Gyre Therapeutics, Inc.

What they do

Gyre operates through majority indirectly owned Gyre Pharmaceuticals in the PRC and U.S. operations headquartered in San Diego, California. It markets ETUARY (pirfenidone), Etorel (nintedanib) and Contiva (avatrombopag) in China for fibrotic and related diseases. It is developing F351 (hydronidone) for liver fibrosis and, after acquiring Cullgen in May 2026, targeted protein degrader and degrader-antibody conjugate therapies.

Revenue drivers

• ETUARY (pirfenidone) — Primary product approved in China for idiopathic pulmonary fibrosis; generated $28.0 million in Q2 2026, up from $23.5 million a year earlier, and dominates total revenue.
• Etorel (nintedanib) — Launched June 2025 for systemic sclerosis-associated interstitial lung disease and progressive pulmonary fibrosis; generated $0.3 million in Q2 2026 versus $1.6 million in Q2 2025, a small and declining contributor.
• Contiva (avatrombopag) — Launched March 2025 for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura; generated $0.9 million in Q2 2026 versus $1.5 million in Q2 2025.

Recent performance

Second quarter 2026 revenue was $29.1 million, with GAAP basic EPS of $(0.12). ETUARY sales rose to $28.0 million from $23.5 million in the prior-year quarter, while Etorel fell to $0.3 million from $1.6 million and Contiva to $0.9 million from $1.5 million. Full-year 2025 revenue was $116.6 million with net income of $9.9 million, and annual revenue has ranged from $102.3 million to $116.6 million since 2022. Cash and equivalents were $43.3 million and shareholder equity $107.9 million at June 30, 2026. Full year 2026 revenue guidance of $100.5 to $111.0 million was affirmed.

Strategy

Management intends to use the established Chinese commercial portfolio to fund and de-risk late-stage candidates, expand approved products into new indications, and build a diversified fibrosis pipeline. F351 (hydronidone) is the lead candidate, with an NDA for CHB-induced liver fibrosis accepted by China's CDE in May 2026 after priority review status in March. The company completed the Cullgen all-stock acquisition in May 2026, adding targeted protein degraders and degrader-antibody conjugates across pain, cancer and inflammatory diseases. Cullgen's former CEO, CSO and CFO took the same roles at Gyre, and the combined company has roughly 740 employees with subsidiaries in Beijing and Shanghai. Management says it is reviewing programs to optimize capital allocation and expects to leverage Cullgen's China capabilities for early-stage development.

Risks

• Product concentration — Business depends significantly on ETUARY sales in a competitive PRC antifibrotic market, and the company may not sustain its sales volume, pricing or profitability.
• Commercial acceptance — ETUARY, Etorel, Contiva and future approved products may fail to gain sufficient acceptance among physicians, hospitals, pharmacies, patients and third-party payers.
• Pipeline execution — Growth depends on clinical and regulatory success for ETUARY in new indications, F573 and Hydronidone in the PRC and beyond, which may not be completed, approved or launched.
• Merger integration — The Cullgen acquisition closed in May 2026, and the combined organization may not realize the expected benefits or successfully integrate the degrader pipeline and team.

Outlook

Management affirmed full year 2026 revenue guidance of $100.5 to $111.0 million. It highlighted the F351 NDA acceptance for CHB-induced liver fibrosis in China, the Cullgen acquisition, and increased Gyre Pharmaceuticals sales as recent progress. Upcoming milestones include a Phase 3 pirfenidone trial in pneumoconiosis, with enrollment of 272 patients completed in 2025 and the final patient expected to finish by the fourth quarter of 2026, and an adaptive Phase 2/3 trial in radiation-induced lung injury initiated in April 2026.