Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, and Kelun-Biotech (6990.HK) today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7575/SKB575, a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target co-developed by the two parties, for the treatment of atopic dermatitis.

Atopic dermatitis is a chronic, inflammatory skin disease characterized by persistent itching, redness, and irritation. It affects around 20% of children and up to 10% of adults worldwide^[1]. Though not infectious, atopic dermatitis has a profound impact on patients' quality of life due to its cyclical nature of flare-ups and remissions. Current treatments, including topical corticosteroids, biologics, and Janus kinase (JAK) inhibitors, provide symptomatic relief for many patients, but often fail to deliver sustained disease control, especially in moderate-to-severe cases. Therefore, there is an urgent need for safer, more effective, and durable treatments that address underlying disease mechanisms and improve long-term outcomes.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "The NMPA's IND approval for HBM7575/SKB575 marks an important step forward in addressing the significant unmet needs in autoimmune diseases such as atopic dermatitis. By targeting TSLP, a key upstream driver of type 2 inflammation, and an undisclosed target, HBM7575/SKB575 has the potential to be a best-in-class, bispecific antibody for this disease. We look forward to advancing this investigational therapy through clinical development and believe its long-acting profile may offer a differentiated treatment option for patients worldwide."

Dr. Michael Ge, CEO of Kelun-biotech, stated: "We are delighted to see the approval of SKB575/HBM7575 for clinical trials in atopic dermatitis. This marks an important milestone in our strategic expansion in the field of autoimmune diseases and holds promise for offering a novel therapeutic option to patients with atopic dermatitis. As a bispecific antibody with a differentiated innovative mechanism and a long-acting profile, SKB575/HBM7575 holds the potential to deliver durable and stable disease control while improving patient treatment experience through reduced dosing frequency."