NMPA Clears IND for HBM7575/SKB575, a Long-Acting TSLP Bispecific Antibody for Asthma
核心洞察
Harbour BioMed (搜索) and Kelun-Biotech (搜索) received NMPA IND approval for HBM7575/SKB575 (搜索), a long-acting bispecific antibody targeting TSLP (搜索) and an undisclosed target, for the treatment of asthma (搜索).
The bispecific antibody is engineered for subcutaneous administration with an anticipated human half-life supporting dosing intervals of more than three months, potentially offering a best-in-class profile.
Asthma (搜索) affects approximately 300 million people worldwide, and many patients continue to experience persistent symptoms despite current therapies such as inhaled corticosteroids and bronchodilators.
Harbour BioMed (搜索) and Kelun-Biotech (搜索) announced on July 15, 2026, that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for HBM7575/SKB575 (搜索), a long-acting bispecific antibody, for the treatment of asthma (搜索). The approval marks the second major indication cleared for clinical development of this asset, following the recent dosing of the first participant in a Phase I study for atopic dermatitis (搜索).
The co-developed molecule targets thymic stromal lymphopoietin (TSLP (搜索)) alongside an undisclosed antigen, employing a dual mechanism of action designed to achieve broader inflammation control than single-target approaches.
Dual-Target Mechanism and Differentiated Design
HBM7575/SKB575 (搜索) operates through two complementary pathways. By blocking the interaction between TSLP (搜索) and its receptor, the antibody inhibits TSLP-mediated signaling and the activation of Th2 immune cells. Simultaneously, binding to and blocking the undisclosed target generates a synergistic effect that may extend the breadth of inflammatory control.
The molecule has been engineered specifically for longer dosing intervals and convenient subcutaneous administration. Preclinical half-life data suggest the anticipated human half-life will support dosing intervals of more than three months, positioning HBM7575/SKB575 (搜索) as a potential best-in-class therapy.
Addressing a Persistent Unmet Need
Asthma (搜索) remains a significant global health challenge, affecting approximately 300 million people worldwide with prevalence continuing to rise. Despite the availability of inhaled corticosteroids (ICS) and bronchodilators, many patients experience persistent symptoms, frequent exacerbations, and reduced quality of life. Current therapies prove inadequate for a subset of patients, underscoring the urgent need for more effective, long-acting treatments that address underlying disease mechanisms.
Clinical Development Strategy
Under the collaboration agreement between the two companies, Kelun-Biotech (搜索) leads the design, global development, and commercialization of HBM7575/SKB575 (搜索), while Harbour BioMed (搜索) participates in investment and development, sharing in the benefits as agreed.
"Building on the recent first participant dosing for HBM7575/SKB575 (搜索) in atopic dermatitis (搜索), we are thrilled to see this molecule rapidly advancing into asthma (搜索) indication," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed (搜索). "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."
Dr. Michael Ge, CEO of Kelun-Biotech (搜索), added: "As a differentially designed and engineered bispecific antibody, SKB575/HBM7575 is expected to achieve potent inflammation control and broad patient coverage through its dual-target synergistic mechanism, whilst offering convenient administration. We will vigorously advance the development of this drug to fully realize its clinical value."
The rapid expansion from atopic dermatitis (搜索) into asthma (搜索) underscores the broad therapeutic potential of dual-target TSLP (搜索) blockade across chronic immune-mediated inflammatory conditions.