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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.
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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