Gyre Swings to Operating Loss After Cullgen Close

The Tip Desk · November 11, 2026 · 3 min read

Third-quarter revenue was $32.9 million as ETUARY sales rose and the company affirmed 2026 guidance of $100.5 million to $111.0 million.

Gyre Therapeutics (GYRE), a U.S. biopharmaceutical company with commercial operations in China, reported a $1.5 million loss from operations for the three months ended September 30, 2026, reversing $1.5 million of operating income a year earlier. The company said the $3.0 million swing reflected higher operating expenses, including stock-based compensation and Phase 3C and other clinical activity.

Revenue was $32.9 million, up 1% from $32.7 million a year earlier. The quarter was the first full period after Gyre completed its all-stock acquisition of Cullgen Inc. on May 4, 2026, a deal valued at approximately $300 million. President and Chief Executive Officer Dr. Ying Luo said the company was pleased with execution in that first full quarter incorporating Cullgen’s operations.

Gyre Pharmaceuticals revenue increased, which the company attributed primarily to higher ETUARY sales volumes from focused marketing. That lift was offset by a net $1.6 million decrease in collaboration revenue after the Astellas Pharma agreement ended in March 2026.

ETUARY (pirfenidone), the company’s primary product approved in China for idiopathic pulmonary fibrosis, generated $31.4 million in sales in the quarter ended September 30, 2026, compared with $27.7 million in the same period of 2025. Etorel sales were $1.0 million, versus $1.5 million a year earlier. Contiva sales were $0.1 million, versus $1.2 million. Gyre said Contiva and Etorel product revenues were slightly lower due to the implementation of China’s national centralized procurement program.

Cost of revenues was $1.9 million, up 20% from $1.6 million a year earlier, primarily from a $0.5 million increase in Etorel production costs. Selling and marketing expense was $15.0 million, down 2% from $15.3 million, on a $1.1 million reduction in promotional and conference spending after certain first-half promotional objectives were achieved.

Research and development expense was $8.5 million, up 9% from $7.8 million, including a $0.4 million increase in external clinical research tied to F351 Phase 3C experimental review in connection with the China NMPA’s review of the NDA for F351. General and administrative expense was $8.9 million, up 39% from $6.4 million, driven by $0.9 million more personnel costs related to Gyre Pharmaceuticals’ internal restructuring and $1.1 million more professional fees. Transaction costs of $0.1 million were recorded in connection with the Cullgen acquisition.

Net loss was $2.5 million, versus net income of $1.9 million a year earlier. GAAP basic earnings attributable to common stockholders were $(0.04) a share, versus $0.01.

During the third quarter, Gyre Pharmaceuticals completed an on-site inspection by the NMPA of manufacturing plants and clinical centers after the Center for Drug Evaluation accepted the NDA for F351 (hydronidone) for chronic hepatitis B–induced liver fibrosis in May 2026. Gyre said an NMPA decision could occur by the end of 2026 or in the first quarter of 2027, and that it anticipates launching F351, if approved, sometime in the first half of 2027.

The company also said it is planning a Phase 2 study of CG001419 in cancer-induced bone pain in China to initiate in the first half of 2027, expects Phase 1 dose-escalation data for CG009301 in the second half of 2027, and expects to submit IND applications around mid-2027 for dual degraders CG923308 and CG620953, with Phase 1 trials to follow upon regulatory approval of those IND applications.

Cash and related balances totaled $98.8 million as of September 30, 2026, down $17.3 million, or 15%, from $116.1 million as of December 31, 2025, primarily from a $15.5 million decrease in short-term investments. Full-year 2026 revenue guidance of $100.5 million to $111.0 million was affirmed.