GNI Group Ltd.
Questions from Investors and Our Company’s Responses
The acquisition of Gyre Pharmaceuticals shares is planned to be completed by the end of December 2026, with full-year earnings guidance revisions handled cautiously in light of year-end external environmental changes. The conditional approval application for F351 in China is scheduled for the first half of 2026.
Key Figures
- Scheduled Timing for Acquisition of Gyre Pharmaceuticals Shares: Planned by the end of December 2026
- Scheduled Conditional Approval Application for F351 in China: First half of 2026
- Cash Outflow Associated with Pulmatrix Share Acquisition: None
AI要約
Summary of Investor Questions and Our Responses
The Company plans to complete the acquisition of Gyre Pharmaceuticals shares, based on the overseas fundraise in July 2025, by the end of December 2026, but intends to remain flexible depending on circumstances. Revisions to full-year earnings guidance will be approached cautiously, taking into account year-end changes in the external environment and impacts from accounting evaluation processes, while continuing transparent disclosure. Regarding the new drug approval application for F351 in China, an agreement has been reached with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and a conditional approval application is planned for the first half of 2026.
Business Progress and Future Outlook
Details of the joint development with Astellas Pharma in Cullgen’s drug discovery business remain undisclosed due to confidentiality obligations, and timing of milestone events is unknown. Acquisition of Pulmatrix shares involves no cash outflow and has broadened strategic options through the waiver of the no-solicitation covenant. Regarding the China business, informed by past manufacturing withdrawal cases, the company has expressed a policy to maximize medium- to long-term shareholder value by leveraging the strengths of a local production and consumption model.
