Kelun-Biotech Partner Windward Bio Announces First Patients Dosed in Phase 2 SIRIUS COPD Study of SKB378/WIN378

COPD study initiation expands SKB378/WIN378 development into a second major respiratory disease SKB378/WIN378 is currently being evaluated in the Phase 2/3 POLARIS asthma study, with initial Phase 2 data expected in the second half of 2026 SKB378/WIN378 has the potential to be the first-to-market, ultra long-acting anti-TSLP antibody for asthma and COPD, with Phase 3 initiation in asthma planned for Q4 2026 CHENGDU, China , June 9, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") today announced that  its partner Windward Bio has dosed the first patients in the Phase 2 SIRIUS study of SKB378/WIN378 (also known as HBM9378) in patients with chronic obstructive pulmonary disease (COPD). COPD is a progressive, irreversible lung disease and the third leading cause of death worldwide. Driven by immune-mediated airway inflammation and persistent airflow obstruction, the disease makes even routine daily activities a struggle. Its defining feature is exacerbations — sudden, severe flare-ups that lead to emergency room visits, hospitalizations, and lasting declines in lung function. Despite currently available inhaled background therapies, more than 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, underscoring an urgent need for better treatment options. SIRIUS is a global, Phase 2 randomized, double-blind, placebo-controlled, dose-finding study. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKB378/WIN378 in patients with moderate-to-severe COPD. SKB378/WIN378 started as a co-development project jointly conducted by the Company and Harbour BioMed, with both parties equally sharing global rights. About SKB378/WIN378 (also known as HBM9378) SKB378/WIN378 is a next-generation, fully human monoclonal antibody that potently inhibits the TSLP ligand. This clinically validated target plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. SKB378/WIN378 has been engineered to achieve half-life extension (HLE) and silenced effector function . It has been studied in a Phase 1 trial, which confirmed an extended half-life suitable for twice-yearly dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest dose tested. SKB378/WIN378 is administered subcutaneously. Windward Bio licensed the global rights (excluding Greater China and several Southeast and West Asian countries) for SKB378/WIN378 from Kelun-Biotech and Harbour BioMed (also known as HBM9378). WIN378 is currently being evaluated in the POLARIS Phase 2/3 asthma study with initial readouts expected in the second half of 2026. WIN378 is also being evaluated in the SIRIUS Phase 2 COPD study. The first Phase 3 study of WIN378 in asthma is expected to begin in the fourth quarter of 2026. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/ . About Windward Bio Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with serious immunological conditions. Its lead program is WIN378, a potential best-in-disease, ultra long-acting anti-TSLP monoclonal antibody currently in a Phase 2/3 trial for asthma and in a Phase 2 study for COPD. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific with broad therapeutic potential across immunological diseases, which is currently in Phase 1. The company is building a discovery pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions. SOURCE Kelun-Biotech 21 % more press release views with Request a Demo × Modal title Also from this source Multiple Sacituzumab Tirumotecan (sac-TMT) Studies Selected as LBAs at ESMO 2026, OptiTROP-Lung04 and OptiTROP-Lung06 to be Presented in the Lung Cancer Session The 2026 European Society for Medical Oncology (ESMO) Congress will be held in Madrid, Spain, from October 23 to 27. Multiple Phase III clinical... Results from Phase III Study of Trastuzumab Botidotin versus T-DM1 in HER2-Positive Breast Cancer Published in JCO Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or "the Company", 6990.HK) announced that results from the phase III... More Releases From This Source Explore Health Care & Hospitals Biotechnology Medical Pharmaceuticals Clinical Trials & Medical Discoveries News Releases in Similar Topics

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