Developing Anti-Fibrotic Therapeutics for Chronic Organ Diseases Corporate Presentation April 2025 This presentation concerns a discussion of investigational drugs that are under preclinical and/or clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representations are made as to their safety or effectiveness for the purposes for which they are being investigated. 2 Gyre T ...

About Gyre Therapeutics SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A ("ETA") receptor antagonist, for the treatment of pulmonary arterial hypertension ("PAH"). This milestone mar ...

SAN DIEGO, May 29, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that it closed its previously announced underwritten public offering of 2,555,555 shares of its common stock, including the full exercise by the underwriters of their option to purchase an additional 333,333 shares, at a public offering price of $9.00 p ...

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced the pricing of its previously announced underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share. In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 333,333 shares of its common stock at the p ...

SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The prop ...

Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002).Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events.Breakthrough Therapy Designation granted by China’s National Medical Products Administration (“NMPA”) in 2021 supports potential first-in-class approval in CHB-associated liver fibrosis (“CHB fibrosis”).Gyre intends to seek accelerated approva ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51173 Gyre Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 56-2020050 (State or Other Jurisd ...

Net Income of $3.7 million; reaffirms Full-Year Revenue Guidance of $118–$128 millionQ1 2025 revenue of $22.1 million; GAAP basic EPS: $0.03Completed data collection and achieved database lock for the pivotal Phase 3 trial of Hydronidone in Chronic Hepatitis B (“CHB”)-associated liver fibrosis; currently reviewing data and on track to report topline results in Q2 2025Received IND approval from China’s National Medical Products Administration (“NMPA”) for a new indication of pirfenidone to treat radiation-in ...

SAN DIEGO, May 9, 2025 (GLOBE NEWSWIRE) – Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced financial results for the first quarter ended March 31, 2025 and provided a business update. "This quarter marked a meaningful step forward in expanding our market presence, particularly in the liver space," said Han Ying, Ph.D., CEO of Gyre Therapeutics. "The successful launch of avatrombopag and our growing commercial footprin ...

SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that the National Medical Products Administration (NMPA) of the People's Republic of China ("PRC") has approved its clinical trial application for a potential new indication for pirfenidone in oncology-related pulmonary complications. The trial will evaluate pirfenidone capsules for the treatment of radiation-induced lung inj ...