Gyre Therapeutics Inc（GYRE）資訊與事件GYREGyre Therapeutics Inc

Gyre Therapeutics Files to Sell 30.22M Shares of Common Stock

Gyre Therapeutics files to sell 30.22M shares of common stock for holders

Gyre Therapeutics' F351 NDA Accepted by China's NMPA

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.

Gyre Therapeutics Q1 Revenue $22.52M, Below Consensus

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."