SAN DIEGO, Oct. 01, 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 Han Ying, PhD, Chief Executive Officer, will be presenting a company overview at the 8th Annual H.C. Wainwright MASH Investor Conference on Monday, October 7, 2024, at 2:30 PM ET (11:30 AM PT). The live webcast will be available on the Events and Presentations ...

Core Insights - Gyre Therapeutics has received NMPA approval for avatrombopag maleate tablets for treating CLD-associated thrombocytopenia, expanding its rare disease product lines [1][3] - The company has also received IND approval for F230 to treat pulmonary arterial hypertension and plans to initiate a Phase 1 trial in 2025 [2][6] - Financial results for Q2 2024 show revenues of $25.2 million, a decrease from $29.3 million in Q2 2023, primarily due to normalized anti-fibrosis drug sales [8][10] Business Updates - Gyre Pharmaceuticals generated $25.1 million in sales of ETUARY for Q2 2024, supporting future revenue growth through the acquisition of rights to nintedanib [3] - The approval of avatrombopag provides a treatment option for a common hematologic complication in patients with CLD [3] - Gyre expects to report data from its Phase 3 trial of F351 in CHB-associated liver fibrosis by early 2025 [2][5] Clinical Development - F351 has shown promise in preclinical studies for treating liver fibrosis, with topline data from a Phase 3 trial expected by early 2025 [4][5] - Gyre plans to initiate a Phase 2a trial for F351 in MASH-associated liver fibrosis in 2025, pending FDA review [5][6] - Ongoing Phase 2 trial for F573 is assessing its safety and efficacy in treating acute liver failure [5] Financial Performance - As of June 30, 2024, Gyre had cash and cash equivalents of $16.1 million, with total revenues for the first half of 2024 at $52.4 million [8][10] - The company reported a net income of $4.5 million for Q2 2024, compared to $3.8 million in Q2 2023 [9][10] - General and administrative expenses increased to $3.4 million in Q2 2024, primarily due to costs associated with being a public company [9][10] Corporate Developments - David M. Epstein was appointed to Gyre's Board of Directors, bringing extensive pharmaceutical industry experience [7] - Gyre was added to the small-cap Russell 2000 and all-cap Russell 3000 Indexes in June 2024 [7]

SAN DIEGO, Aug. 09, 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 Han Ying, PhD, Chief Executive Officer, will be presenting a company overview at the Sidoti August Virtual Investor Conference on Thursday, August 15, 2024, at 10:45 a.m. ET (7:45 a.m. PT). To register in advance for the presentation webcast, sign up here. A we ...

Investment Rating - The report initiates coverage with a "Buy" rating for Gyre Therapeutics, indicating an expected relative price increase of over 15% in the next 6 to 12 months [35]. Core Insights - Gyre Therapeutics focuses on organ fibrosis, with a comprehensive pipeline targeting lung, liver, and kidney fibrosis-related diseases. The flagship product, Aisrui (pirfenidone), has shown consistent sales growth, contributing to stable cash flow and supporting ongoing R&D and expansion efforts [8][49]. - The organ fibrosis market is characterized by high mortality rates and a lack of effective treatment options, with significant patient populations for liver fibrosis (145.5 million), chronic kidney disease-related fibrosis (22.8 million), and lung fibrosis (3.5 million) projected by 2023 [11][12]. - The company is well-positioned in the market, with Aisrui maintaining a leading market share in the idiopathic pulmonary fibrosis (IPF) segment, accounting for 55.4% of the market in 2023 [24][32]. Summary by Sections Section 1: Company Overview - Gyre Therapeutics, formerly known as Beijing Kanti Pharmaceutical, was established in 2002 and specializes in organ fibrosis, integrating R&D, production, and sales [53]. - The company has successfully developed and commercialized Aisrui, the first approved drug for IPF in China, and is advancing F351 (hydroxyne) for chronic hepatitis B-related liver fibrosis, which has received breakthrough therapy designation [49][54]. Section 2: Market Potential - The organ fibrosis market presents a significant opportunity due to the high mortality associated with these diseases and the limited treatment options available. The report highlights the urgent need for effective therapies in this area [11][12]. - Aisrui's sales reached 790.3 million yuan in 2023, reflecting its strong market position and the potential for continued growth as the company expands its product offerings [23][24]. Section 3: Financial Projections - Revenue projections for Gyre Therapeutics are optimistic, with expected revenues of 1.012 billion yuan in 2024, 1.143 billion yuan in 2025, and 1.484 billion yuan in 2026. Net profits are projected to reach 214 million yuan, 301 million yuan, and 452 million yuan for the same years, respectively [35][62]. - The company is anticipated to achieve breakeven through the continued growth of Aisrui, with a strong pipeline of products that have high sales ceilings [49][50].

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].

Core Insights - Gyre Therapeutics has published findings indicating that hydronidone, a novel derivative of pirfenidone, shows promise in treating liver fibrosis by inducing apoptosis in activated hepatic stellate cells (HSCs) through the endoplasmic reticulum stress-associated mitochondrial apoptotic pathway [2][3] Company Overview - Gyre Therapeutics is a clinical-stage biotechnology company focused on developing anti-fibrotic therapeutics for chronic organ diseases, with its lead candidate being F351 (Hydronidone) for treating NASH-associated fibrosis in the U.S. [4] - The company is advancing a diverse pipeline in the People's Republic of China (PRC) through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions and other candidates [4] Research and Development - The recent study published in the Journal of Gastroenterology and Hepatology supports the potential of hydronidone as a therapy for liver fibrosis, demonstrating significant apoptosis in activated HSCs in both in vivo and in vitro models [2][3] - Gyre Pharmaceuticals is currently conducting a Phase 3 trial in the PRC for hydronidone's efficacy in treating Chronic Hepatitis B (CHB)-associated liver fibrosis, with topline data expected by early 2025 [7] - The trial involves 248 patients, aiming for a primary endpoint of reducing the liver fibrosis score by at least one grade after treatment with hydronidone in combination with entecavir [7]

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 ...