World's First DPP1 Inhibitor Approved, Creating a New Hotspot in Respiratory Disease Treatment
On August 12, 2025, Insmed announced that the FDA formally approved its DPP1 inhibitor brensocatib for marketing for the treatment of non-cystic fibrosis bronchiectasis in children aged 12 years and above and adults.
On August 12, 2025, Insmed announced that its DPP1 inhibitor, brensocatib, received FDA approval for the treatment of non-cystic fibrosis bronchiectasis in patients aged 12 years and older. This marks the arrival of the first targeted drug for this disease, filling a long-standing treatment gap. As an oral, selective DPP1 inhibitor, brensocatib inhibits DPP-1, preventing neutrophil serine protease activation and thereby suppressing the associated inflammatory response. Its approval was based on results from the Phase III ASPEN trial, which followed over 1,680 patients for 48 weeks. Data showed that over 52 weeks, the annualized rate of lung exacerbations in the 10mg and 25mg dose groups decreased by 21.1% and 19.4%, respectively, compared to the placebo group, and was well tolerated.
Domestic pharmaceutical companies are also accelerating their development of DPP1 targets. Fosun Pharma recently licensed the overseas rights to its oral DPP1 inhibitor XH-S004 to US-based Expedition Pharmaceuticals for US$645 million. The drug is currently in Phase II clinical trials for bronchiectasis and Phase Ib clinical trials for COPD in China. Haisco's HSK31858 has entered Phase III clinical trials for bronchiectasis and has been approved for COPD. Hengrui Pharma's related inhibitor is in Phase Ib, targeting COPD and other inflammatory diseases.
The approval of brensocatib not only provides a new option for patients with non-cystic fibrosis bronchiectasis but also establishes DPP1 as a new treatment option for respiratory diseases. With continued R&D efforts by domestic and international companies, more treatment options for this target are expected to emerge, bringing benefits to patients with neutrophil-mediated inflammatory diseases and injecting new growth momentum into the industry.