GYRE News & Events

Reports Q1 revenue $22.52M, consensus $31.61M. "Building on our successful pre-NDA meeting with China's CDE at the beginning of the year, we are particularly encouraged by the NMPA's priority review designation for F351, reinforcing both the strength of our clinical data and the significant unmet need in liver fibrosis," said Ying Luo, Chief Executive Officer of Gyre Therapeutics. "In parallel, our acquisition of Cullgen expands our capabilities into targeted protein degradation, positioning Gyre to drive long-term innovation beyond fibrosis. We believe these achievements strengthen our foundation as a fully integrated, multi-national biopharmaceutical company as we advance our mission to deliver transformative therapies to patients worldwide."

Gyre Therapeutics announced that the Center for Drug Evaluation of China's National Medical Products Administration, or NMPA, has granted priority review status to the New Drug Application for Hydronidone as a treatment for chronic hepatitis B-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co., plans to submit a formal NDA in the near future.

The company anticipates that 2026 will be a transition period, during which it plans to prioritize regulatory activities, including preparation for the planned NDA submission of Hydronidone. In addition, given uncertainties associated with the National Centralized Drug Procurement program and evolving market dynamics, the company expects to moderate promotional activities for Contiva and Etorel.

Reports Q4 revenue $37.2M, consensus $35.44M. "2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China's CDE," said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. "Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States."