Kelun-Biotech and Harbour BioMed have announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for SKB575/HBM7575, 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 characterised by persistent itching, redness, and irritation. It affects around 20% of children and up to 10% of adults worldwide.
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.
SKB575/HBM7575 is a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed antigen, with a dual mechanism of action.
On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signalling pathways and the activation of Th2 immune cells.
On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, overcoming resistance issues associated with TSLP single-target antibodies.
SKB575/HBM7575 has been engineered to possess an extended half-life and favourable developability, enabling subcutaneous administration.
Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.
According to the collaboration agreement between the company and Harbour BioMed, SKB575/HBM7575 is led by Kelun-Biotech in its design, global development and commercialisation, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.
