FDA approvals

FDA Approval of Brensocatib Signals New Era for NCFB Treatment: Strategic Implications for China’s Respiratory Pipeline

Insmed’s FDA approval of BRINSUPRI™ (brensocatib) for non-cystic fibrosis bronchiectasis marks a new era for neutrophil-targeted therapies. Originally discovered by AstraZeneca, brensocatib's success could reshape China’s respiratory drug innovation and investment landscape.

SDW Editor

— 4 min read

On August 12, 2025, the U.S. FDA approved Insmed’s BRINSUPRI™ (brensocatib), marking a historic milestone as the first approved therapy for non-cystic fibrosis bronchiectasis (NCFB) and the first dipeptidyl peptidase 1 (DPP1) inhibitor for neutrophil-mediated diseases. Brensocatib is one of the notable approvals in our 2025 FDA approvals analysis (SinoDrugWatch, 2025), highlighting its role in validating DPP1 inhibition as a transformative mechanism for chronic respiratory diseases and positioning China’s biotech sector to capitalize on a burgeoning global market.

This landmark approval is reinforced by Insmed’s official press release on August 12, 2025, confirming BRINSUPRI™ as the “first and only treatment” for NCFB, a serious chronic lung disease (Insmed, 2025).

Clinical and Market Impact

Brensocatib, an oral, once-daily small molecule, targets DPP1 to reduce neutrophil serine protease activity, addressing the chronic airway inflammation driving NCFB progression. The Phase 3 ASPEN trial (NEJM, 2025; DOI: 10.1056/NEJMoa2411664) demonstrated a 21.1% reduction in pulmonary exacerbations for the 10 mg dose (p=0.002) and 19.4% for the 25 mg dose (p=0.006) in 1,719 patients, alongside prolonged time to first exacerbation and reduced lung function decline (FEV1, 25 mg dose). Safety was comparable to placebo, with manageable adverse events like headache and upper respiratory tract infection (AJMC, 2025).

With an estimated 500,000 diagnosed NCFB patients in the U.S. and 1–2 million in China (The Lancet Respiratory Medicine, 2024), brensocatib addresses a significant unmet need. Priced at $88,000 annually, Insmed projects U.S. sales of $3.7 billion by 2031 (FiercePharma, 2025). Pending applications with the EMA, MHRA, and a planned 2025 filing in Japan signal global ambitions, with launches expected in 2026.

Strategic Relevance for China’s Biotech Landscape

While BRINSUPRI™ is a U.S.-led development, brensocatib was originally discovered by AstraZeneca, which licensed it to Insmed in 2016. Its approval amplifies opportunities for China’s respiratory drug pipeline, particularly DPP1 inhibitors. China’s NCFB burden is substantial, driven by post-infectious etiologies and low adoption of evidence-based treatments. The BE-China registry has advanced local research, but no specific NCFB therapies are approved, creating a gap that Chinese biotechs are poised to fill.

Fosun Pharma’s XH-S004, a DPP1 inhibitor for NCFB and COPD, exemplifies this potential. As detailed in our recent analysis (SinoDrugWatch, August 2025), Fosun out-licensed ex-China rights to Expedition Therapeutics for up to $645 million, retaining China rights to leverage its domestic infrastructure. Phase II trials in China show promise, positioning XH-S004 as a fast-follower to brensocatib. Similarly, Haisco Pharmaceutical’s HSK31858, another DPP1 inhibitor, reported positive Phase II results in March 2025 for NCFB, reinforcing China’s growing expertise in this mechanism.

Brensocatib’s approval validates DPP1 inhibition, de-risking investment in China’s pipeline. The global market for neutrophil-mediated respiratory therapies could exceed $1 billion, with oral dosing offering advantages over biologics in patient adherence and cost (SinoDrugWatch, 2025). Chinese firms could accelerate development through partnerships, as seen with Fosun’s deal, or pursue independent global filings, mirroring Dizal Pharmaceutical’s success with sunvozertinib (Zegfrovy) for EGFR exon20ins NSCLC in 2025.

Competitive and Strategic Outlook

Brensocatib’s first-mover advantage sets a high bar, but China’s DPP1 inhibitors could differentiate through formulation, dosing, or regional pricing strategies. Fosun’s XH-S004, with its dual NCFB/COPD focus, targets China’s 100 million-plus COPD population, a larger market than NCFB. Haisco’s HSK31858 may explore combination therapies to enhance efficacy. Both companies benefit from brensocatib’s regulatory precedent, which could streamline China’s NMPA approvals.

For Chinese biotechs, brensocatib’s success underscores the value of early global licensing to share development costs while retaining domestic control. Fosun’s deal with Expedition Therapeutics, backed by Qiming Venture Partners, highlights China’s shift from licensing-in to exporting first-in-class candidates. As Insmed explores Asian markets, partnerships with Chinese firms could expedite BRINSUPRI’s entry, leveraging local expertise and infrastructure.

SinoDrugWatch Take

The FDA approval of brensocatib not only transforms NCFB treatment but also catalyzes China’s respiratory innovation pipeline. Fosun’s XH-S004 and Haisco’s HSK31858 position China to compete in a validated therapeutic class, with potential to address both domestic and global unmet needs. As China’s biotech sector evolves from follow-on to first-in-class innovation, strategic partnerships and regulatory alignment with global precedents will be critical to capturing the $1 billion-plus DPP1 inhibitor market. Brensocatib’s milestone reinforces the urgency for Chinese firms to accelerate clinical and commercial execution in this high-potential space.

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