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)
Company Research
Source: GlobeNewswire
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. SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (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 that its majority-owned subsidiary in China, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), completed a Pre–New Drug Application (Pre-NDA) communication meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) regarding Hydronidone, the Company’s first-in-class anti-fibrotic
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News
- Gyre Therapeutics Announces Alignment with China's CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting [Yahoo! Finance]Yahoo! Finance
- Gyre Therapeutics (NASDAQ:GYRE) was upgraded by analysts at Zacks Research from a "strong sell" rating to a "hold" rating.MarketBeat
- Is Gyre Therapeutics, Inc.'s (NASDAQ:GYRE) ROE Of 8.6% Concerning? [Yahoo! Finance]Yahoo! Finance
- Gyre Therapeutics Reports Third Quarter 2025 and Year-to-Date Financial Results and Provides Business UpdateGlobeNewswire
- Gyre Therapeutics (NASDAQ:GYRE) was downgraded by analysts at Zacks Research from a "hold" rating to a "strong sell" rating.MarketBeat
GYRE
Earnings
- 11/7/25 - Miss
GYRE
Sec Filings
- 1/9/26 - Form 4
- 1/9/26 - Form 4
- 1/5/26 - Form 8-K
- GYRE's page on the SEC website