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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 (GYRE)Gyre TherapeuticsFDA / regulatory

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

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Gyre Therapeutics

Fibrosis and Inflammation Franchise Gyre Therapeutics is a commercial-stage biopharmaceutical company operating in the United States and China. Its small-molecule portfolio is centered on organ fibrosis and inflammatory diseases. Commercial Products in China Gyre Pharmaceuticals commercializes ETUARY, a pirfenidone therapy for idiopathic...

Recent company news

GYREGyre Therapeutics2026-08-07 11:00 EST

Gyre Therapeutics Reports Second Quarter 2026 and Year-to-Date Financial Results and Provides Business Update

GYREGyre Therapeutics2026-07-16 20:05 EST

Gyre Therapeutics Appoints Three New Members to its Board of Directors

GYREGyre Therapeutics2026-05-12 20:06 EST

Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

GYREGyre Therapeutics2026-05-07 10:00 EST

Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

GYREGyre Therapeutics2026-05-04 12:48 EST

Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

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6.91 USD
Market cap
539.48M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States