Company Overview - Gyre Therapeutics is a pioneering fibrosis treatment company with a track record of success, including being the first to receive IPF treatment approval (pirfenidone) in China in 2011[7] - The company has maintained a leading IPF market share in China for 10 consecutive years, with approximately 50% overall market share and over 90% share in pirfenidone in 2024[7] - Gyre Therapeutics has approximately 600 dedicated global employees, including around 400 in commercial teams across China and the U S and about 70 focused on R&D[7] - In 2024, Gyre Therapeutics achieved revenue of $105 8 million[8] Hydronidone (F351) Development - Hydronidone (F351) is Gyre's lead asset with the potential to be a first-in-class therapy for CHB-related liver fibrosis, addressing a significant unmet medical need in China, and is expected to initiate a Phase 2 trial in the U S for the treatment of MASH-associated liver fibrosis[11] - In a Phase 2 trial, Hydronidone demonstrated significant fibrosis improvement, with 54 8% of patients in the combined Hydronidone groups showing ≥1 stage fibrosis improvement at Week 52, compared to 25 6% in the placebo group[17] - The U S MASH fibrosis market is estimated to be 7 2 times larger than the CHB fibrosis market[24] Strategic Acquisitions and Future Outlook - Gyre acquired Nintedanib and Avatrombopag in 2024 to strengthen its pirfenidone franchise and prepare for the potential future launch of Hydronidone[45] - The company forecasts 2025 sales of $118 million to $128 million[45] - Gyre expects to submit a New Drug Application (NDA) for Hydronidone in Q2 2025, with NMPA approval anticipated in 2026[53]
Gyre Therapeutics (GYRE) Earnings Call Presentation