The "finish line" for COPD biologics in 2025 has been redrawn once again -
Last September, Roche's Astegolimab suffered an unexpected setback in the Phase 3 ARNASA study, instantly turning the IL-33 track from a "four-horse race" into a "three-way battle";
Sanofi/Regeneron's Itepekimab, after releasing the combined analysis of AERIFY-1/-2 in March 2025, has taken the lead in submitting a marketing application to the FDA;
Meanwhile, AstraZeneca's Tozorakimab (IL-33 monoclonal antibody) and GlaxoSmithKline/Johnson & Johnson's Nipocalimab (IL-33 monoclonal antibody) have successively entered Phase III, and the "hunting race" among the three around the same signaling axis has officially begun.
Now, the hunting race for IL-33 among the world's four major pharmaceutical giants has entered the "final lap":
Who can truly cross the finish line in the $30 billion COPD biopharmaceutical market?
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Source: DOI: 10.1183/16000617.0144-2022.
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Mechanism: IL-33 is located at the uppermost stream of the Type 2 inflammatory cascade. Once released, it drives multiple pathways such as IL-4/IL-13, IL-5, and TSLP, and can simultaneously activate eosinophils/basophils/mast cells/ILC2 cells - which exactly correspond to the two unmet populations of COPD: "eosinophilic inflammation subtype" and "overlapping asthma-COPD".
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Population: Patients screened based on blood eosinophils ≥ 300/μL or FeNO ≥ 25 ppb account for approximately 30% of all COPD cases, about 150 million people worldwide, with no approved biologics currently available.
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Competitive Landscape: Compared with IL-4Rα (Dupixent has been approved for COPD first), IL-33 can theoretically cover a broader range of inflammatory phenotypes; compared with the IL-5 pathway (only eosinophilic type), IL-33 has the advantage of "blocking multiple pathways in a package".
Note: Nipocalimab was originally developed by Johnson & Johnson, and GSK obtained global co-development and commercialization rights with a $1.5 billion down payment in September 2024.
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Population Definition
- Sanofi focuses only on "post-smoking cessation" population, AstraZeneca includes "current smokers", and GlaxoSmithKline targets the "overlapping phenotype". Whoever can lower the biomarker thresholds (blood eosinophils/FeNO) to the minimum will capture the largest market.
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Combination Strategy
- The standard treatment for COPD has long been based on LAMA/LABA/ICS "triple therapy". IL-33 monoclonal antibodies must answer: "Does adding an injection on top of triple therapy still significantly reduce acute exacerbations?" AstraZeneca has demonstrated the additive effect of Tozorakimab + Tezepelumab in Phase II, while GSK plans to explore fixed-device combinations with Trelegy Ellipta.
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Safety and Affordability
- COPD patients are older with multiple comorbidities and are extremely sensitive to infection risks. Itepekimab has currently been exposed for >1000 patient-years, with a severe infection rate comparable to that of the placebo; the Phase II data of 300 cases of Tozorakimab also showed no signals. However, all three companies have to face the compliance battle between "subcutaneous injection once every 4-8 weeks" and "daily inhalation".
3S Bio's SSGJ-621 (IL-33R monoclonal antibody) submitted an IND in China in April 2025, planning to directly conduct a global synchronized Phase III; Maiwei Biotech's 9MW1911 (IL-33R monoclonal antibody) chose to first conduct Phase II for asthma and then extrapolate to COPD. Compared with the three overseas giants, local enterprises have the following advantages:
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Can rely on China's huge undiagnosed population for rapid enrollment;
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With a low-cost structure, if it enters medical insurance in the future, the annual treatment cost is expected to be pressed down to $10,000 - $15,000, far lower than the pricing in Europe and the United States.
Conclusion: The "Prisoner's Dilemma" Before the Finish Line
Sanofi holds a priority review voucher, AstraZeneca bets on a broader population + combination strategy, GSK/Johnson & Johnson uses real-world data and device innovation to overtake on a curve, and where will Astegolimab, this "second-hand bullet", end up.
In the $30 billion "gold mine" of COPD, who crosses the finish line first depends not only on clinical data but also on who can piece together the most complex inflammatory puzzle into the "one-injection solution" that patients can easily understand. In the two winters of 2026-2027, the answer will be revealed. The real finishers may be more than one - but the first to cross the line must have the most solid population labeling.
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This article is reviewed and published by the technical expert team of UA
Disclaimer: This article partially utilizes artificial intelligence assistance in its creation. If any content involves copyright or intellectual property issues, please let us know and we promise to verify and remove it as soon as possible.
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