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Gyre Therapeutics, Inc.

Pipeline5 assets

  • HydronidoneF351 / TGFβRI/p38γ (anti-fibrotic) / Small molecule / Fibrosis
    CHB-associated liver fibrosisNDA (priority review)NDA submission for conditional approval expected 1H 2026; Breakthrough Therapy designation (NMPA, Mar 2021)ChinaMASH-associated liver fibrosisIND-enablingU.S. IND application anticipated in 2026United States
  • PirfenidoneETUARY / Anti-fibrotic / Small molecule / Fibrosis/Respiratory
    Idiopathic pulmonary fibrosis (IPF)Approved/MarketedApproved in China (2011); commercializedChinaPneumoconiosis (PD)Phase 352-week Phase 3 trial enrollment completed (272 patients, 18 sites)ChinaRadiation-induced lung injury (RILI) with or without immune-related pneumonitisClinicalIn developmentChina
  • F573F573 / Caspase inhibitor / Small molecule / Hepatology
    Acute/acute-on-chronic liver failure (ALF/ACLF)ClinicalIn developmentChina
  • F528F528 / Small molecule / Respiratory
    Chronic obstructive pulmonary disease (COPD)PreclinicalIn developmentChina
  • F230F230 / Small molecule / Cardiopulmonary
    Pulmonary arterial hypertension (PAH)PreclinicalIn developmentChina

Latest news7 items

All news

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026 Completed acquisition of Cullgen in an approximately $300 million

Trial Start • Phase 2/3
Gyre Therapeutics, Inc. • Endpoint Arena