Announcement of Completion of Enrollment of First Subject in Phase 2/3 Clinical Trial of Pirfenidone for Expanded Indication in Cancer-Related Pulmonary Complications

Overview of the Clinical Trial

Gyre Pharmaceuticals, a consolidated subsidiary of GNI Group, Inc., completed the enrollment of the first subject in the Phase 2/3 clinical trial of pirfenidone capsules (brand name: Iceury) targeting radiation-induced lung injury (RILI) in April 2026. This trial integratively and adaptively assesses safety and efficacy and obtained clinical trial commencement approval from the China National Medical Products Administration in March 2025.

Future Outlook and Impact on Investors

RILI is a serious complication in thoracic tumor patients with limited treatment options. The expanded indication of pirfenidone addresses this unmet medical need. Gyre Pharmaceuticals will continue to advance clinical development aiming to improve patient quality of life. The impact of this clinical trial progress on the Group’s consolidated financial results is considered minimal.