Announced details
Treatment in China of liver fibrosis caused by chronic hepatitis B
The disclosure states that data demonstrating improvement in liver fibrosis were obtained in a rigorous placebo-controlled Phase 3 clinical trial.
Gyre Therapeutics, Inc. submitted a new drug application to the authorities. Gyre is a consolidated subsidiary of the Company.
The Center for Drug Evaluation (CDE), under China's National Medical Products Administration (NMPA)
The application acceptance number is expected to be issued in the future. Registration number and expiration date: Not disclosed
The disclosure states that F351 is expected to become a strong pillar driving revenue for the Company Group. However, the specific impact of this application on financial results is Not disclosed.
The company does not address Contract Value / Offering price.
Form 8-K publicly filed by Gyre Therapeutics, Inc. (filed 23 March 2026), Hepatology, BMJ Open, and the Company's proprietary market estimates
| Item | Details |
|---|---|
| Names of Products / Services Covered | F351 (treatment for liver fibrosis caused by chronic hepatitis B) |
| Counterparty | Center for Drug Evaluation (CDE), under the National Medical Products Administration (NMPA) of China |
| Counterparty overview | The Center for Drug Evaluation (CDE), under China's National Medical Products Administration (NMPA) |
| Relationship with the Company | Gyre Therapeutics, Inc. submitted a new drug application to the authorities. Gyre is a consolidated subsidiary of the Company. |
| Applicable area | Treatment in China of liver fibrosis caused by chronic hepatitis B |
| Registration number and expiry date | The application acceptance number is expected to be issued in the future. Registration number and expiration date: Not disclosed |
| Quantitative Effects | The disclosure states that data demonstrating improvement in liver fibrosis were obtained in a rigorous placebo-controlled Phase 3 clinical trial. |
| Impact on Business Performance | The disclosure states that F351 is expected to become a strong pillar driving revenue for the Company Group. However, the specific impact of this application on financial results is Not disclosed. |
| Source | Form 8-K publicly filed by Gyre Therapeutics, Inc. (filed 23 March 2026), Hepatology, BMJ Open, and the Company's proprietary market estimates |
Items this document does not state (9)
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.To initiate the formal review process toward obtaining marketing approval for F351 in China.