Harbour BioMed and Kelun-Biotech have received approval from China’s National Medical Products Administration for the Investigational New Drug application of HBM7575/SKB575 in asthma.
HBM7575/SKB575 is a long-acting bispecific antibody targeting thymic stromal lymphopoietin and an undisclosed second target. The candidate is being co-developed by the two companies for chronic immune-mediated diseases.
Asthma affects approximately 300 million people worldwide and continues to create significant disease burden despite available inhaled therapies and biologics. Many patients still experience persistent symptoms, exacerbations and reduced quality of life.
Current asthma therapies include inhaled corticosteroids, bronchodilators and biologics targeting selected inflammatory pathways. However, some patients remain uncontrolled, creating demand for treatments that address upstream disease mechanisms and broader inflammatory signalling.
TSLP is an epithelial cytokine involved in initiating and amplifying type 2 inflammation and other immune pathways in asthma. By targeting TSLP alongside a second undisclosed pathway, HBM7575/SKB575 is being positioned as a differentiated long-acting bispecific antibody for respiratory and immune-mediated disease.
The asthma IND approval follows recent first-participant dosing in a Phase 1 clinical study of HBM7575/SKB575 for atopic dermatitis. With two indications now cleared for clinical development, the programme is moving into a broader immunology strategy.
The collaboration structure is also relevant. Kelun-Biotech leads design, global development and commercialisation of SKB575/HBM7575, while Harbour BioMed participates in investment and development and shares benefits under the collaboration.
