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Gyre Therapeutics (GYRE) investor relations material

Gyre Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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H.C. Wainwright 27th Annual Global Investment Conference summary10 Sep, 2025

Company Overview and Market Position

  • Maintains over 90% market share in pirfenidone and 50% in IPF in China, treating over 150,000 patients and covering more than 3,000 hospitals and pharmacies.

  • Achieved EBITDA positivity since 2017, with a 32% CAGR and revenue reaching $105.8M in 2024.

  • Employs about 600 people globally and operates two GMP-certified manufacturing facilities in China.

  • Drug pricing in China is significantly lower than in the U.S., prompting plans for U.S. market entry.

  • Expanded IPF franchise by acquiring generic nintedanib and Contiva (avatrombopag) to strengthen the liver disease network.

Pipeline and Clinical Development

  • Hydronidone (F351) is a next-generation fibrosis therapy, showing significant Phase 3 results for CHB with fibrosis regression and inflammation improvement at 52 weeks.

  • Plans to file for NDA in China in Q3 2025 and IND in the U.S. for advanced fibrosis, focusing on late-stage (F3-F4) patients.

  • Pipeline includes F573 for ALF/ACLF (Phase 2), F528 for COPD (Phase 1), and indications in radiation-induced lung injury and pneumoconiosis.

  • Hydronidone’s mechanism targets TGF-β/p38y/Smad7 signaling, offering a differentiated approach from current standards.

  • Recently acquired rights to Contiva/Evotrauma PEG to expand treatment offerings.

Clinical Results and Regulatory Progress

  • Hydronidone Phase 3 for CHB met primary and secondary endpoints with strong statistical significance and favorable safety profile, including lower serious adverse events and no discontinuations due to adverse events.

  • Received breakthrough designation in China and plans to seek accelerated approval.

  • Preclinical and clinical data show enhanced potency and reduced hepatotoxicity compared to pirfenidone.

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Q3 202513 Nov, 2025
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Frequently asked questions

Gyre Therapeutics Inc., formerly known as Catalyst Biosciences, Inc., is a biopharmaceutical company engaged in the development and commercialization of therapies for organ fibrosis and inflammatory diseases. The company's main focus is on the development of Hydronidone (F351), a therapeutic aimed at treating Metabolic Dysfunction Associated Steatohepatitis (MASH-associated liver fibrosis), previously known as Nonalcoholic Steatohepatitis (NASH). The company is headquartered in San Diego, California, and its shares are listed on the NASDAQ.

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