The IND approval in China clears the way for clinical development of SKB575/HBM7575, a long-acting bispecific antibody, advancing the collaboration between Kelun-Biotech and Harbour BioMed to address unmet needs in autoimmune diseases such as atopic dermatitis.

Harbour BioMed’s Dr. Jingsong Wang notes the potential for SKB575/HBM7575 to achieve best-in-class status by targeting upstream type 2 inflammation via TSLP and its undisclosed partner, marking progress in the partnership.

The IND milestone aligns with Kelun-Biotech’s expansion into autoimmune diseases and fits Harbour BioMed’s strategy to push next-generation antibody therapies for inflammatory conditions.

Context about Kelun-Biotech’s ADC and DC platforms and Harbour BioMed’s Harbour Mice, HBICE, and HBICATM technologies underscores how the collaboration leverages complementary strengths.

Leaders from both companies, Kelun-Biotech CEO Dr. Michael Ge and Harbour BioMed’s Dr. Jingsong Wang, express optimism that SKB575/HBM7575 could provide durable disease control and a convenient dosing profile for patients.

SKB575/HBM7575 is designed to inhibit TSLP signaling while engaging an undisclosed second target, delivering a dual mechanism of action with an extended half-life intended for dosing intervals of more than three months and subcutaneous administration.

Kelun-Biotech operates as a holding subsidiary focused on innovative biologics and small molecules, with multiple ADC platforms (OptiDC) in development, supporting the collaboration’s drug development pathway.

The collaboration aims for a best-in-class bispecific that disrupts upstream type 2 inflammation via TSLP and the second target, potentially offering safer and longer-lasting control.

Harbour BioMed’s portfolio leverages Harbour Mice, HBICE bispecific antibodies, and HBICATM platforms, with a co-discovery and co-development approach that complements Kelun-Biotech’s broad development program.

Atopic dermatitis is a chronic inflammatory skin disease affecting a large patient population, with current treatments often failing to provide durable control, highlighting the need for safer, longer-lasting therapies.

Under the collaboration, Kelun-Biotech leads global development and commercialization, while Harbour BioMed contributes investment and development support, sharing potential benefits as agreed.

NMPA approval confirms IND clearance for HBM7575/SKB575, enabling a long-acting bispecific antibody trial in atopic dermatitis that targets TSLP and an undisclosed antigen.