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
Avatrombopag, F230, F351, and pirfenidone. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Avatrombopag - FDA Regulatory Timeline and 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.
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F230 - FDA Regulatory Timeline and 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.
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F351 - FDA Regulatory Timeline and 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.
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pirfenidone - FDA Regulatory Timeline and 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:
- 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.
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