{"id":1018056,"date":"2026-11-05T23:03:15","date_gmt":"2026-11-06T04:03:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gyre-therapeutics-reports-third-quarter-2026-and-year-to-date-financial-results-with-business-updates\/"},"modified":"2026-11-05T23:03:15","modified_gmt":"2026-11-06T04:03:15","slug":"gyre-therapeutics-reports-third-quarter-2026-and-year-to-date-financial-results-with-business-updates","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gyre-therapeutics-reports-third-quarter-2026-and-year-to-date-financial-results-with-business-updates\/","title":{"rendered":"Gyre Therapeutics Reports Third Quarter 2026 and Year-to-Date Financial Results with Business Updates"},"content":{"rendered":"
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\n Q3 2026 revenue of $32.9 million; GAAP basic EPS: $(0.04)<\/em>\n <\/p>\n

\n Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed<\/em>\n <\/p>\n

SAN DIEGO, Nov. 05, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre, Gyre Therapeutics or the Company) (Nasdaq: GYRE), a U.S. biopharmaceutical company with research operations and commercial business in China to advance global development of protein degrader therapeutics, today announced financial results for the third quarter ended September 30, 2026, and provided a business update.<\/p>\n

Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics, commented, \u201cI am pleased with our execution in the third quarter, our first full quarter incorporating Cullgen’s operations within Gyre Therapeutics. We are advancing our protein degrader pipeline toward first-in-human data and initiating new clinical programs next year. Meanwhile, after recently completing an onsite inspection by China\u2019s National Medical Products Administration, or NMPA, we continue to prepare for the China NMPA decision on F351 for CHB-induced liver fibrosis, which we anticipate launching, if approved, sometime in the first half of 2027. Together, these programs are expected to drive our next phase of growth and demonstrate the strength of our unique business model, combining U.S. innovation with capital-efficient operations in China.\u201d<\/p>\n

\n Third Quarter Business Highlights and Upcoming Milestones<\/u>\n <\/p>\n

\n Pipeline Development Updates<\/em>\n <\/p>\n

\n F351 (hydronidone)<\/strong>\n <\/p>\n

In May 2026, Gyre announced that the Center for Drug Evaluation (CDE) of the NMPA accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis. The acceptance came after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) following the priority review status for F351 granted by the NMPA in March 2026. During the third quarter, Gyre Pharmaceuticals completed an on-site inspection conducted by the NMPA of its manufacturing plants and clinical centers. Gyre believes a decision from the NMPA could occur by the end of 2026 or in the first quarter of 2027.<\/p>\n

\n CG001419 for cancer pain and solid tumors <\/strong>\n <\/p>\n

Following the successful completion of a Phase 1 study in Australia of 78 healthy volunteers in December 2025, Gyre is now planning a Phase 2 study to further evaluate CG001419 in cancer-induced bone pain (CIBP) and other metastatic cancer pain syndromes in China to initiate in the first half of 2027.<\/p>\n

CG001419 continues to separately be evaluated in a Phase 1 trial in China for the treatment of solid tumors.<\/p>\n

\n CG009301 for AML<\/strong>\n <\/p>\n

CG009301 is a GSPT1 degrader for acute myeloid leukemia (AML), a fast-growing cancer of the blood and bone marrow. This candidate continues to be studied in a Phase 1 dose-escalation trial being conducted in China in patients with high-risk hematologic malignancies. We anticipate Phase 1 dose-escalation data to be available in the second half of 2027.<\/p>\n

\n Dual-degrader programs (next-generation targeted protein degraders)<\/strong>\n <\/p>\n

Gyre expects to submit Investigational New Drug (IND) applications and initiate Phase 1 clinical trials, upon regulatory approval of IND applications, in the United States and\/or China around mid-2027 for CG923308, a CDK2-Cyclin E dual degrader for solid tumor indications, and CG620953, a TYK2-JAK1 dual degrader for autoimmune diseases.<\/p>\n

\n DACs, next-generation ADCs<\/strong>\n <\/p>\n

Additional developments from our in-house R&D efforts include discovery\/preclinical stage degrader antibody conjugate (DAC) candidates for solid tumors and hematological malignancies, which are considered the next generation of antibody drug conjugates (ADCs). These DACs consist of distinct protein degraders paired with tumor-specific antibodies. We continue to make progress as we screen to identify leads and look to provide more details on our first IND-ready DAC candidate(s) in 2027.<\/p>\n

\n Pirfenidone for Pneumoconiosis<\/strong>\n <\/p>\n

A Phase 3 trial of pirfenidone for the treatment of pneumoconiosis in China completed enrollment in 2025. A total of 272 patients were enrolled evaluating the efficacy and safety of 52 weeks of pirfenidone capsule treatment in patients with pneumoconiosis versus placebo. The potential for additional patient enrollment is currently being evaluated to replace patients that have dropped out of the study.<\/p>\n

\n Pirfenidone for Radiation-Induced Lung Injury (RILI)<\/strong>\n <\/p>\n

In April 2026, Gyre Pharmaceuticals initiated its adaptive Phase 2\/3 clinical trial in oncology-related pulmonary complications, with the first patient enrolled. The trial is evaluating pirfenidone for RILI, including cases complicated by immune-related pneumonitis, at leading oncology centers.<\/p>\n

\n Commercial Products: <\/em>\n <\/p>\n

\n ETUARY\u2122<\/strong>
\n \u00a0(pirfenidone for IPF), Etorel\u2122 and Contiva\u2122<\/strong>\n <\/p>\n

ETUARY (pirfenidone), the Company’s primary product approved in China for idiopathic pulmonary fibrosis (IPF), generated $31.4 million in sales for the quarter ended September\u00a030, 2026, compared to $27.7 million for the same period in 2025. Etorel (nintedanib ethanesulfonate soft capsules), which was launched in June 2025 and is indicated for systemic sclerosis-associated interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF) and IPF, generated $1.0 million in sales for the quarter ended September\u00a030, 2026, compared to $1.5 million for the same period in 2025. Contiva (avatrombopag maleate tablets), which was launched in China in March 2025 and is indicated for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, generated $0.1 million in sales for the quarter ended September\u00a030, 2026, compared to $1.2 million for the same period in 2025. Contiva and Etorel product revenues were slightly lower due to the implementation of China\u2019s national centralized procurement program.<\/p>\n

\n Financial Results<\/u>\n <\/p>\n

\n Cash Position<\/em>\n <\/p>\n

As of September\u00a030, 2026, Gyre held $41.6 million in cash and cash equivalents, $15.8 million in short-term bank deposits, $12.6 million in short-term investment, and $28.8 million in long-term certificates of deposit, totaling $98.8 million. Compared to $116.1 million as of December 31, 2025, total cash decreased by $17.3 million, or 15%, primarily driven by a decrease in short-term investment of $15.5 million.<\/p>\n

\n Financial Results for the Three Months Ended <\/em>September\u00a030, 2026<\/p>\n