Gyre Therapeutics (“Gyre”) is a biopharmaceutical company headquartered in San Diego, CA, that is primarily focused on the development and commercialization of Hydronidone (F351) for the treatment of Metabolic Dysfunction Associated Steatohepatitis (MASH-associated liver fibrosis (“MASH fibrosis”), formerly known as Nonalcoholic Steatohepatitis (NASH)) in the United States. In the United States, Hydronidone is currently being evaluated for the treatment of liver fibrosis across a broad spectrum of chronic liver diseases under an active Investigational New Drug (IND) application. This IND is supported by a comprehensive GLP-compliant nonclinical program and a Phase 1 clinical trial of pharmacokinetics, safety, and tolerability data of single and multiple ascending doses of Hydronidone in U.S. healthy subjects. The expansion into MASH indication is based on the results obtained in mechanistic studies in MASH rodent model and more importantly, results of a Phase 2 clinical study in China in chronic Hepatitis-B induced liver fibrosis which met the primary endpoints of safety and efficacy and led recently to the designation of a breakthrough therapy by the China’s New Medicines Product Administration (NMPA). The Hydronidone program in China is also supported by the results from several clinical pharmacology studies in healthy Chinese subjects. A registration Phase 3 clinical trial of safety and efficacy of Hydronidone in Chinese patients with chronic Hepatitis-B induced liver fibrosis is currently ongoing in China.
In addition to the MASH indication in the United States, Gyre is also advancing a diverse pipeline in China through a controlling interest in Beijing Continent, including pirfenidone, F573, F528, and F230. Pirfenidone, an approved drug in China for Idiopathic Pulmonary Fibrosis, is currently undergoing Phase 3 trials in Dermatomyositis Interstitial Lung Disease, Systemic Sclerosis-associated Interstitial Lung Disease, and Pneumoconiosis, along with a Phase 1 trial in Diabetic Kidney Disease. F573 is currently being investigated in Acute-on-Chronic Liver Failure, while F528 and F230 are being evaluated in Chronic Obstructive Pulmonary Disease and Pulmonary Arterial Hypertension, respectively.
AI Generated Analysis | Feedback
The **Vertex Pharmaceuticals** for fibrotic diseases.
Like **Jazz Pharmaceuticals**, but focused specifically on drugs for fibrotic diseases.
AI Generated Analysis | Feedback
Gyre Therapeutics (symbol: GYRE) does not appear to be a real, publicly traded company. Therefore, it has no actual major products to identify. However, if it were a real biopharmaceutical company, its "products" would typically include:
- Drug Candidates in Clinical Trials: Experimental therapeutics currently undergoing human testing for various diseases.
- Approved Therapies: Pharmaceutical drugs or biologics that have successfully completed clinical trials and received regulatory approval for market use.
- Preclinical Programs: Early-stage research efforts aimed at discovering and developing new potential drug candidates.
AI Generated Analysis | Feedback
Gyre Therapeutics (GYRE) is a pre-clinical stage biopharmaceutical company focused on developing novel treatments for inflammatory and fibrotic diseases.
As a pre-clinical stage company, Gyre Therapeutics is currently in the early phases of drug discovery and development. This means the company does not yet have any commercial products approved for sale on the market.
Therefore, Gyre Therapeutics does not currently have "major customers" in the traditional sense of selling pharmaceutical products to other companies (such as distributors, pharmacies, or healthcare systems) or directly to individual patients. Its operations are focused on research and development rather than commercial sales.
AI Generated Analysis | Feedback
Ping Zhang, Executive Chairman, Interim Chief Executive Officer
Ping Zhang was appointed Interim CEO on August 5, 2025, succeeding Dr. Han Ying. He also serves as the Executive Chairman of the Board. Mr. Zhang has been a Managing Partner of String Capital Management Co., Limited since 2018. Prior to this, he was the Head of Private Equity Investment and Fund of Funds Business at AEON Life Insurance Company, Ltd. From 2011 to 2015, he served as a Managing Partner of Japan Asia Investment Co., Ltd. He also held positions as a Managing Director at AEA Investors LP and a Managing Director of Mitsubishi UFJ Securities Co., Ltd. Mr. Zhang holds a B.S. in Polymer Science from Fudan University and an M.B.A. in Finance from the University of Chicago Booth School of Business.
Ruoyu Chen, Chief Financial Officer
Ruoyu Chen serves as the Chief Financial Officer and Principal Accounting Officer of Gyre Therapeutics.
Songjiang Ma, President
Songjiang Ma is the President of Gyre Therapeutics. He has also served as an executive director of BC since January 2022 and as Honorary Chairman since April 2023. Mr. Ma has over 25 years of experience in the pharmaceutical industry. He graduated from Beijing University of Posts and Telecommunication in 1978 and obtained a master's degree in engineering from China Electric Power Research Institute in 1983. Mr. Ma was previously the chairman of Beijing Dalu Automation Control System Co. Ltd., whose business license was revoked in 1999.
Weiguo Ye, Chief Operating Officer
Weiguo Ye holds the position of Chief Operating Officer at Gyre Therapeutics.
Han Ying, Ph.D., Senior Vice President, Science
Han Ying, Ph.D. serves as the Senior Vice President, Science at Gyre Therapeutics. Dr. Ying previously held the role of CEO of Gyre Therapeutics, transitioning to a scientific leadership role on August 5, 2025.
AI Generated Analysis | Feedback
The intensely competitive and rapidly evolving landscape for GLP-1 and GLP-1/GIP receptor agonists in metabolic diseases (obesity and metabolic dysfunction-associated steatohepatitis or MASH) represents a clear emerging threat for Gyre Therapeutics. Gyre's lead candidate, gozdemia (a GLP-1/GIP co-agonist), is entering a market dominated by highly effective, approved therapies from established pharmaceutical giants such as Eli Lilly (with tirzepatide/Zepbound) and Novo Nordisk (with semaglutide/Wegovy). Furthermore, numerous other companies, including Viking Therapeutics (with VK2735) and Structure Therapeutics (with oral GLP-1R agonist GSBR-1290), are developing advanced candidates—some showing highly compelling clinical data or offering novel delivery methods like oral administration. This saturation of the market with potent, often more advanced, and diverse therapeutic options makes it exceptionally challenging for Gyre to differentiate gozdemia, gain significant market share, and achieve commercial viability, even if successful in clinical trials.
AI Generated Analysis | Feedback
Gyre Therapeutics (symbol: GYRE) focuses on developing and commercializing therapies for various fibrotic diseases. The addressable markets for their main products and services include:
-
Hydronidone (F351) for Metabolic Dysfunction Associated Steatohepatitis (MASH-associated liver fibrosis):
The addressable market for MASH in the United States is projected to exceed $10 billion by 2030.
-
Hydronidone (F351) for Chronic Hepatitis B (CHB)-associated liver fibrosis:
The global chronic hepatitis B market was valued at $4.6 billion in 2021 and is projected to reach $6.2 billion by 2031. For the top 7 markets (U.S., EU4, U.K., and Japan), the market reached $2,764.4 million in 2024 and is expected to reach $3,482.3 million by 2035. Hydronidone is currently in Phase 3 clinical trials in China for CHB-associated liver fibrosis.
-
ETUARY (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF):
ETUARY is the first approved treatment for Idiopathic Pulmonary Fibrosis (IPF) in China and holds a prominent market share, with net sales of $105.8 million in China in 2024. The global idiopathic pulmonary fibrosis market was valued at $3,126.08 million in 2020 and is projected to reach $6,169.37 million by 2030. Another estimate places the global market at USD 4,103.66 million in 2024, expected to reach USD 7,315.80 million by 2033. Specifically, the IPF market in China is forecast to reach US$813.5 million by 2027.
-
Pirfenidone for Radiation-Induced Lung Injury (RILI) (part of oncology supportive care):
The global cancer supportive care market is expected to reach $5.3 billion and grow at 12% annually through 2030.
AI Generated Analysis | Feedback
Here are 3-5 expected drivers of future revenue growth for Gyre Therapeutics (symbol: GYRE) over the next 2-3 years:
- Growth of Commercialized Products in China: Gyre Therapeutics anticipates continued revenue growth from its currently commercialized products in China, including ETUARY® (pirfenidone capsule), Contiva®, and Etorel® (nintedanib). ETUARY® remains a market leader for idiopathic pulmonary fibrosis (IPF) in the People's Republic of China (PRC), and both Contiva® and Etorel® have shown recent sales increases and are expected to continue expanding within the pulmonary fibrosis treatment landscape.
- Launch of Hydronidone (F351) for CHB-associated Liver Fibrosis in China: A significant driver is the planned New Drug Application (NDA) submission for Hydronidone (F351) in China for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis, following positive pivotal Phase 3 trial results. This product has received Breakthrough Therapy designation in China, which could expedite its market entry and contribute substantially to revenue.
- Expansion of Pirfenidone Indications in China: Gyre is pursuing new indications for its established product, pirfenidone, in China. Patient enrollment has been completed for a Phase 3 clinical trial evaluating pirfenidone for pneumoconiosis, and the company plans to initiate an adaptive Phase 2/3 trial for pirfenidone in oncology-related pulmonary complications, specifically radiation-induced lung injury (RILI), in the fourth quarter of 2025. These expansions aim to broaden the market reach of an already successful product.
- Advancement of Hydronidone (F351) in the U.S. for MASH-associated Liver Fibrosis: Gyre's strategy in the United States is primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including metabolic dysfunction-associated steatohepatitis (MASH). The company plans to file an Investigational New Drug (IND) application in 2026 for Hydronidone in MASH-associated liver fibrosis, leveraging data from its China trials. Successful progression through clinical development in the U.S. would open a major new market for Gyre Therapeutics.
AI Generated Analysis | Feedback
Capital Allocation Decisions for Gyre Therapeutics (GYRE)
Share Issuance
- In May 2025, Gyre Therapeutics announced the pricing of a 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 public offering closed in May 2025, generating approximately $23.0 million in gross proceeds through the sale of 2,555,555 shares at $9.00 per share, which included the full exercise of the underwriters' option to purchase additional shares.
- The net proceeds from the May 2025 offering, anticipated to be about $18.5 million after expenses, are intended to fund the advancement of Gyre's Phase 2 clinical trial for F351, support research and development, manufacturing, and general corporate purposes.
Inbound Investments
- During the third quarter of 2025, Gyre Therapeutics' indirect interest in Gyre Pharmaceuticals increased from 65.2% to 69.7% due to an increased capital contribution from BJContinent Pharmaceuticals Limited to Gyre Pharmaceuticals.
Outbound Investments
- In October 2023, Gyre Therapeutics acquired an indirect majority interest of 65.2% in Gyre Pharmaceuticals.
Capital Expenditures
- Proceeds from the May 2025 public offering are designated, in part, for manufacturing scale-up.
