Gyre Therapeutics Advances Hydronidone Toward China Approval

Gyre Therapeutics ( (GYRE) ) has issued an announcement.

On January 5, 2026, Gyre Therapeutics announced that its majority-owned Chinese subsidiary, Gyre Pharmaceuticals, had completed a Pre-New Drug Application communication meeting with China’s Center for Drug Evaluation, which agreed that existing Phase 3 data on Hydronidone support filing for conditional approval and eligibility for priority review in chronic hepatitis B–associated liver fibrosis, including early cirrhosis. The Phase 3 trial, whose topline results were disclosed on May 22, 2025, showed Hydronidone met its primary endpoint with significantly higher rates of fibrosis regression versus placebo and a favorable safety profile, and the company now plans an additional confirmatory Phase 3c outcomes study in China as part of a regulatory pathway that could accelerate Hydronidone’s entry into a large, underserved Chinese market of an estimated 2.6 million patients with clinically significant CHB-related liver fibrosis, potentially strengthening Gyre’s position in the liver fibrosis segment and broadening its commercial footprint in China.

The most recent analyst rating on (GYRE) stock is a Hold with a $8.50 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.

Gyre Therapeutics’ overall stock score is driven by strong corporate events and positive technical indicators. However, the high P/E ratio suggests overvaluation, and cash flow management issues pose risks. The company’s robust balance sheet and profitability provide a solid foundation, but improvements in cash flow are necessary for sustained financial health.

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

More about Gyre Therapeutics

Gyre Therapeutics is a San Diego–based, commercial-stage biopharmaceutical company focused on developing and commercializing anti-fibrotic therapies, led by its first-in-class liver fibrosis candidate Hydronidone and supported by its indirect controlling interest in China’s Gyre Pharmaceuticals. In China, Gyre Pharmaceuticals markets ETUARY (pirfenidone) for idiopathic pulmonary fibrosis, generating $105.8 million in net sales in 2024 and maintaining a leading market share, while advancing a pipeline of fibrosis-focused drugs, including Hydronidone and additional candidates for conditions such as Parkinson’s disease, radiation-induced lung injury, COPD, pulmonary arterial hypertension and acute and acute-on-chronic liver failure.

Average Trading Volume: 77,395

Technical Sentiment Signal: Sell

Current Market Cap: $619M

For detailed information about GYRE stock, go to TipRanks’ Stock Analysis page.