Harbour BioMed, Kelun-Biotech Secure China IND Approval for Bispecific Antibody in Asthma

16 July 2026 | Thursday | News


NMPA clearance enables clinical development of HBM7575/SKB575 in asthma, expanding the long-acting TSLP-targeting candidate’s development programme beyond atopic dermatitis.

Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, and Kelun-Biotech (6990.HK) announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7575/SKB575, a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target co-developed by the two parties,  for the treatment of asthma. Previously, the first participant has been dosed in a Phase 1 clinical study of HBM7575/SKB575 for the treatment of atopic dermatitis.

 Asthma is a chronic respiratory condition affecting approximately 300 million people worldwide, with prevalence continuing to rise. Despite the availability of treatment options, many patients experience persistent symptoms, frequent exacerbations, and reduced quality of life. Current therapies - mainly inhaled corticosteroids (ICS) and bronchodilators - are inadequate for some patients, underscoring the urgent need for more effective, long-acting treatments that address the underlying disease mechanisms.

"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." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented. "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."

 

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