GNI Group Ltd. [2160.T]

TOKYO, Apr 20 (Pulse News Wire) – GNI Group Ltd. (2160.T) announced today that its subsidiary, Gyre Pharmaceuticals Co., Ltd., completed the enrollment of the first patient in a Phase 2/3 clinical trial evaluating pirfenidone capsules (trade name: Aisuryu) for radiation-induced lung injury (RILI).

The trial, which began in March 2025 after receiving approval from China's National Medical Products Administration (NMPA), aims to assess the safety and efficacy of pirfenidone in treating RILI, regardless of whether patients also suffer from immune checkpoint inhibitor-related pneumonia (CIP). Pirfenidone is one of the few low-molecular-weight drugs globally approved for idiopathic pulmonary fibrosis (IPF). It possesses broad anti-inflammatory, antioxidant, and antifibrotic properties.

Gyre Pharmaceuticals seeks to expand the drug’s application to RILI based on its proven effectiveness in IPF treatment. The ongoing trial will further evaluate pirfenidone's safety and efficacy in RILI patients. GNI Group stated that while the impact of this clinical development on the group's consolidated performance is expected to be minor, the company remains committed to advancing clinical research to offer improved therapeutic options for patients with unmet medical needs.

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