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].
Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting