Gyre Therapeutics Aligns With China CDE On Conditional Approval Pathway And Priority Review For Hydronidone

Benzinga·01/05/2026 12:20:40

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Gyre Pharmaceuticals completed a Pre-NDA meeting with China's CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review eligibility, subject to formal approval.
Gyre Pharmaceuticals plans to submit an NDA in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China.