unique TEADA hybridoma platform to develop distinctive and innovative monoclonal and bispecific antibody drugs with high biological activity and yield. Mabgeek is committed to delivering safe, effective, and convenient treatments globally. In addition to MG-K10, Mabgeek is investigating an anti-TSLP therapy in Phase II trials for asthma and has secured Investigational New Drug (IND) approval for an extended half-life anti-MASP-2 monoclonal antibody.

Chime Biologics, recognized for its pioneering modular biopharmaceutical plant KUBio™, supports partners throughout the entire biologics development process, from cell line creation to commercial manufacturing. Based in Shanghai and Wuhan, the organization offers a comprehensive CMC solution to biopharmaceutical clients worldwide, aiming to make cutting-edge biomedicines affordable and accessible globally, in line with its commitment to human health.