SAN DIEGO, July 02, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), a selfsustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia ("TP") associated with chronic liver disease ("CLD") in adu ...

Forward-Looking Statements Gyre Pharmaceuticals acquired avatrombopag under a transfer agreement with Nanjing Healthnice Pharmaceutical Technology Co., Ltd. ("Nanjing Healthnice") in June 2021. Avatrombopag is an oral thrombopoietin receptor agonist ("TPO-RA"). Avatrombopag was approved by the U.S. Food and Drug Administration ("FDA") for the treatment of adults with CLD-associated TP in May 2018, and its indication was subsequently expanded to include the treatment of immune thrombocytopenia in June 2019. ...

Core Viewpoint - Gyre Therapeutics has published promising research on hydronidone, a novel derivative of pirfenidone, indicating its potential as a therapy for liver fibrosis through the induction of apoptosis in activated hepatic stellate cells [1][5]. Company Overview - Gyre Therapeutics is a clinical-stage biotechnology company focused on developing anti-fibrotic therapeutics for chronic organ diseases, particularly liver fibrosis [1][3]. - The company is headquartered in San Diego, CA, and is advancing a diverse pipeline, including F351 (Hydronidone) and other therapeutic candidates [3]. Research Findings - The study published in the Journal of Gastroenterology and Hepatology demonstrated that hydronidone significantly promotes apoptosis in activated hepatic stellate cells (aHSCs) in both in vivo and in vitro models [2][5]. - Mechanistic studies revealed that hydronidone triggers endoplasmic reticulum stress (ERS) and activates the IRE1α-ASK1-JNK pathway, leading to mitochondrial dysfunction and apoptosis of aHSCs [2][5]. Clinical Development - Gyre is currently evaluating hydronidone in a Phase 3 trial for Chronic Hepatitis B (CHB)-associated liver fibrosis in the People's Republic of China, with topline data expected by early 2025 [6]. - The trial involves 248 patients and aims to reduce the liver fibrosis score by at least one grade after treatment with hydronidone in combination with entecavir [6]. - Following the Phase 3 trial, Gyre plans to initiate a Phase 2a proof-of-concept trial for NASH-associated liver fibrosis in 2025 [6].

"Preclinical animal studies have shown that treatment with hydronidone attenuated liver fibrosis by inhibiting the activation of hepatic stellate cells (HSCs), although the underlying mechanisms of action are still not fully understood," said Han Ying, Ph.D., CEO of Gyre. "The findings of these in vivo and in vitro studies demonstrate that hydronidone induces apoptosis in activated HSCs (aHSCs) via the endoplasmic reticulum stress (ERS)-associated mitochondrial apoptotic pathway and suggest that hydronidone ...

SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced that the Center for Drug Evaluation ("CDE") of China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) Investigational New Drug ("IND") application for F230 tablets, a selective endothelin recep ...

SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced that the Center for Drug Evaluation ("CDE") of China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) Investigational New Drug ("IND") application for F230 tablets, a selective endothelin recept ...

Company Overview - Gyre Therapeutics is a clinical-stage biotechnology company focused on developing anti-fibrotic therapeutics for chronic organ diseases [1][4] - The company is headquartered in San Diego, CA, and is advancing its lead product F351 (Hydronidone) for the treatment of NASH-associated fibrosis in the U.S. [4] Recent Developments - Gyre Therapeutics is expected to be added to the small-cap Russell 2000® and all-cap Russell 3000® Indexes effective after U.S. market close on June 28, 2024 [1][2] - The addition to the Russell Indexes is seen as a significant milestone for the company, enhancing its visibility as it advances its product F351 in both the PRC and the United States [2] Market Context - The Russell Indexes capture the 4,000 largest U.S. stocks as of April 30, 2024, ranked by total market capitalization [2] - Approximately $12.1 trillion in assets are benchmarked against the Russell U.S. Indexes, indicating the importance of these indexes for investment managers and institutional investors [3]

SAN DIEGO, May 28, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced that it expects to be added to the small-cap Russell 2000® and all-cap Russell 3000® Indexes at the conclusion of the 2024 Russell Indexes annual reconstitution, effective after U.S. market close on June 28, 2024, according to a preliminary list of additions posted on May ...

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, 2024 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 ...

Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC remains on track with data anticipated by early 2025 U.S. IND submission to evaluate F351 for the treatment of NASH-associated liver fibrosis expected in late 2024; Phase 2a trial expected to initiate in 2025 Acquired the rights to complementary assets relating to nintedanib through Gyre Pharmaceuticals to improve competitiveness in the PRC Cash and cash equivalents totaled $29.8 million as of March 31, 2024 ...