This section highlights FDA-related milestones and regulatory updates for drugs developed by Gyre Therapeutics (GYRE).
Over the past two years, Gyre Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
pirfenidone, Hydronidone, F230, F351, and Avatrombopag. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Pirfenidone FDA Regulatory Events
Pirfenidone is a drug developed by Gyre Therapeutics for the following indication: In Oncology-Related Pulmonary Complications.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- pirfenidone
- Announced Date:
- October 15, 2025
- Indication:
- In Oncology-Related Pulmonary Complications
Announcement
Gyre Therapeutics announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis.
AI Summary
Gyre Therapeutics’ indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., has completed enrollment of 272 patients in a 52-week Phase 3 trial of Pirfenidone capsules for pneumoconiosis. The multicenter, randomized, double-blind, placebo-controlled study is underway at 18 research centers across China to assess the drug’s efficacy and safety in this fibrosis-driven lung disease.
The trial’s primary endpoint is the change from baseline in forced vital capacity (FVC) percentage predicted at Week 52. Key secondary measures include lung diffusion capacity, six-minute walk distance, respiratory symptom scores and rates of acute exacerbations, hospitalizations, and deaths. Participants receive 1,800 mg of Pirfenidone daily, and safety monitoring follows the company’s Development Safety Update Report. To date, adverse events have been mostly mild or moderate, with no unexpected safety concerns, and no interim analysis is planned.
Pneumoconiosis affects over 450,000 people in China and has no approved antifibrotic therapy. Pirfenidone, an oral small molecule approved in China in 2011 for idiopathic pulmonary fibrosis, inhibits TGF-β signaling and fibroblast proliferation. This trial seeks to meet a critical unmet need by slowing or halting lung fibrosis progression in affected workers.
Read Announcement- Drug:
- pirfenidone
- Announced Date:
- March 31, 2025
- Indication:
- In Oncology-Related Pulmonary Complications
Announcement
Gyre Therapeutics announced that the National Medical Products Administration (NMPA) of the People's Republic of China ("PRC") has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications.
AI Summary
Gyre Therapeutics announced that China’s National Medical Products Administration (NMPA) approved its clinical trial application for a new oncology use of pirfenidone. The drug, traditionally used for idiopathic pulmonary fibrosis (IPF), will now be evaluated as a treatment option for pulmonary complications in cancer patients. Specifically, the trial will assess pirfenidone capsules for radiation-induced lung injury (RILI), either alone or in combination with immune checkpoint inhibitor-related pneumonitis (CIP).
This adaptive Phase 2/3 clinical trial aims to find the best dose while confirming the drug’s effectiveness. By targeting fibrotic pathways, pirfenidone could provide a novel lung-protective strategy for patients undergoing radiation therapy or immunotherapy, who often face harmful lung injuries. The NMPA’s approval marks an important step in expanding the drug’s potential benefits beyond its established role in treating IPF.
Read Announcement
Hydronidone FDA Regulatory Events
Hydronidone is a drug developed by Gyre Therapeutics for the following indication: Treatment of Liver Fibrosis in Chronic Hepatitis B.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Hydronidone
- Announced Date:
- October 14, 2025
- Indication:
- Treatment of Liver Fibrosis in Chronic Hepatitis B
Announcement
Gyre Therapeutics announced that it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).
AI Summary
Gyre Therapeutics, a commercial-stage biopharmaceutical company, will share findings from its positive Phase 3 trial of Hydronidone at The Liver Meeting® 2025, the American Association for the Study of Liver Diseases annual conference in Washington, D.C. Hydronidone is a new anti-fibrotic drug designed to block hepatic stellate cell activation and trigger their apoptosis, targeting liver fibrosis in people with chronic hepatitis B.
The company’s abstract was chosen as a Poster of Distinction. Professor Lungen Lu from Shanghai General Hospital will present the data on Friday, November 7, 2025, between 8:00 a.m. and 5:00 p.m. Eastern Time (Publication Number 1121, Session “Hepatitis B 1187-1367”).
Gyre Therapeutics focuses on fibrosis-first treatments across various organ systems. Hydronidone is at the center of its U.S. development efforts for liver fibrosis and metabolic dysfunction–associated steatohepatitis. In China, Gyre advances a broader pipeline through its indirect interest in Gyre Pharmaceuticals.
Read Announcement
F230 FDA Regulatory Events
F230 is a drug developed by Gyre Therapeutics for the following indication: For the treatment of pulmonary arterial hypertension ("PAH").
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- F230
- Announced Date:
- June 10, 2025
- Indication:
- For the treatment of pulmonary arterial hypertension ("PAH").
Announcement
Gyre Therapeutics announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A ("ETA") receptor antagonist, for the treatment of pulmonary arterial hypertension ("PAH").
AI Summary
Gyre Therapeutics announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial for F230, a novel endothelin A (ETA) receptor antagonist aimed at treating pulmonary arterial hypertension (PAH). PAH is a progressive and life-threatening condition that currently has limited treatment options. F230 is designed to block the ETA receptor, which may help reduce pulmonary pressure and slow the harmful remodeling of lung blood vessels associated with PAH. The trial will evaluate the safety, tolerability, and pharmacokinetics of F230 in healthy volunteers. This milestone represents an important step as Gyre Therapeutics enters the PAH field, potentially opening the door to new therapeutic options for patients suffering from this severe cardiovascular disease.
Read Announcement
F351 FDA Regulatory Events
F351 is a drug developed by Gyre Therapeutics for the following indication: For Chronic Hepatitis B.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- F351
- Announced Date:
- May 22, 2025
- Indication:
- For Chronic Hepatitis B
Announcement
Gyre Therapeutics announced that its lead compound, Hydronidone (F351), met the primary endpoint in a pivotal Phase 3 trial evaluating its efficacy and safety for the treatment of liver fibrosis in patients with chronic hepatitis B ("CHB") in China.
AI Summary
Gyre Therapeutics announced that its lead compound, Hydronidone (F351), met the primary endpoint in a pivotal Phase 3 trial for treating liver fibrosis in chronic hepatitis B patients in China. The 52-week, double-blind, placebo-controlled study involved 248 patients across 39 hospitals. Results showed that significantly more patients receiving Hydronidone achieved a regression of at least one stage of liver fibrosis compared to those on placebo. The trial reported a robust efficacy signal along with a favorable safety profile, with lower serious adverse events and no treatment discontinuations due to adverse events.
These promising outcomes support Gyre’s plan to file for accelerated approval with China’s National Medical Products Administration (NMPA), with a New Drug Application submission slated for the third quarter of 2025. Hydronidone could become the first therapy specifically approved for reversing liver fibrosis in chronic hepatitis B patients in China, marking a major breakthrough in treatment.
Read Announcement- Drug:
- F351
- Announced Date:
- March 27, 2025
- Indication:
- For Chronic Hepatitis B
Announcement
Gyre Therapeutics announced the publication of the manuscript titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial" in the Journal of Clinical and Translational Hepatology.
AI Summary
Gyre Therapeutics has recently published a manuscript in the Journal of Clinical and Translational Hepatology detailing the full protocol for its pivotal Phase 3 trial. The paper, titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial," outlines the study design that evaluates hydronidone as a treatment for liver fibrosis linked to chronic hepatitis B in Chinese patients. The manuscript clearly explains the inclusion criteria, patient randomization, blinding methods, key assessments, and the statistical analysis plan. In this randomized, double-blind, placebo-controlled, multicenter trial (NCT05115942), 248 patients were enrolled across 44 clinical research hospitals. This publication not only demonstrates Gyre’s commitment to transparency but also highlights their systematic approach to measuring a reduction in liver fibrosis after 52 weeks of treatment, contributing valuable insights to the field of organ fibrosis therapy.
Read Announcement
Avatrombopag FDA Regulatory Events
Avatrombopag is a drug developed by Gyre Therapeutics for the following indication: For the Treatment of CLD-Associated Thrombocytopenia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Avatrombopag
- Announced Date:
- July 2, 2024
- Indication:
- For the Treatment of CLD-Associated Thrombocytopenia
Announcement
Gyre Therapeutics announced that China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia ("TP") associated with chronic liver disease ("CLD") in adult patients undergoing elective diagnostics procedures or therapy.
AI Summary
Gyre Therapeutics announced that China’s National Medical Products Administration (NMPA) has approved avatrombopag maleate tablets—developed by Gyre Pharmaceuticals, an indirectly controlled subsidiary—for treating thrombocytopenia (TP) associated with chronic liver disease (CLD) in adult patients undergoing elective diagnostic procedures or therapy. TP is a common and potentially life-threatening complication in patients with CLD. The approval marks an important milestone for Gyre as it expands its rare disease product lineup. Previously, the U.S. Food and Drug Administration (FDA) had approved the oral thrombopoietin receptor agonist for similar use, and this new approval is expected to help address the unmet treatment needs in China. With this move, Gyre Therapeutics looks forward to launching avatrombopag in the Chinese market and delivering improved care for patients battling chronic liver disease.
Read Announcement
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