[GNI Group] New Drug Approval Application Accepted in China | May 2026

Performance Overview

This material reports that GNI Group's consolidated subsidiary Gyre Pharmaceuticals has officially received acceptance of its new drug application (NDA) from China's National Medical Products Administration (NMPA). F351 is a treatment for liver fibrosis due to chronic hepatitis B, with the application submitted in March 2026, and has entered the review process. F351 has been designated as a priority review product and is expected to be an innovative medicine with high clinical value. The progress toward approval is expected to enhance the market entry and social significance of the drug.

Future Outlook

Depending on the progress of new drug approval in China, there could be an impact on consolidated performance for the fiscal year ending December 2026. However, in the long term, it is believed to contribute to increased corporate and social value. Details regarding the timing of approval and market launch will be announced in future disclosures.