Gyre Therapeutics, Inc. reports commercial-stage biopharmaceutical developments tied to organ fibrosis, inflammatory diseases and cancer-focused pipeline expansion. The company generates revenue through Gyre Pharmaceuticals in China, including ETUARY® (pirfenidone) and other commercial products, while advancing Hydronidone (F351) for chronic hepatitis B-associated liver fibrosis and MASH-associated liver fibrosis.
Recurring updates include quarterly results, revenue guidance, China NMPA and CDE interactions, NDA disclosures for F351, pirfenidone indication-expansion studies in lung fibrosis, and integration of Cullgen’s targeted protein degrader and degrader antibody conjugate candidates after the completed acquisition.
Gyre Therapeutics (NASDAQ: GYRE) announced completion of patient enrollment in its 52-week Phase 3 trial of Pirfenidone capsules for pneumoconiosis on Oct 15, 2025. The randomized, double-blind, placebo-controlled study enrolled 272 patients across 18 centers in China to evaluate 52 weeks of treatment for progressive pulmonary fibrosis caused by mineral dust exposure. The company noted a significant unmet medical need: no approved therapies in China specifically target fibrotic mechanisms in pneumoconiosis, which affects >450,000 surviving patients in China. The trial completion of enrollment is a key operational milestone ahead of safety and efficacy readouts.
Gyre Therapeutics (Nasdaq: GYRE) will present results from a positive Phase 3 trial of Hydronidone for treatment of liver fibrosis in chronic hepatitis B at AASLD The Liver Meeting® 2025.
The abstract was selected as a Poster of Distinction. Presentation details: Phase 3 Trial of Hydronidone for Liver Fibrosis in Chronic Hepatitis B, presenting author Prof. Lungen Lu, M.D., Session: Hepatitis B ("1187-1367"), Date: Friday, November 7, 2025, Time: 8:00 a.m.–5:00 p.m. ET, Publication Number: 1121. The meeting runs November 7–10, 2025 in Washington D.C.
Gyre Therapeutics (Nasdaq: GYRE), a commercial-stage biopharmaceutical company focused on fibrosis-first therapies, will participate in the H.C. Wainwright 27th Annual Global Investment Conference. The company's management will deliver their presentation on September 10, 2025, at 12:30 p.m. ET.
Investors can register in advance for the presentation webcast, which will be available on Gyre's website Events and Presentations page. A replay will be accessible after the live session.
Gyre Therapeutics (NASDAQ: GYRE), a commercial-stage biopharmaceutical company focused on fibrosis-first therapies, has appointed Dr. Dan Weng to its Board of Directors effective August 18, 2025.
Dr. Weng brings nearly 40 years of experience in managing global clinical trials and currently serves as President and CEO of Medelis, Inc. His extensive background includes executive positions at major CROs and research roles at prestigious institutions including Harvard Medical School and Massachusetts General Hospital.
The appointment comes at a strategic time as Gyre aims to expand its commercial reach and advance its multi-national pipeline. Dr. Weng's expertise in regulatory affairs and clinical trial management is expected to support the company's growth initiatives.
Gyre Therapeutics (NASDAQ:GYRE) reported Q2 2025 financial results with revenue of $26.8 million and net income of $1.6 million. The company announced a leadership change as Ping Zhang, Executive Chairman, was appointed interim CEO while Dr. Han Ying transitions to SVP of Science.
Key highlights include positive Phase 3 results for Hydronidone in CHB-associated liver fibrosis, successful launch of Etorel for SSc-ILD and PF-ILD treatments, and NMPA approval for pirfenidone clinical trials. The company reaffirmed its full-year 2025 revenue guidance of $118-128 million.
Financial position remains strong with $75.9 million in total cash and investments, bolstered by a $23 million public offering completed in May 2025.
Gyre Therapeutics (NASDAQ: GYRE) has announced the pricing of its public offering of 2,222,222 shares of common stock at $9.00 per share, aiming to raise approximately $20.0 million in gross proceeds. The underwriters have a 30-day option to purchase up to an additional 333,333 shares. The offering is expected to close around May 27, 2025.
The biotechnology company plans to use the proceeds to advance its Phase 2 clinical trial of F351 in MASH-associated liver fibrosis in the United States, fund research and development, manufacturing scale-up, and support working capital needs. Jefferies is serving as the lead book-running manager, with H.C. Wainwright & Co. as co-manager for the offering.