SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics ("Gyre") (NASDAQ:GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial" in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the year ended December 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 Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 12770 High Bluff Drive Suite 150 San Diego ...

Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025 Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025 Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025 Full year 2025 total revenue guidance of $118 to $128 million SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a se ...

Company Overview - Gyre Therapeutics is a self-sustainable, commercial-stage biotechnology company focused on chronic organ diseases, headquartered in San Diego, CA [1][3] - The company is developing F351 (Hydronidone) for MASH-associated fibrosis in the U.S. and has a diverse pipeline in the PRC through its subsidiary Gyre Pharmaceuticals [3][4] Leadership Changes - Ping Zhang has been appointed as the lead independent director of the Board and a member of the Nominating and Corporate Governance Committee [1] - Ying Luo, Ph.D., resigned as Chairman of the Board to focus on other responsibilities at GNI Group Ltd, with Songjiang Ma appointed as the new Chairman of Gyre Pharmaceuticals [1][3] Financial Performance - Gyre Pharmaceuticals, a subsidiary of Gyre Therapeutics, reported net sales of $112.1 million in 2023 for its flagship product ETUARY® [4] - F351 is currently in a Phase 3 clinical trial for CHB-associated liver fibrosis in the PRC, with topline data expected by early 2025 [4] Product Development - Gyre Therapeutics is advancing F351 based on mechanistic studies and clinical studies related to MASH and CHB-induced liver fibrosis [3] - The company is also developing treatments for other conditions such as COPD, PAH, and ALF/ACLF [4]

Last patient completed pivotal Phase 3 trial in CHB-associated liver fibrosis in the PRC with data expected in Q1 2025 On track to initiate U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025 Commercial launch of avatrombopag maleate tablets expected by the first half of 2025 Commercial launch of nintedanib expected in 2025 Cash and cash equivalents totaled $15.9 million as of September 30, 2024 SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-s ...

Revenue Performance - Gyre Therapeutics reported revenues of $25.5 million for Q3 2024, a decrease of 20.3% from $32.0 million in Q3 2023, primarily due to a $6.4 million drop in anti-fibrosis drug sales[12]. - For the nine months ended September 30, 2024, total revenue was $77.9 million, down 9.7% from $86.3 million in the same period in 2023, driven by an $8.0 million decrease in anti-fibrosis drug sales[14]. - For the three months ended September 30, 2024, Gyre's revenues were $25.5 million, a decrease of 20.5% compared to $32.0 million for the same period in 2023[21]. - Gyre Pharmaceuticals reported net sales of $112.1 million for ETUARY® in 2023, maintaining a significant market share in the PRC[17]. Income and Expenses - Net income for Q3 2024 was $2.9 million, compared to $7.5 million in Q3 2023, reflecting a significant decrease[14]. - Selling and marketing expenses for Q3 2024 were $13.7 million, slightly down from $13.9 million in Q3 2023[12]. - General and administrative expenses increased to $3.8 million in Q3 2024 from $1.2 million in Q3 2023, primarily due to costs associated with being a public company[12]. - Total operating expenses for the three months ended September 30, 2024, were $21.3 million, an increase of 10.3% from $19.3 million in the same period last year[21]. - Gyre's net income for the three months ended September 30, 2024, was $2.9 million, down 61.9% from $7.5 million in the prior year[21]. - Non-GAAP adjusted net income for the nine months ended September 30, 2024, was $15,737,000, compared to $23,313,000 for the same period in 2023, reflecting a decline of about 32.5%[26]. - Non-GAAP adjusted net income for the three months ended September 30, 2024, was $4,395,000, down from $11,188,000 in the same period of 2023, a decrease of about 60.7%[26]. - The company reported a significant decrease in net income for the nine months ended September 30, 2024, compared to the previous year, indicating potential challenges in revenue generation[26]. Cash Position - Cash and cash equivalents stood at $15.9 million as of September 30, 2024, expected to fund operations for at least the next 12 months[12]. - The company has a cash and cash equivalents balance of $15.9 million as of September 30, 2024, down from $33.5 million at the end of 2023[23]. Clinical Trials and Product Development - The pivotal Phase 3 trial for F351 in CHB-associated liver fibrosis was completed with 248 patients, and topline results are expected in Q1 2025[1]. - Gyre plans to initiate a U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis in 2025[1]. - The commercial launch of avatrombopag maleate tablets is anticipated in the first half of 2025, expanding Gyre's rare disease product lines[3]. - Gyre is advancing F351 in a Phase 3 clinical trial for CHB-associated liver fibrosis, with topline data expected by early 2025[17]. - The company anticipates the U.S. IND submission of F351 for MASH-associated liver fibrosis and the initiation of a Phase 2 trial in the near future[19]. - The company is also developing treatments for COPD, PAH, and ALF/ACLF, indicating a diverse pipeline[17]. Financial Adjustments and Strategy - The loss from the change in fair value of warrants for the nine months ended September 30, 2024, was $(6,973,000), compared to no gain or loss in the same period of 2023[26]. - Provision for income taxes for the three months ended September 30, 2024, was $1,074,000, down from $3,678,000 in the same period of 2023, a decrease of approximately 70.8%[26]. - The adjustments for fair value of warrants were based on the Black-Scholes option pricing model, reflecting the company's financial strategy[26]. - The financial results indicate a need for the company to reassess its operational strategies to improve profitability moving forward[26]. - Overall, the financial performance shows a trend of declining income and increased tax provisions, which may impact future investment decisions[26].

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].