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Gyre Therapeutics Files NDA in China for F351

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Gyre Therapeutics Files NDA in China for F351

Meet Samuel – Your Personal Investing Prophet

Gyre Therapeutics ( (GYRE) ) has provided an update.

On March 22, 2026, Gyre Pharmaceuticals submitted a New Drug Application to China’s Center for Drug Evaluation for F351 (Hydronidone), its lead therapy for chronic hepatitis B-induced liver fibrosis. The filing marked a key regulatory milestone for Gyre Therapeutics’ liver disease portfolio and, if accepted for technical review, could advance the company’s position in China’s growing market for advanced treatments of chronic liver conditions.

Following the March 22 submission, the application was first subject to formatting and completeness checks, with the company prepared to provide supplementary materials requested by regulators. The Center for Drug Evaluation was then expected to issue an acceptance number before starting its technical review, a procedural step that signaled progress toward potential approval and commercialization in a major healthcare market.

The most recent analyst rating on (GYRE) stock is a Buy with a $7.50 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 driven primarily by improving profitability and a low-leverage balance sheet, but weighed down by weak cash conversion and negative free cash flow. Technicals also detract due to below-average price trends and negative MACD, while valuation appears demanding at ~33x earnings. Offsetting these risks, recent corporate developments (China regulatory progress and the Cullgen acquisition) add meaningful strategic upside.

To see Spark’s full report on GYRE stock, click here.

More about Gyre Therapeutics

Gyre Therapeutics, Inc., through its majority indirectly owned subsidiary Gyre Pharmaceuticals Co., Ltd., operates in the biopharmaceutical industry and focuses on developing innovative therapies for serious liver diseases. Its lead product candidate, F351 (Hydronidone), targets chronic hepatitis B-induced liver fibrosis, positioning the company in a specialized segment of the liver disease treatment market.

Average Trading Volume: 96,904

Technical Sentiment Signal: Sell

Current Market Cap: $610.8M

See more insights into GYRE stock on TipRanks’ Stock Analysis page.

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