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Harbour BioMed and Kelun-Biotech Secure NMPA Nod for Asthma Drug Trial

China's National Medical Products Administration has cleared the Investigational New Drug application for HBM7575/SKB575, a long-acting bispecific antibody developed by Harbour BioMed and Kelun-Biotech. This regulatory green light allows the partners to begin clinical trials for asthma, expanding the molecule's reach beyond its ongoing study for atopic dermatitis.

Harbour BioMed and Kelun-Biotech Secure NMPA Nod for Asthma Drug Trial

The drug targets thymic stromal lymphopoietin (TSLP) alongside an undisclosed secondary antigen. By hitting two targets simultaneously, the antibody aims to provide broader inflammation control than existing single-target therapies. Engineers designed the molecule for subcutaneous administration, with preclinical data suggesting a half-life capable of supporting dosing intervals exceeding three months.

Asthma remains a significant global health challenge, impacting roughly 300 million people. Despite the widespread use of inhaled corticosteroids and bronchodilators, many patients continue to struggle with persistent symptoms and frequent exacerbations. Dr. Jingsong Wang, CEO of Harbour BioMed, stated that the company intends to prioritize the clinical plan to redefine treatment paradigms for chronic immune-mediated conditions. Under the current partnership agreement, Kelun-Biotech leads the global development and commercialization of the asset, while Harbour BioMed contributes to investment and development efforts.

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