Insmed’s Small-Molecule Therapy Brinsupri Receives FDA Approval for NCFB
Source: Dengyuemed | August 15, 2025 | Category: NCFB
On August 13, 2025, the pharmaceutical sector rose by +1.73%, outperforming the CSI 300 Index by 0.94 percentage points, ranking 4th among Shenwan’s 31 sub-sectors. Leading sub-sectors included Medical R&D Outsourcing (+5.93%), Other Biologics (+2.28%), and Vaccines (+1.71%), while Offline Pharmacies (-0.26%), Blood Products (-0.08%), and Medical Devices (+0.09%) lagged.
Top gainers of the day were Shouyao Holdings (+19.99%), Sino Medical (+17.48%), and Olin Biotechnology (+17.17%); top decliners were Sanxin Medical (-4.84%), Mapu Medical (-3.93%), and Chenxin Pharmaceuticals (-3.67%).
Industry News
Insmed announced that the U.S. FDA has approved its once-daily, oral first-in-class therapy Brinsupri (Brensocatib, 10 mg and 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults and children aged 12 years and older.
Brinsupri is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor designed to block activation of key neutrophil-driven enzymes responsible for chronic airway inflammation in NCFB.
This marks the first FDA-approved therapy for NCFB.
Marketing authorization applications have also been accepted by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
(Source: Insmed, Pacific Securities Research Institute)
Corporate Updates
- North China Pharmaceutical (600812): Reported H1 2025 revenue of RMB 5.275 billion (+0.84% YoY), net profit attributable to shareholders of RMB 123 million (+71.56% YoY), and non-recurring net profit of RMB 120 million (+120.69% YoY).
- RemeGen Biotech (688331): Announced its self-developed BLyS/APRIL dual-target fusion protein Telitacicept (RC18) for primary Sjögren’s syndrome met the primary endpoint in a Phase III clinical trial.
- Zhixiang Jintai (688443): Completed an EOP2 meeting with the CDE for a Phase III trial evaluating GR1802 injection for seasonal allergic rhinitis; trial initiation is planned.
- Pumen Technology (688389): Received regulatory approval for its cardiac biomarker quality control product, enhancing competitiveness and market expansion.
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