GNI Group Ltd.
Announcement Regarding Designation of Priority Review Status by China NMPA for F351, a Treatment for Liver Fibrosis Derived from Chronic Hepatitis B
F351, a treatment for liver fibrosis derived from chronic hepatitis B, has been designated as a priority review item by China NMPA, with a formal NDA submission planned soon.
Key Figures
- Priority Review Designated Drug: F351
- Target Disease: Liver Fibrosis Derived from Chronic Hepatitis B
- NDA Pre-consultation Date: January 6, 2026
AI要約
Priority Review Designation for New Drug F351
Gyre Therapeutics, a consolidated subsidiary of GNI Group Co., Ltd., announced that F351, a treatment for liver fibrosis derived from chronic hepatitis B, has been designated as a priority review item by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This designation followed a pre-consultation held on January 6, 2026, marking a significant milestone in the NDA application process. Gyre Therapeutics plans to submit a formal New Drug Application (NDA) soon.
Future Outlook and China NMPA's Priority Review System
The priority review system was introduced in China in 2017 to accelerate the development and review of new drugs with high clinical value. Approval of F351 is expected to address medical needs for millions of patients with liver fibrosis due to hepatitis B infection in China. Gyre Therapeutics will continue working closely with Chinese authorities to secure approval.
