Core Viewpoint - Gyre Therapeutics, Inc. announced that its subsidiary in China, Gyre Pharmaceuticals, has completed a Pre-New Drug Application meeting with the Center for Drug Evaluation regarding Hydronidone, a first-in-class anti-fibrotic therapy for chronic hepatitis B-associated liver fibrosis [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) [4]. - The trial also met a key secondary endpoint by demonstrating improvement in liver inflammation without fibrosis progression and showed 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, supporting the potential conversion 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 final data readiness and regulatory procedures [5][10]. Group 4: Market Opportunity - 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].