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Gyre Therapeutics ( (GYRE) ) has provided an announcement.
On May 12, 2026, Gyre Therapeutics announced that China’s Center for Drug Evaluation has accepted a New Drug Application for F351 (hydronidone), its lead liver fibrosis candidate, as a treatment for chronic hepatitis B-induced liver fibrosis. The filing, submitted via majority-owned Gyre Pharmaceuticals and granted priority review by the National Medical Products Administration in March, marks Gyre’s second major product NDA in China and the first for F351.
Management framed the acceptance as a significant commercialization milestone that could eventually open access to tens of millions of hepatitis B patients in China who are at risk of liver fibrosis and cirrhosis. The move strengthens Gyre’s positioning in the organ fibrosis market, complementing its established ETUARY franchise in idiopathic pulmonary fibrosis and supporting its broader strategy to leverage China-based development and regulatory progress while advancing F351 into U.S. trials for MASH-related liver fibrosis.
The most recent analyst rating on (GYRE) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Gyre Therapeutics stock, see the GYRE Stock Forecast page.
Spark’s Take on GYRE Stock
According to Spark, TipRanks’ AI Analyst, GYRE is a Neutral.
The score is primarily supported by strong revenue growth, very high gross margins, and a low-debt balance sheet, plus positive corporate catalysts (Cullgen acquisition completion and F351 NDA filing). It is held back by the swing back to losses, inconsistent cash-flow history, and weak technical positioning with the stock trading below major moving averages; valuation is also constrained by a negative P/E and no dividend yield.
To see Spark’s full report on GYRE stock, click here.
More about Gyre Therapeutics
Gyre Therapeutics, Inc. is a commercial-stage biopharmaceutical company headquartered in San Diego with operations in the U.S. and China, focused on developing and commercializing small-molecule therapeutics targeting organ fibrosis and inflammatory diseases. Through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd., it markets ETUARY, a pirfenidone-based treatment for idiopathic pulmonary fibrosis in China and maintains a pipeline led by F351 (hydronidone) for liver fibrosis, while its wholly owned unit Cullgen develops targeted protein degraders and degrader-antibody conjugates for cancer and inflammatory conditions.
Gyre Pharmaceuticals’ portfolio includes late-stage programs for chronic hepatitis B-associated liver fibrosis and other fibrotic and respiratory indications such as Parkinson’s disease, radiation-induced lung injury, COPD, pulmonary arterial hypertension and acute and acute-on-chronic liver failure, reinforcing the group’s focus on fibrotic and inflammatory pathologies. As of March 31, 2026, Gyre Therapeutics held a 69.7% equity interest in Gyre Pharmaceuticals, underscoring its strategic reliance on the China-based unit for both commercial revenue and late-stage development assets.
Average Trading Volume: 98,390
Technical Sentiment Signal: Sell
Current Market Cap: $724.5M
For detailed information about GYRE stock, go to TipRanks’ Stock Analysis page.