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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 Appoints Three New Members to its Board of Directors

SAN DIEGO, July 16, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that its Board of Directors has appointed

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