GYRE THERAPEUTICS, INC. 8K

Gyre Therapeutics filed an 8-K to furnish an investor presentation describing its China-focused commercial and R&D strategy, revenue outlook for ETUARY™, NDA status and launch timing for F351, and development plans for its targeted protein degrader and DAC pipeline programs.

Gyre Therapeutics, Inc. furnished an investor presentation as Exhibit 99.1 to its Form 8-K outlining its global, China‑enabled discovery and commercialization model, revenue guidance for its marketed pirfenidone product ETUARY™ in China and the anticipated launch of hydronidone (F351) following acceptance of its NDA for CHB‑associated liver fibrosis by the China NMPA in May 2026, as well as detailed development timelines and preclinical/early clinical data for its targeted protein degrader and Degrader Antibody-Conjugate (DAC) pipeline programs (including CG923308, CG620953, CG001419 and CG009301) and associated forward‑looking statements about future milestones, regulatory decisions and market opportunities.

Filing Facts

CIK

1124105

Ticker

GYRE

Form

8K

Source Type

fda

Accession

0001140361-26-034401

Alert Tier

5