Harbour BioMed and Kelun-Biotech Receive NMPA Approval for Novel Bispecific Antibody Targeting Atopic Dermatitis
Key Insights
Harbour BioMed (search) and Kelun-Biotech (search) received NMPA approval for IND application of HBM7575/SKB575 (search), a long-acting bispecific antibody targeting TSLP (search) and an undisclosed target for atopic dermatitis (search) treatment.
The investigational therapy features a dual mechanism of action that blocks TSLP (search)-mediated signaling pathways while targeting a second undisclosed antigen to overcome resistance issues associated with single-target TSLP antibodies.
Based on preclinical data, the extended half-life formulation is expected to support dosing intervals of more than three months, potentially offering improved patient convenience and treatment adherence.
Harbour BioMed (search) and Kelun-Biotech (search) announced that China's National Medical Products Administration (search) (NMPA) has approved the Investigational New Drug (IND) application for HBM7575/SKB575 (search), a long-acting bispecific antibody targeting thymic stromal lymphopoietin (search) (TSLP (search)) and an undisclosed target for treating atopic dermatitis (search). The approval enables the companies to proceed with clinical trials for this novel therapeutic approach.
Addressing Significant Unmet Medical Need
Atopic dermatitis (search) represents a substantial global health burden, affecting around 20% of children and up to 10% of adults worldwide. The chronic, inflammatory skin disease is characterized by persistent itching, redness, and irritation, profoundly impacting patients' quality of life through its cyclical pattern of flare-ups and remissions.
Current treatment options, including topical corticosteroids, biologics, and Janus kinase (JAK) inhibitors, provide symptomatic relief for many patients but often fail to deliver sustained disease control, particularly in moderate-to-severe cases. This treatment gap creates an urgent need for safer, more effective, and durable therapies that address underlying disease mechanisms and improve long-term outcomes.
Innovative Dual-Target Mechanism
HBM7575/SKB575 (search) employs a dual mechanism of action designed to overcome limitations of existing therapies. The bispecific antibody blocks the interaction between TSLP (search) and its receptor, inhibiting TSLP-mediated signaling pathways and the activation of Th2 immune cells. Simultaneously, it binds to and blocks an undisclosed target, generating a synergistic effect that addresses resistance issues associated with TSLP single-target antibodies.
"By targeting TSLP (search), a key upstream driver of type 2 inflammation, and an undisclosed target, HBM7575/SKB575 (search) has the potential to be a best-in-class, bispecific antibody for this disease," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed (search).
Extended Dosing Convenience
The investigational therapy has been engineered to possess an extended half-life and favorable developability profile, enabling subcutaneous administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.
"As a bispecific antibody with a differentiated innovative mechanism and a long-acting profile, SKB575/HBM7575 holds the potential to deliver durable and stable disease control while improving patient treatment experience through reduced dosing frequency," stated Dr. Michael Ge, CEO of Kelun-biotech (search).
Strategic Collaboration Framework
Under the collaboration agreement between Harbour BioMed (search) and Kelun-Biotech (search), HBM7575/SKB575 (search) is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.
The NMPA approval marks an important milestone in Kelun-Biotech (search)'s strategic expansion in autoimmune diseases. The company currently has more than 30 ongoing key innovative drug projects, with 4 projects covering 8 indications already approved for marketing, 1 project in the NDA stage, and more than 10 projects in clinical development.