Acceptance in China of the New Drug Application (NDA) for F351, a Treatment for Liver Fibrosis Associated with Chronic Hepatitis B
Gyre Pharmaceuticals Co., Ltd. (Beijing Continent), an operating subsidiary of Gyre Therapeutics, Inc.
F351 (generic name: hydronidone), China, indication for liver fibrosis associated with chronic hepatitis B
A formal acceptance number was issued following the CDE's review of the application documents for format and completeness
Fiscal year ending December 2026
The impact of this matter on consolidated results for the fiscal year ending December 2026 is currently under review
Related procedures
Acceptance of the New Drug Application (NDA) and transition to substantive review
The Center for Drug Evaluation (CDE), under China's National Medical Products Administration (NMPA)
The review is expected to progress, leading to approval and commercialization. The company will promptly disclose any matters that arise requiring future disclosure based on the progress of the review.
If any matters requiring disclosure arise, the Company will promptly disclose them.
| Item | Details |
|---|---|
| Event name | Acceptance in China of the New Drug Application (NDA) for F351, a Treatment for Liver Fibrosis Associated with Chronic Hepatitis B |
| Subject Entity | Gyre Pharmaceuticals Co., Ltd. (Beijing Continent), an operating subsidiary of Gyre Therapeutics, Inc. |
| Target Locations / Products | F351 (generic name: hydronidone), China, indication for liver fibrosis associated with chronic hepatitis B |
| Cause | A formal acceptance number was issued following the CDE's review of the application documents for format and completeness |
| Accounting period in which recognized | Fiscal year ending December 2026 |
| Impact on Earnings Forecast | The impact of this matter on consolidated results for the fiscal year ending December 2026 is currently under review |
| Type of litigation or proceeding | Acceptance of the New Drug Application (NDA) and transition to substantive review |
| Court or authority | The Center for Drug Evaluation (CDE), under China's National Medical Products Administration (NMPA) |
| Outlook | The review is expected to progress, leading to approval and commercialization. The company will promptly disclose any matters that arise requiring future disclosure based on the progress of the review. |
| Planned follow-up disclosure | If any matters requiring disclosure arise, the Company will promptly disclose them. |
Items this document does not state (15)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.A formal acceptance number was issued following the CDE's review of the application documents for format and completeness.