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 Chronic hepatitis B-associated liver fibrosis (PRC); MASH-associated liver fibrosis (US, pre-Phase 2). Its next catalyst on record is F528: NMPA IND submission (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: F528 — NMPA IND submission (2026). 3 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 (PRC; pivotal Phase 3 met primary endpoint; NDA accepted by NMPA May 2026 with priority review) | small molecule | Phase 3 |
| ETUARY (pirfenidone) label expansion | Pneumoconiosis (PRC Phase 3, enrollment complete) | small molecule | Phase 3 |
| ETUARY (pirfenidone) label expansion | Radiation-induced lung injury (PRC adaptive Phase 2/3 initiated April 2026) | small molecule | Phase 2 |
| F573 | Liver injury and liver failure (PRC Phase 2) | small molecule | Phase 2 |
| CG001419 (TRKA degrader) | Pain (Phase 1 completed Dec 2025) and solid tumors (Phase 1, China) | small molecule | Phase 1 |
| CG009301 (GSPT1 degrader) | High-risk hematologic malignancies / AML (Phase 1 in China) | small molecule | Phase 1 |
| F230 | Pulmonary arterial hypertension (PRC Phase 1) | small molecule | Phase 1 |
| F351 US | MASH-associated liver fibrosis (Phase 1 healthy volunteer complete; Phase 2 IND under FDA discussion) | small molecule | Phase 1 |
| CG923308 (CDK2/cyclin E degrader) | CCNE1-amplified solid tumors / HR+ HER2- breast cancer | small molecule | Pre-clinical |
| CG620953 (TYK2/JAK1 degrader) | Autoimmune diseases | small molecule | Pre-clinical |
| F528 | COPD (PRC) | small molecule | Pre-clinical |
| Degrader-antibody conjugates (DACs) | Solid tumors and hematologic malignancies | biologic-other | Pre-clinical |
Recent results and decisions
- Oct 16, 2026n/a Gyre Therapeutics entered into employment agreements with CEO Ying Luo and CFO Thomas Eastling.
On October 16, 2026, Gyre Therapeutics, Inc. entered into an employment agreement with Ying Luo, Ph.D., to continue to serve as Gyre's Chief Executive Officer.
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.