GYRE · Gyre Therapeutics, Inc.

Gyre Therapeutics' announcement of NMPA acceptance for the F351 NDA represents a critical regulatory milestone, advancing the company's lead pipeline candidate toward potential approval in China for chronic hepatitis B-induced liver fibrosis, a condition affecting tens of millions of HBV patients. The prior priority review designation, granted after NDA submission through majority-owned subsidiary Gyre Pharmaceuticals (69.7% equity interest as of March 31, 2026), signals accelerated review with additional resources, potentially expediting commercialization. F351, a modified pirfenidone derivative targeting TGF-β1 pathway, demonstrated statistically significant fibrosis regression in a pivotal Phase 3 trial after 52 weeks, building on the company's established expertise with ETUARY™ (pirfenidone) for IPF. CEO Dr. Ying Luo highlighted positive CDE interactions and F351's potential as an innovative therapy where no non-viral directed treatments exist for HBV fibrosis. In the US, completed Phase 1 supports planned IND by end-2026 and Phase 2 initiation, expanding F351's dual-indication strategy to MASH fibrosis. This progress de-risks the fibrosis franchise, enhances Gyre's pipeline value, and positions it to address high-unmet needs in organ fibrosis.