China's NMPA Clears IND for HBM7575/SKB575, a Bispecific Antibody Targeting TSLP in Atopic Dermatitis
Harbour BioMed (HKEX: 02142) and Kelun-Biotech (6990.HK) announced on March 9, 2026, that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for HBM7575/SKB575, a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed second antigen, for the treatment of atopic dermatitis. The IND clearance permits the companies to initiate clinical trials in China. No commercial brand name has been assigned to the molecule. The dual designation reflects a co-development arrangement: HBM7575 is Harbour BioMed's internal identifier, while SKB575 is Kelun-Biotech's.
The NMPA IND approval authorizes first-in-human or early-phase clinical studies of HBM7575/SKB575 in patients with atopic dermatitis. This is not a marketing authorization; no pivotal efficacy or safety data from controlled clinical trials are yet available. According to the collaboration agreement, Kelun-Biotech leads the design, global development, and commercialization of HBM7575/SKB575, with Harbour BioMed participating in investment and development and sharing benefits as agreed. The molecule is engineered for subcutaneous administration, and preclinical half-life data suggest a dosing interval exceeding three months, the companies said.
Because HBM7575/SKB575 is at the IND stage, no clinical trial outcomes have been reported. The drug's mechanism involves dual antagonism: blocking TSLP from binding its receptor to inhibit Th2 cell activation, and simultaneously binding an undisclosed target to generate what the companies describe as a synergistic effect intended to overcome resistance associated with single-target anti-TSLP antibodies. The identity of the second target has not been disclosed. Preclinical data supporting the IND application have not been published in detail. Clinical endpoints typical for atopic dermatitis trials — such as EASI-75 response, IGA 0/1, and Pruritus NRS — would be expected in future studies but are not yet available for this molecule.
Atopic dermatitis affects approximately 20% of children and up to 10% of adults globally, according to the Atopic Dermatitis Atlas. Current treatments include topical corticosteroids, biologics such as dupilumab (Dupixent, Regeneron/Sanofi) and tralokinumab (Adbry, LEO Pharma), JAK inhibitors including upadacitinib (Rinvoq, AbbVie) and abrocitinib (Cibinqo, Pfizer), and more recently approved agents such as nemolizumab (Nemluvio, Galderma) and lebrikizumab (Ebglyss, Eli Lilly). Despite this expanding armamentarium, many patients with moderate-to-severe disease do not achieve sustained control, and the cyclical nature of flare-ups and remissions continues to represent a treatment gap. HBM7575/SKB575 joins a competitive landscape that includes several agents in late-stage development targeting pathways beyond IL-4/IL-13, including amlitelimab (anti-OX40L, Sanofi, Phase 3), rocatinlimab (anti-OX40, Amgen, Phase 3), and tezepelumab (anti-TSLP, Amgen/AstraZeneca, Phase 2 in atopic dermatitis). TSLP-directed therapy has been validated in asthma through tezepelumab's approval as Tezspire, but no anti-TSLP agent has yet been approved for atopic dermatitis, making HBM7575/SKB575's bispecific approach and extended dosing profile features that will require clinical validation in this indication.
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