Notice Regarding Submission of New Drug Application (NDA) for F351, a Therapeutic Agent for Liver Fibrosis Derived from Chronic Hepatitis B, in China

Overview of New Drug Application Submission

Gyre Therapeutics, Inc., a consolidated subsidiary of GNI Group, Inc., submitted a New Drug Application (NDA) on March 22, 2026, to the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for F351, a therapeutic agent for liver fibrosis derived from chronic hepatitis B. The application has entered the formal review stage, and will proceed through issuance of acceptance number, technical review, approval, market launch, and application for insurance coverage. Having completed the Pre-NDA meeting and acquired priority review qualification, smooth progress in the review process is anticipated.

Market Significance of F351 and Future Outlook

F351 targets liver fibrosis caused by chronic hepatitis B. In China, where the patient population is large and effective treatments are limited, it has demonstrated robust evidence of liver fibrosis improvement in placebo-controlled Phase 3 clinical trials. It is highly likely to be recommended as the first-line antifibrotic agent in guidelines published by the Chinese Hepatology Society, which is expected to lead to its establishment as standard treatment across nationwide medical institutions centered on tertiary hospitals, promotion for inclusion in national health insurance, and differentiation from existing traditional Chinese medicines. If realized, this will become a significant pillar driving our Group’s earnings.