GYRE News & Events

Gyre Therapeutics announced that the Center for Drug Evaluation, or CDE, of China's National Medical Products Administration, or NMPA, has accepted its new drug application, or NDA, for F351 as a treatment for chronic hepatitis B-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus. The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals. This marks the second major product for which Gyre has submitted an NDA to the NMPA.

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.