Harbour BioMed and Kelun-Biotech have received approval from China’s National Medical Products Administration to begin clinical development of HBM7575/SKB575 for asthma.
The investigational candidate is a long-acting bispecific antibody targeting thymic stromal lymphopoietin, or TSLP, and a second undisclosed target.
TSLP is an epithelial cytokine associated with the initiation and persistence of inflammatory responses in asthma and other immune-mediated conditions.
By addressing two inflammatory pathways within a single molecule, HBM7575/SKB575 is being developed to provide broader control of disease activity than therapies targeting a single mechanism.
The companies previously received Chinese investigational new drug approval to evaluate the candidate in atopic dermatitis.
The first participant has since been dosed in a Phase I clinical study of HBM7575/SKB575 for that indication.
The new asthma clearance expands the clinical development programme into a chronic respiratory condition affecting approximately 300 million people globally.
Despite the availability of inhaled therapies and biologics, some patients continue to experience persistent symptoms, recurrent exacerbations and reduced quality of life.
Harbour BioMed and Kelun-Biotech are jointly developing HBM7575/SKB575 under a partnership combining Harbour BioMed’s antibody discovery capabilities with Kelun-Biotech’s drug-development and commercialisation infrastructure.
