A Twice-Yearly Shot to Change COPD Treatment: Inside the High-Stakes Race

CAMBRIDGE, Mass. – June 09, 2026 – In the world of biopharmaceutical innovation, the distance between a promising molecule and a life-changing therapy is measured in clinical trials, strategic partnerships, and billions of dollars. This week, a significant step was taken on that journey as Harbour BioMed's partner, Windward Bio, announced it has dosed the first patients in a Phase 2 study for a potential new treatment for Chronic Obstructive Pulmonary Disease (COPD). While the start of a mid-stage trial is standard industry news, the drug at its center—HBM9378/WIN378—is anything but. It represents a potential paradigm shift: a subcutaneous injection administered just twice a year to manage a relentless respiratory disease.

The initiation of the SIRIUS study, as it is called, does more than just expand the drug’s development from asthma into a second major respiratory illness. It thrusts a complex web of international biotech players into the heart of a fiercely competitive race to redefine respiratory care, targeting a multi-billion dollar market and offering a new horizon of hope for millions of patients.

The Unseen Burden of COPD

To understand the significance of a twice-yearly shot, one must first grasp the daily reality of living with COPD. Far more than a 'smoker's cough,' COPD is a progressive, irreversible lung disease and the third leading cause of death worldwide. It makes breathing a constant struggle, turning simple activities like walking up stairs or carrying groceries into monumental challenges. The disease is characterized by immune-mediated airway inflammation and persistent airflow obstruction, but its most devastating feature is exacerbations—sudden, severe flare-ups that often result in emergency room visits, hospitalizations, and a permanent, downward step in lung function.

Despite a range of available inhaled therapies, the press release notes that more than three million patients with moderate-to-severe COPD remain at high risk of these recurrent exacerbations. Current treatments, which often require daily, and sometimes multiple daily, inhaler use, focus on managing symptoms but fall short of addressing the underlying inflammatory drivers for many. This treatment gap creates a profound unmet need for therapies that can not only offer better control but also simplify the treatment burden, improving adherence and quality of life.

A New Strategy: Targeting the TSLP Pathway

The scientific community has zeroed in on a key culprit in the inflammatory cascade of respiratory diseases: Thymic Stromal Lymphopoietin, or TSLP. Often described as an 'alarm bell' cytokine, TSLP is released at the top of the inflammatory pathway in response to triggers like viruses, allergens, and pollutants, setting off a chain reaction that leads to the airway inflammation seen in both asthma and COPD.

Blocking TSLP is not a new idea. The groundbreaking approval of Tezspire (tezepelumab) from Amgen and AstraZeneca in 2021 proved the concept. Tezspire became the first anti-TSLP antibody on the market, offering a powerful new option for severe asthma and generating over half a billion dollars in sales in 2023. However, it comes with a monthly injection schedule. This is where HBM9378/WIN378 aims to rewrite the script.

Developed using Harbour BioMed's proprietary Harbour Mice® platform, which generates fully human antibodies, HBM9378/WIN378 is a next-generation antibody engineered for an exceptionally long half-life. Phase 1 data confirmed it was suitable for twice-yearly dosing, a dramatic leap in convenience that could be a game-changer for patient adherence and preference. By targeting the same validated pathway as the market leader but offering a vastly superior dosing schedule, the drug embodies a 'best-in-disease' ambition.

The Competitive Race for Respiratory Dominance

Harbour BioMed and its partners are not entering an empty field. The success of Tezspire has ignited a fierce race to develop and commercialize TSLP-targeting therapies. While Tezspire has established a strong foothold in asthma, its journey into COPD has been more complex, failing to meet its primary endpoint in a broad patient population but showing promise in a subgroup with specific inflammatory markers. This creates a critical window of opportunity for a new agent that can demonstrate broad efficacy in COPD.

Several other major players are also in the running. Sanofi is advancing lunsekimig, an innovative bispecific antibody targeting both TSLP and IL-13, while smaller biotechs like Uniquity Bio and Upstream Bio are developing their own novel TSLP inhibitors with unique properties. The space is becoming a crowded and well-funded battleground for what could be the next blockbuster class in respiratory medicine.

For HBM9378/WIN378, the strategy is clear: leverage its ultra long-acting profile as a key differentiator. The concurrent development in asthma (the Phase 2/3 POLARIS study) and COPD (the Phase 2 SIRIUS study) is a bold move to establish the drug as a foundational therapy across the spectrum of TSLP-mediated respiratory diseases, with initial asthma data and a Phase 3 start both slated for the second half of 2026.

The Harbour BioMed Blueprint: Innovation Through Partnership

Beyond the science, the story of HBM9378/WIN378 is a masterclass in modern biotech strategy. The molecule's journey highlights a global, multi-company collaboration designed to maximize value and share risk. Originally developed by Harbour BioMed and co-developed with Kelun-Biotech, the global rights (outside of Greater China) were licensed to Windward Bio in a deal reportedly worth up to $1 billion.

This structure allows each company to play to its strengths. Harbour BioMed, with its advanced antibody generation platforms like Harbour Mice® and AI-driven discovery tools, focuses on innovation and creating high-potential assets. Windward Bio, a clinical-stage company with deep development expertise, is tasked with executing the costly and complex late-stage trials needed for global approval. For Harbour BioMed, which is also an investor in Windward Bio, the strategy provides significant non-dilutive funding and validates its technology platform while retaining a stake in the drug's ultimate success.

"This milestone further highlights the potential of HBM9378/WIN378 as a differentiated, ultra long-acting anti-TSLP antibody for immunological diseases," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, in the press statement. "We strongly believe in the potential of HBM9378/WIN378 and Windward Bio's execution capabilities."

As the first COPD patients receive their doses, the industry watches closely. The outcome of the SIRIUS and POLARIS trials will not only determine the fate of a promising drug but also serve as a crucial test of a business model built on technological innovation and strategic syndication. For the millions struggling for breath, the hope is that this complex interplay of science and finance delivers on its simple, profound promise: a better, easier way to breathe.