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Kelun-Biotech and Harbour BioMed Secure IND Approval for Asthma Drug

Kelun-Biotech and Harbour BioMed Secure IND Approval for Asthma Drug

China's National Medical Products Administration has cleared the Investigational New Drug application for SKB575/HBM7575, a bispecific antibody designed to treat asthma. This regulatory green light allows the co-developers to expand the testing of the drug, which is already undergoing Phase I clinical trials for atopic dermatitis.

The drug targets TSLP and an undisclosed secondary antigen to disrupt inflammatory signaling pathways. By blocking TSLP and utilizing a dual-target mechanism, the developers aim to provide more comprehensive inflammation control than current single-target therapies. Preclinical data suggests a long half-life, potentially enabling dosing intervals exceeding three months via subcutaneous injection.

Kelun-Biotech leads the global development and commercialization efforts for the asset, with Harbour BioMed providing investment and collaborative support. Dr. Michael Ge, CEO of Kelun-Biotech, noted that the therapy's design aims to address the limitations of existing inhaled corticosteroids and bronchodilators. With clinical trials now active for both asthma and atopic dermatitis, the companies are moving to establish the drug's clinical efficacy in chronic immune-mediated conditions.

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