Gyre Therapeutics (GYRE) Corporate presentation summary

Business overview and market position

• Holds leading IPF market share in China for 10 consecutive years, treating over 150,000 patients with pirfenidone and covering 3,000+ hospitals and pharmacies across 870+ cities.

• Achieved EBITDA positivity since 2017 with revenue growing at a 32% CAGR; 2023 revenue was $113.5M and 2024 revenue was $105.8M.

• Expanded IPF franchise by acquiring generic Etorel (nintedanib) and Contiva (avatrombopag) to strengthen presence in lung and liver disease markets.

• Operates two GMP-compliant manufacturing facilities in China, currently running at 40% and 18% capacity.

Pipeline and clinical development

• Lead asset Hydronidone (F351) targets advanced liver fibrosis and CHB-related liver fibrosis, with positive Phase 3 results showing significant fibrosis regression and inflammation improvement.

• Pipeline includes F573 for acute liver failure, F528 for COPD, and ETUARY (pirfenidone) for IPF and other lung indications.

• Hydronidone received Breakthrough Therapy Designation in China; NDA submission expected Q3 2025, with U.S. IND filing for advanced fibrosis planned in 2025.

• China-first validation strategy leverages faster enrollment and cost efficiency, followed by U.S. expansion.

Scientific and clinical differentiation

• Hydronidone is a structural analog of pirfenidone, designed for enhanced potency and safety by targeting TGF-β/p38γ/Smad7 pathways.

• Demonstrated higher p38γ inhibition and upregulation of Smad7, resulting in improved anti-fibrotic efficacy and reduced hepatotoxicity compared to pirfenidone.

• Animal studies confirm upregulation of Smad7 and inhibition of Smad2/3 phosphorylation, supporting clinical potential.

• Hydronidone's Phase II metabolism offers a safer hepatic profile, with no discontinuations due to adverse events in trials.