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Gyre posts flat Q3 revenue of $32.9m as China decision on F351 nears

🇺🇸 Gyre Therapeutics, Inc. (GYRE) · Thu 05 Nov 2026

Gyre Therapeutics affirmed full-year guidance after Q3 results, with an NMPA ruling on hydronidone (F351) for CHB-induced liver fibrosis possible by end-2026 or Q1 2027.

Gyre Therapeutics reported third-quarter 2026 revenue of $32.9 million on 5 November 2026, broadly unchanged from the same period a year earlier. The company affirmed its full-year revenue guidance of $100.5 million to $111.0 million.

The main regulatory event is the pending review of F351 (hydronidone) in China. The National Medical Products Administration (NMPA) has recently completed an on-site inspection of Gyre Pharmaceuticals' plants and clinical centres. The inspection relates to the new drug application for F351 in liver fibrosis caused by chronic hepatitis B (CHB), which is under priority review.

According to Gyre, a decision could come by the end of 2026 or in the first quarter of 2027. By way of general context, on-site inspections of manufacturing and clinical sites are a standard step before regulators approve a new drug application.

On the commercial side, sales of Contiva and Etorel fell under China's national centralised procurement programme. Sales of ETUARY (pirfenidone), used in idiopathic pulmonary fibrosis (IPF), grew to $31.4 million.

What it means for your team

  • Market-access teams in China should note that products brought under national centralised procurement, as Contiva and Etorel were, can see sales decline.
  • Regulatory teams can read the completed NMPA on-site inspection as a sign that the F351 priority-review application is at a late stage, with a decision possible by end-2026 or Q1 2027.
  • ETUARY, which accounts for most of the quarter's revenue at $31.4 million, shows how heavily Gyre's current sales depend on its IPF product.

Company's press release (SEC filing): Gyre Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Gyre Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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