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Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting
Gyre Therapeutics, Inc. (GYRE)
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Source: GlobeNewswire
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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 Hydroni
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