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Gyre Therapeutics Announces China's NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process.

Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range Full year 2026 revenue guidance of $100.5 to $111.0 million Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026 Alignment with China's Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026 Completed patient enrollment in the 52-week Phase 3 pirfenidone pneumoconiosis (PD) trial (272 patients across 18 sites) Hydronidone U.S. Investigational New Drug (IND) application for MASH-associated liver fibrosis anticipated in 2026 SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update. “2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China's CDE,” said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics.

Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline

Acquisition will create a U.S.- and China-based fully integrated biopharmaceutical company with revenue-producing commercial assets and a robust pipeline of degraders, targeting inflammatory diseases and cancers. Access to degrader-antibody conjugates (DACs) platform technology for future discovery engine.

Gyre Therapeutics Announces Alignment with China's CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting

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.