GNI subsidiary completes patient enrollment for pneumoconiosis drug trial

GNI Group Ltd. announced its subsidiary, Gyre Therapeutics, Inc., has completed subject enrollment for the Phase 3 clinical trial of its new drug "Pirfenidone Capsule" (Etuary) for treating pneumoconiosis. The trial, conducted across 18 clinical research centers in China, enrolled a total of 272 patients.

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 52 weeks of Pirfenidone capsule treatment. Pneumoconiosis is a chronic occupational lung disease characterized by progressive pulmonary fibrosis, affecting over 450,000 patients in China with thousands of new cases annually. Experts highlight the substantial unmet medical need for treatments.

The Phase 3 trial will compare Pirfenidone 1,800 mg/day (600 mg three times daily) against a placebo over a 52-week double-blind treatment period. The primary endpoint is the change from baseline in forced vital capacity (FVC) at 52 weeks. GNI Group expects the impact of this development on its consolidated financial results for the current fiscal year to be immaterial.