F528 / GNI Group - LARVOL DELTA

Gyre Therapeutics Reports Second Quarter 2025 and Year-to-Date Financial Results and Provides Business and Leadership Update (GlobeNewswire) - "Pipeline Development Updates:...F528...is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026."

IND • Chronic Obstructive Pulmonary Disease

Gyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "ETUARY (pirfenidone): Delivered $21.7 million in Q1 sales. While sales declined year-over-year due to relatively high sales in the first quarter of 2024, ETUARY remains the market leader for idiopathic pulmonary fibrosis (IPF) in the PRC. Nintedanib: Gyre remains on track to commercially launch nintedanib in May 2025, targeting multiple forms of fibrosing interstitial lung disease ('ILD'), including IPF, systemic sclerosis-associated ILD, and progressive fibrosing ILD....F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease ('COPD'), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre Pharmaceuticals plans to submit an IND application in 2026."

Launch • Sales • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Systemic Sclerosis

Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Pipeline Development Updates:...(i) F230: F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension ('PAH'), is expected to begin a Phase 1 trial in 2025; (ii) F528: F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease ('COPD'), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026."

IND • New P1 trial • Chronic Obstructive Pulmonary Disease • Pulmonary Arterial Hypertension