Overview

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.