Gyre Therapeutics (NASDAQ:GYRE) is moving toward a landmark commercial entry in China after securing alignment with the Center for Drug Evaluation (CDE) on a conditional approval pathway for its lead anti-fibrotic candidate, Hydronidone (F351).
Following a successful Pre-NDA meeting, the company confirmed Monday that it expects to submit a New Drug Application (NDA) in the first half of 2026, targeting a patient population of over 2.6 million currently lacking approved therapies.
The CDE’s support is underpinned by a pivotal Phase 3 study that delivered a stark therapeutic benefit for patients with chronic hepatitis B (CHB)-associated liver fibrosis.
The trial revealed that 52.85% of patients treated with Hydronidone achieved a reduction of at least one stage in fibrosis at Week 52, nearly doubling the 29.84% observed in the placebo arm (p=0.0002).
Given the drug’s Breakthrough Therapy status, the CDE indicated that Hydronidone is eligible for priority review, a designation that could significantly compress the time from filing to market.
To bridge the gap between conditional and regular approval, Gyre will launch a confirmatory Phase 3c clinical trial in China designed to evaluate long-term liver-related clinical outcomes.
Hydronidone represents a next-generation structural analogue of pirfenidone, specifically engineered to inhibit p38γ kinase activity and TGF-β1-driven collagen production while minimizing the hepatotoxicity often seen in previous iterations of anti-fibrotic drugs.