Harbour BioMed and Kelun-Biotech have received approval from China’s National Medical Products Administration (NMPA) for their investigational new drug (IND) application for the HBM7575/SKB575 bispecific antibody intended to treat asthma.
HBM7575/SKB575 is designed to target thymic stromal lymphopoietin (TSLP) as well as an undisclosed antigen.
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The long-acting antibody uses a dual mechanism of action. It works to block the interaction between TSLP and its receptor, thereby inhibiting signalling pathways and the activation of Th2 immune cells.
In addition, the antibody binds to and blocks an undisclosed target, which the companies believe could achieve broader control over inflammation compared with single-target methods.
Kelun-Biotech leads the global development, design, and commercialisation of HBM7575/SKB575 while Harbour BioMed participates in its investment and development under a collaboration.
Financial terms and further clinical plans were not disclosed. The first participant has already been dosed with HBM7575/SKB575 in a Phase I clinical study for atopic dermatitis.
Harbour BioMed founder, chairman and CEO Dr Jingsong Wang said: “Building on the recent first participant dosing for HBM7575/SKB575 in atopic dermatitis, we are thrilled to see this molecule rapidly advancing into asthma indication.
“With two major indications now cleared for clinical development, we look forward to executing our clinical plan and exploring the full potential of this molecule to redefine treatment paradigms for chronic immune-mediated conditions.”
Despite existing treatments for asthma, many patients still suffer from ongoing symptoms, frequent exacerbations, and diminished quality of life. Current therapies, primarily inhaled corticosteroids (ICS) and bronchodilators, are not adequate for some individuals, highlighting the urgent need for long-lasting treatments that target the root causes of the disease.
In November 2025, Harbour BioMed and Evinova China formed a collaboration to implement AI and digital technologies to improve biologics development.
The partnership aimed to enhance the efficiency of AI-enabled drug development and create an open ecosystem for research and development.
