Press release
Gyre Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC remains on track with data anticipated by early 2025 U.S.
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC remains on track with data anticipated by early 2025 U.S. IND submission to evaluate F351 for the treatment of NASH-associated liver fibrosis expected in late 2024; Phase 2a trial expected to initiate in 2025 Acquired the rights to complementary assets relating to nintedanib through Gyre Pharmaceuticals to improve competitiveness in the PRC Cash and cash equivalents totaled $29.8 million as of March 31, 2024 SAN DIEGO, May 09, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced financial results for the first quarter ended March 31, 2024, and provided a business update. “Supported by sales of our market-leading IPF drug, ETUARY, Gyre is well-positioned to advance multiple pipeline programs addressing organ fibrosis, including our Phase 3 clinical trial of F351 in CHB-associated liver fibrosis in the PRC that is on track to report data by early 2025,” said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. “Pending these results, we plan to initiate a Phase 2a trial in the U.S. for F351 in patients with NASH-associated liver fibrosis with the goal of obtaining early proof-of-concept as a basis of expansion into a more comprehensive Phase 2/3 clinical program. We look forward to continuing to grow the company, accelerate our clinical development programs, and strengthen our research and development efforts to bring medicines for fibrotic and inflammatory conditions to patients in need.” First Quarter 2024 Business Highlights and Upcoming Milestones ETUARY (Pirfenidone capsules) Sales Update Generated sales of $26.9 million in Q1 of 2024. For the quarter ended March 31, 2024, Beijing Continent Pharmaceuticals Co., Ltd. (d/b/a Gyre Pharmaceuticals), Gyre’s majority indirectly owned subsidiary in the People's Republic of China (“PRC”), generated $26.9 million in sales of ETUARY, representing an increase of 10% from the same period in 2023, driven by enhanced marketing and sales initiatives in regions of the PRC where sales were previously lower in the first quarter of fiscal year 2023. Clinical Development Updates F351 (Hydronidone): Phase 3 trial evaluating...