Gyre Therapeutics, Inc. GYRE
Gyre Therapeutics, Inc. (Nasdaq: GYRE) is a GI/hepatology drug developer. Its lead program, F351 (hydronidone), is in Phase 3 for CHB-associated liver fibrosis. Its next catalyst on record is F528: IND application submission to NMPA for COPD (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: F528 — IND application submission to NMPA for COPD (2026). 6 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| F351 (hydronidone) | CHB-associated liver fibrosis | small molecule | Phase 3 |
| F573 | Liver injury and liver failure | small molecule | Phase 2 |
| F351 (hydronidone) | MASH-associated liver fibrosis (US) | small molecule | Phase 1 |
| CG001419 | Pain (CIBP or metastatic cancer pain) | small molecule | Phase 1 |
| CG001419 | Solid tumors (TRK gene abnormalities) | small molecule | Phase 1 |
| CG009301 | Acute myeloid leukemia (AML) and high-risk hematologic malignancies | small molecule | Phase 1 |
| F230 | Pulmonary arterial hypertension (PAH) | small molecule | Phase 1 |
| CG923308 | Solid tumors (CCNE1 amplification or HR+/HER2- breast cancer) | small molecule | Pre-clinical |
| CG620953 | Autoimmune diseases | small molecule | Pre-clinical |
| F528 | Chronic obstructive pulmonary disease (COPD) | small molecule | Pre-clinical |
| Degrader-Antibody Conjugates (DACs) | Solid tumors and hematological malignancies | biologic-other | Pre-clinical |
Recent results and decisions
- May 31, 2026accepted China's NMPA accepted the New Drug Application for F351 for CHB-induced liver fibrosis in May 2026.
In May 2026, Gyre announced that the Center for Drug Evaluation (CDE) of the NMPA accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis.
Filing - May 12, 2026accepted China NMPA/CDE accepted the NDA for F351 (hydronidone) in CHB-induced liver fibrosis; priority review status previously granted in March (ex-US).
the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis
Filing - Mar 12, 2026completed enrollment Completed enrollment of 272 patients across 18 sites in 52-week Phase 3 pirfenidone pneumoconiosis trial (enrollment completed Q3 2025).
Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients across 18 sites)
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 GI/hepatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.