Core Insights - Gyre Therapeutics has completed patient enrollment in a 52-week Phase 3 clinical trial for Pirfenidone capsules aimed at treating pneumoconiosis, a chronic lung disease [1][2] Industry Overview - Pneumoconiosis is the most common and severe occupational disease in China, affecting over 450,000 patients with thousands of new cases annually, caused by long-term inhalation of mineral dusts [3][4] - There is currently no approved therapy in China specifically targeting the fibrotic mechanisms of pneumoconiosis, highlighting a significant unmet medical need [3][4] Clinical Trial Details - The Phase 3 trial involves 272 patients across 18 clinical research centers in China, designed to assess the efficacy and safety of Pirfenidone over a 52-week period [2][5] - The trial compares Pirfenidone at a dosage of 1,800 mg/day with a placebo [5] Drug Information - Pirfenidone, originally approved in China in 2011 for idiopathic pulmonary fibrosis, functions by inhibiting TGF-β signaling and fibroblast proliferation [6] - Gyre is expanding the use of Pirfenidone beyond idiopathic pulmonary fibrosis to include treatment for pneumoconiosis and oncology-related pulmonary complications [6] Trial Objectives and Endpoints - The primary endpoint of the trial is the change in forced vital capacity (FVC) % predicted at Week 52, with key secondary endpoints including changes in lung diffusing capacity, 6-minute walk distance, and rates of acute exacerbations [9]