Gyre Therapeutics' NDA for F351 accepted by China's NMPA for CHB-induced liver fibrosis

GYRE THERAPEUTICS, INC.

• NDA for F351 (hydronidone) accepted by CDE of China's NMPA for chronic hepatitis B-induced liver fibrosis.
• NMPA granted priority review status in March 2026; this is Gyre's first NDA for the F351 program.
• If approved, F351 could address tens of millions of HBV patients in China at risk of fibrosis and cirrhosis.
• Dr. Ying Luo noted positive CDE interactions and the potential of F351 as an innovative therapeutic option.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.