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- The initiation of this COPD study marks the expansion of HBM9378/WIN378 (also known as SKB378) development into a second major category of respiratory disease.
- HBM9378/WIN378 is currently being evaluated in the Phase II/III POLARIS study for asthma, with preliminary Phase II data expected to be announced in the second half of 2026.
- HBM9378/WIN378 has the potential to become the first ultra-long-acting anti-TSLP antibody approved for both asthma and COPD, with a Phase III study for asthma planned to initiate in the fourth quarter of 2026.
Shanghai, China; Cambridge, Massachusetts, USA; and Rotterdam, NetherlandsJune 9, 2026 /PRNewswire/ — Harbour BioMed (stock code: 02142.HK), a global biopharmaceutical company dedicated to the discovery and development of innovative antibody therapies for immune diseases, oncology, and other areas, today announced that its partner Windward Bio has completed first patient dosing in the Phase II SIRIUS study of HBM9378/WIN378 (also known as SKB378) for the treatment of chronic obstructive pulmonary disease (COPD).
COPD is a progressive, irreversible lung disease and the third leading cause of death worldwide. The disease is rooted in immune-mediated airway inflammation and persistent airflow obstruction, making even daily activities challenging for patients. A core feature of COPD is “acute exacerbations,” sudden and severe worsening of symptoms that often require emergency care or hospitalization and can lead to permanent lung function decline. Despite existing inhaled corticosteroid therapies, over 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, underscoring the urgent need for more effective treatment options.
SIRIUS is a global Phase II randomized, double-blind, placebo-controlled, dose-ranging study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HBM9378/WIN378 in patients with moderate-to-severe COPD.
Dr. Wang Jinsong, Founder, Chairman, and CEO of Harbour BioMed, stated: “We are very pleased to see our partner Windward Bio initiate the Phase II SIRIUS study of HBM9378/WIN378 for COPD, advancing the clinical development of this product. This milestone further highlights the therapeutic potential of HBM9378/WIN378 as a differentiated, ultra-long-acting anti-TSLP antibody in immune diseases. Harbour BioMed is one of the original discoverers of this promising molecule and an investor in Windward Bio’s latest financing round. We firmly believe in the therapeutic potential of HBM9378/WIN378 and the execution capabilities of Windward Bio, and we look forward to continuing to support the program’s progress, ultimately bringing innovative treatment options to COPD patients worldwide.”
About HBM9378/WIN378
HBM9378/WIN378 (also known as SKB378) is a next-generation, fully human monoclonal antibody that potently inhibits the TSLP ligand. TSLP is a clinically validated target that plays a key role in the onset and progression of various immune diseases, including asthma and COPD. HBM9378/WIN378 has been engineered with extended half-life and silenced effector function. Phase I clinical studies have confirmed that HBM9378/WIN378 has a significantly prolonged half-life, enabling dosing every six months; a low incidence of anti-drug antibodies; and a favorable safety and tolerability profile at the highest doses tested. The drug is administered via subcutaneous injection. Currently, Windward Bio has obtained rights from Harbour BioMed (internal code: HBM9378) and Kelun-Biotech (internal code: SKB378) for WIN378 globally, excluding Greater China and certain Southeast Asian and West Asian countries. In clinical development, HBM9378/WIN378 is being evaluated in the Phase II/III POLARIS study for asthma, with preliminary data expected in the second half of 2026; the Phase II SIRIUS study for COPD is also ongoing. Additionally, the first Phase III study of HBM9378/WIN378 for asthma is expected to initiate in the fourth quarter of 2026.
About Harbour BioMed
Harbour BioMed (stock code: 02142.HK) is a global biopharmaceutical company focused on the research and development of innovative drugs for immune diseases, oncology, and other areas. The company rapidly expands its innovative drug pipeline through proprietary research, joint development, and diversified international collaborations.
Harbour BioMed’s proprietary antibody technology platform, Harbour Mice®, can generate fully human monoclonal antibodies in both classical (H2L2) and heavy-chain-only (HCAb) formats. The HBICE® immune cell engagers developed based on the HCAb platform can achieve anti-tumor efficacy unattainable with traditional combination therapies. Meanwhile, the HCAb PLUSTM technology, also derived from the HCAb platform, provides comprehensive new molecular solutions for the development of innovative multispecific drugs across different disease areas. Furthermore, leveraging the Harbour Mice® platform, Harbour BioMed has launched its first fully human AI HCAb model—the fully human HCAb generation and screening model—driven by its Hu-mAtrIxTM artificial intelligence (AI) platform, accelerating the development of innovative therapies.
Harbour Mice®, HBICE®, HCAb PLUSTM, the single B-cell cloning screening platform, and AI technology together form Harbour’s next-generation engine for innovative therapeutic antibody discovery. For more information, please visit: www.harbourbiomed.com.
About Windward Bio
Windward Bio is a clinical-stage biotechnology company with deep expertise in the discovery, development, and commercialization of innovative therapies, dedicated to transforming the treatment landscape for patients with severe immune diseases. Its core pipeline product, WIN378, is a best-in-class potential ultra-long-acting anti-TSLP monoclonal antibody, currently in Phase 2/3 clinical trials for asthma and Phase II studies for COPD. The company’s pipeline also includes WIN027, a clinical-stage long-acting bispecific antibody targeting TSLP×IL-13, with broad therapeutic potential in multiple immune diseases, currently in Phase I clinical trials. Additionally, the company is actively building an early-stage discovery pipeline of long-acting bispecific antibodies based on well-validated biological mechanisms in respiratory and dermatological diseases.