Gyre Therapeutics has secured priority review status for its anti‑fibrotic candidate Hydronidone (F351) from the China National Medical Products Administration’s Center for Drug Evaluation (CDE). The designation, granted after a pre‑NDA meeting on January 5 2026, signals that the CDE will allocate additional resources to evaluate the application more quickly, potentially shortening the review timeline and accelerating market entry.
Hydronidone is a pirfenidone derivative designed to treat chronic hepatitis B–induced liver fibrosis. A Phase 3 trial conducted in China met its primary endpoint, showing statistically significant fibrosis regression (p < 0.0002). The company plans to submit the formal NDA soon, positioning the drug for approval in 2026 and expanding its portfolio beyond its existing IPF therapy, ETUARY.
Gyre’s Q4 2025 results showed revenue of $37.2 million, up 33.3 % year‑over‑year, driven by strong sales of ETUARY and contributions from newly launched products Etorel and Contiva. The company posted a net loss of $1.4 million, an EPS loss of $0.02 versus an estimate of $0.08, largely because selling and marketing expenses rose as the company invested in promotional activities for its growing pipeline.
Full‑year 2025 revenue reached $116.6 million, up 10.2 % from $105.8 million in 2024, and the company reported a net income of $9.9 million. For 2026, Gyre guided revenue of $100.5 million to $111 million, a decline that reflects a shift toward regulatory activities and a moderation of promotional spending amid market uncertainty.
The priority review designation is a key milestone for Gyre’s China‑centric commercial strategy, potentially unlocking a significant revenue stream in a market where hepatitis B affects tens of millions of patients. The company’s recent acquisition of Cullgen adds a protein‑degradation platform to its pipeline, while plans for a U.S. Phase 2 trial for MASH‑associated fibrosis and the integration of Cullgen signal a broader expansion beyond liver fibrosis.
"I am very pleased to see the decision by the Chinese CDE to grant priority review to our NDA for F351. It underscores both the urgency of the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. HBV infection affects tens of millions of patients in China and a significant number of them will develop liver fibrosis and eventually cirrhosis. If approved, F351 could address the need for these patients. We thank the agency for their continued support to advance therapies for liver fibrosis patients in need of treatment and look forward to working closely with CDE to move F351 toward approval." – Ping Zhang, Executive Chairman of Gyre
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