Gyre reports Q2 2026 results, advances F351 NDA and Cullgen pipeline

Gyre Therapeutics reported second quarter 2026 results on August 7, 2026, with revenue of $29.1 million and a GAAP basic loss per share of $0.12, alongside affirmed full-year 2026 revenue guidance of $100.5 to $111.0 million.¹

On the regulatory front, China's National Medical Products Administration accepted the New Drug Application for F351, also called hydronidone, as a treatment for chronic hepatitis B-induced liver fibrosis in May 2026.¹ The filing followed priority review status granted to F351 by the NMPA in March, and the NDA was submitted through Gyre's majority-owned subsidiary Gyre Pharmaceuticals.¹

In pneumoconiosis, a Phase 3 trial of pirfenidone in China completed enrollment in 2025, with 272 patients evaluated for 52 weeks of treatment versus placebo.¹ The company said the last enrolled patient is on track to finish the study by the fourth quarter of 2026.

Separately, Gyre began an adaptive Phase 2/3 trial in April 2026 for radiation-induced lung injury, including cases with immune-related pneumonitis, enrolling its first patient at oncology centers.¹

On the Cullgen side, acquired in May 2026, a Phase 1 study in Australia of 78 healthy volunteers for CG001419 finished in December 2025, and Gyre is now planning a Phase 2 study in cancer-induced bone pain or other metastatic cancer pain syndromes.¹ Gyre also expects to file INDs in the U.S. and/or China in the first quarter of 2027 for two additional degrader candidates, CG923308 and CG620953.¹

On cash, Gyre held $103.2 million in total cash, deposits and investments as of June 30, 2026, down from $116.1 million at the end of 2025, a decrease of $12.9 million or 11%, driven mainly by a $10.6 million drop in short-term investments.¹