Gyre Therapeutics Advances Hydronidone Approval Journey in China
On January 5, 2026, Gyre Therapeutics, Inc. (Nasdaq: GYRE) announced a significant advancement for its innovative therapy, Hydronidone, following a Pre-New Drug Application (Pre-NDA) meeting with China's Center for Drug Evaluation (CDE). The agreement reached during the meeting indicates that the existing Phase 3 clinical trial data support a conditional approval filing and priority review eligibility for Hydronidone, aimed at treating chronic hepatitis B (CHB)-associated liver fibrosis.
Conditional Approval Pathway and Next Steps
Gyre Pharmaceuticals, the company’s majority-owned subsidiary in China, plans to submit the New Drug Application (NDA) for Hydronidone in the first half of 2026. As part of the regulatory process, the company will also conduct a confirmatory clinical trial (Phase 3c trial) to substantiate its request for full approval in China.
The CDE's agreement was based on the evidence demonstrating histological improvement in liver fibrosis as quantified by the Ishak fibrosis score. Notably, Hydronidone has been recognized under China's Priority Review and Approval Program for Innovative Drugs.
Significant Clinical Findings
Gyre's Phase 3 trial data indicated that 52.85% of patients treated with Hydronidone experienced a regression of fibrosis at Week 52, significantly higher than the 29.84% seen in the placebo group (p=0.0002). These results affirm Hydronidone's efficacy and safety profile, reinforcing its potential as a groundbreaking therapy for patients with CHB-associated liver fibrosis.
Comments from Leadership
“Hydronidone addresses a significant unmet medical need in patients with CHB-associated liver fibrosis, for whom there are currently no approved anti-fibrotic therapies,” remarked Ping Zhang, Interim Chief Executive Officer of Gyre. He expressed optimism regarding the productive discussions with the CDE, emphasizing the strong clinical data supporting Gyre's path toward conditional approval in China.
About Hydronidone and its Role in the Market
Hydronidone is a novel, orally administered anti-fibrotic agent that targets key liver fibrosis pathways. Its mechanism includes the inhibition of TGF-β1-induced signaling, which plays a significant role in fibrogenesis. Given the high prevalence of chronic hepatitis B in China, affecting an estimated 60–70 million individuals, the need for effective anti-fibrotic treatments like Hydronidone is crucial.
Broader Context in Biopharmaceutical Development
Gyre Pharmaceuticals is committed to advancing therapies for organ fibrosis, with its lead product ETUARY® achieving significant market success since its 2011 launch. The success of Hydronidone could further bolster Gyre's portfolio as it seeks to address a range of fibrotic diseases beyond liver conditions.