Press release
Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025 Commercial launch in the PRC of generic nintedanib for the treatment of
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025 Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025 Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025 Full year 2025 total revenue guidance of $118 to $128 million SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update. “2025 is shaping up to be a pivotal year for Gyre across both our commercial-stage and clinical-stage portfolios. We plan to expand and enhance our commercial product offerings through the additions of nintedanib for IPF, SSc-ILD and PF-ILD, as well as avatrombopag for CLD-associated thrombocytopenia and chronic idiopathic thrombocytopenia (“ITP”). Given our proven track record and extensive sales and marketing platform, we are confident in our ability to successfully launch and expand these two products in the PRC,” said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. “In parallel, we expect to share topline data from our pivotal Phase 3 trial in CHB-associated liver fibrosis in the second quarter of 2025, which will help inform our U.S. Phase 2 proof-of-concept trial of F351 in MASH-associated liver fibrosis.” Full Year 2024 Business Highlights and Upcoming Milestones Commercial-Stage Updates ETUARY (Pirfenidone) sales update: For the year ended December 31, 2024, Gyre Pharmaceuticals generated $105.0 million primarily in sales of ETUARY.Nintedanib: In May 2024, Gyre Pharmaceuticals executed a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to obtain the drug registration certificate for and became the marketing authorization holder of nintedanib, the other product approved for the treatment of treatment of idiopathic pulmonary fibrosis (“IPF”). In addition, it has also been approved for the treatment of SSc-ILD and PF-ILD. Gyre Pharmaceuticals plans to initiate commercialization of the nintedanib product in the PRC in 2025.Avatrombopag: In June 202...