CHENGDU, China, July 15, 2026
Kelun-Biotech and Harbour BioMed have announced that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for SKB575/HBM7575, an investigational long-acting bispecific antibody being developed for the treatment of asthma. The regulatory approval marks a significant milestone in the clinical advancement of the next-generation immunology therapy and expands the development program of the candidate beyond its ongoing Phase I clinical trial in atopic dermatitis. Designed to address persistent inflammation through a dual-target mechanism, SKB575/HBM7575 represents an innovative biologic aimed at improving outcomes for patients whose asthma remains inadequately controlled with existing therapies. Asthma affects approximately 300 million people worldwide, and despite the widespread use of inhaled corticosteroids and bronchodilators, many patients continue to experience severe symptoms, frequent exacerbations, and reduced quality of life. The latest IND approval positions the investigational therapy as a promising candidate in the growing field of bispecific antibody therapeutics for chronic immune-mediated diseases.
Bispecific Antibody Designed for Long-Lasting Inflammation Control
SKB575/HBM7575 is a long-acting bispecific antibody engineered to simultaneously target thymic stromal lymphopoietin (TSLP) and an additional undisclosed inflammatory target, providing a dual mechanism intended to deliver broader and more durable control of airway inflammation than conventional single-target therapies. By blocking the interaction between TSLP and its receptor, the therapy suppresses activation of Th2 immune pathways, which play a central role in asthma and other allergic inflammatory diseases. Simultaneously, inhibition of the second undisclosed target is expected to generate a synergistic anti-inflammatory effect, potentially improving therapeutic outcomes across a wider patient population. The antibody has also been specifically engineered to achieve an extended half-life, supporting subcutaneous administration with anticipated dosing intervals exceeding three months. If confirmed in clinical studies, this long-acting profile could reduce treatment burden while improving patient adherence and disease management compared with currently available biologic therapies.
Clinical Development Expands Across Immune-Mediated Diseases
The NMPA IND approval enables Kelun-Biotech to begin clinical evaluation of SKB575/HBM7575 in asthma while continuing development in atopic dermatitis, where the first participant has already been dosed in an ongoing Phase I clinical trial. According to Dr. Michael Ge, Chief Executive Officer of Kelun-Biotech, the therapy’s differentiated molecular design and dual-target mechanism have the potential to provide potent inflammation control, broad patient coverage, and convenient long-interval dosing, supporting its potential as a best-in-class biologic for chronic inflammatory diseases.
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Under the strategic collaboration agreement, Kelun-Biotech leads the global design, clinical development, and commercialization of SKB575/HBM7575, while Harbour BioMed contributes to development and shares in future commercial benefits. The partnership combines Kelun-Biotech’s extensive expertise in innovative biologics with Harbour BioMed’s proprietary Harbour Mice® antibody discovery platform and advanced bispecific antibody technologies. As demand continues to grow for targeted biologic therapies capable of delivering greater efficacy with fewer treatment administrations, the advancement of SKB575/HBM7575 highlights ongoing innovation in respiratory medicine and immunology. The latest regulatory milestone reinforces China’s expanding role in global biopharmaceutical research, while positioning the investigational therapy as a promising candidate capable of addressing significant unmet needs among patients living with moderate to severe asthma and other chronic inflammatory disorders.
Source: Kelun-Biotech, Harbour BioMed press release
