Gyre Therapeutics aligns with China's CDE on Hydronidone conditional approval pathway after Pre-NDA meeting

GYRE THERAPEUTICS, INC.

CDE agreed existing Phase 3 data for Hydronidone supports conditional approval NDA for CHB-associated liver fibrosis.
CDE indicated Hydronidone meets priority review criteria; NDA submission planned for H1 2026.
Company will conduct a confirmatory Phase 3c trial to support conversion from conditional to regular approval.
Previously reported Phase 3 met primary endpoint: 52.85% treated vs 29.84% placebo achieved ≥1-stage fibrosis regression (p=0.0002).

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