Core Viewpoint - Gyre Therapeutics, Inc. announced that its subsidiary in China, Gyre Pharmaceuticals, completed a Pre-New Drug Application meeting with the Center for Drug Evaluation regarding Hydronidone, an anti-fibrotic therapy for chronic hepatitis B-associated liver fibrosis, indicating a positive regulatory pathway towards conditional approval in China [1][10]. Group 1: Regulatory Progress - Gyre Pharmaceuticals and the CDE reached a consensus that existing Phase 3 clinical data for Hydronidone support a conditional approval NDA submission for treating chronic hepatitis B-associated liver fibrosis, including early cirrhosis [2][10]. - The CDE indicated that Hydronidone qualifies for inclusion in China's Priority Review and Approval Program for Innovative Drugs, pending formal filing and regulatory review [2][10]. - Hydronidone received Breakthrough Therapy Designation from the NMPA in March 2021, recognizing its potential to address a serious condition with significant unmet medical need [3]. Group 2: Clinical Trial Results - Gyre reported that in its Phase 3 trial, 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52, compared to 29.84% in the placebo group (p=0.0002), demonstrating the drug's efficacy [4]. - The trial also met a key secondary endpoint by showing improvement in liver inflammation without fibrosis progression and exhibited a favorable safety profile [4]. Group 3: Future Plans - The company plans to conduct an additional confirmatory Phase 3c trial in China to evaluate liver-related clinical outcomes, which will support the transition from conditional approval to regular approval [5]. - Gyre expects to submit an NDA for conditional approval of Hydronidone in the first half of 2026, subject to data readiness and regulatory procedures [5][10]. Group 4: Market Need - Chronic hepatitis B-associated liver fibrosis represents a significant unmet medical need in China, with an estimated 60–70 million people infected with hepatitis B virus, and approximately 2.6 million diagnosed with clinically significant liver fibrosis [11]. Group 5: Company Overview - Gyre Pharmaceuticals is focused on developing innovative drugs for organ fibrosis, with Hydronidone being a structural analogue of pirfenidone, which has shown significant fibrosis regression in clinical trials [12]. - The company also has a pipeline that includes treatments for various conditions, and as of Q3 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals [12].

Company Overview - Gyre Therapeutics is a biopharmaceutical company based in San Diego, CA, focused on developing and commercializing Hydronidone for liver fibrosis, including MASH, in the United States [3] - The company leverages its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis [3] - In China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, which includes therapeutic expansions of ETUARY and development programs for F573, F528, and F230 [3] Upcoming Events - Management will present at the H.C. Wainwright 27 Annual Global Investment Conference on September 10, 2025, at 12:30 p.m. ET [1] - A live webcast of the presentation will be available on Gyre's website, with a replay accessible after the live session [2]

Core Viewpoint - Gyre Therapeutics has successfully completed a public offering of 2,555,555 shares at a price of $9.00 per share, raising approximately $23.0 million in gross proceeds to advance its clinical trials and operations [1][3]. Group 1: Offering Details - The public offering included the full exercise of an option by underwriters to purchase an additional 333,333 shares [1]. - Jefferies acted as the lead book-running manager, while H.C. Wainwright & Co. served as co-manager for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance Gyre's Phase 2 clinical trial of F351 for MASH-associated liver fibrosis, along with funding for research and development, manufacturing scale-up, and general corporate purposes [3]. Group 3: Company Overview - Gyre Therapeutics is focused on developing and commercializing therapies for liver fibrosis, particularly targeting MASH in the U.S. market [6]. - The company leverages its experience in mechanistic studies and clinical trials related to liver fibrosis [6].

Core Viewpoint - Gyre Therapeutics has announced a public offering of 2,222,222 shares at a price of $9.00 per share, aiming to raise approximately $20 million to support its clinical trials and operational needs [1][3]. Group 1: Offering Details - The public offering consists of 2,222,222 shares priced at $9.00 each, with an option for underwriters to purchase an additional 333,333 shares [1]. - The gross proceeds from the offering are expected to be around $20 million before deducting underwriting discounts and commissions [1]. - The offering is anticipated to close on or about May 27, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - Gyre plans to utilize the net proceeds from the offering, along with existing cash and cash flows, to advance its Phase 2 clinical trial of F351 for liver fibrosis associated with metabolic dysfunction [3]. - The funds will also be allocated for research and development, manufacturing scale-up, working capital, and general corporate purposes [3]. Group 3: Company Background - Gyre Therapeutics is a biotechnology company based in San Diego, focusing on organ fibrosis, particularly liver fibrosis related to metabolic dysfunction [6]. - The company is advancing a pipeline in China through its indirect controlling interest in Gyre Pharmaceuticals, which includes various therapeutic developments [6].

Core Viewpoint - Gyre Therapeutics has initiated an underwritten public offering of its common stock to fund its clinical trials and operational needs [1][2]. Group 1: Offering Details - Gyre is granting underwriters a 30-day option to purchase additional shares at the public offering price, subject to market conditions [1]. - The offering is made under a shelf registration statement effective since November 22, 2024, and will be conducted via a prospectus [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance Gyre's Phase 2 clinical trial of F351 for MASH-associated liver fibrosis, along with funding for research, development, manufacturing, and general corporate purposes [2]. Group 3: Management of the Offering - Jefferies is the lead book-running manager for the offering, with H.C. Wainwright & Co. serving as co-manager [3]. Group 4: Company Overview - Gyre Therapeutics is focused on developing and commercializing treatments for liver fibrosis, including MASH, and has a pipeline that includes various therapeutic programs in the U.S. and China [6].