Gyre holds 2026 revenue outlook as China regulator weighs liver fibrosis drug
Flat third-quarter sales leave Gyre dependent on its IPF drug while it awaits a Chinese approval decision on hydronidone, possibly by year-end.
Gyre Therapeutics reported third-quarter 2026 revenue of $32.9 million on 5 November, broadly in line with the same quarter a year earlier. The company kept its full-year revenue guidance at $100.5 million to $111.0 million.
The quarter's revenue was concentrated in one product. ETUARY (pirfenidone), prescribed for idiopathic pulmonary fibrosis, grew to $31.4 million, which accounts for nearly all of the $32.9 million total. Two other products, Contiva and Etorel, fall under China's national centralised procurement programme. Sales of both fell in the period.
The main upside for Gyre lies in the pipeline. China's National Medical Products Administration (NMPA) has recently finished an on-site inspection of the plants and clinical centres of Gyre Pharmaceuticals. The inspection relates to the new drug application for F351 (hydronidone) in liver fibrosis caused by chronic hepatitis B, which is under priority review. Gyre said a decision could arrive by the end of 2026 or in the first quarter of 2027.
As general context, regulators typically inspect manufacturing and clinical sites before approving a new drug application. Gyre has not said what the inspection found.
Why it matters
- Gyre's current sales depend heavily on ETUARY, which made up $31.4 million of the $32.9 million quarterly revenue.
- Contiva and Etorel show how inclusion in China's national centralised procurement can weigh on sales, a point for market-access teams to weigh.
- A completed NMPA site inspection suggests the priority-review application for F351 is at a late stage, with a decision possible by end-2026 or Q1 2027.
- Unchanged full-year guidance of $100.5 million to $111.0 million leaves the company's near-term revenue outlook as before.
Company's press release (SEC filing): Gyre Therapeutics, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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