Gyre Therapeutics Appoints Dr. Dan Weng to Its Board of Directors
Appointment of Dr. Dan Weng: Gyre Therapeutics announced the appointment of Dr. Dan Weng to its Board of Directors, effective August 18, 2025. Dr. Weng brings extensive experience in managing global clinical trials and has held leadership roles in various contract research organizations.
Gyre's Focus on Fibrosis Therapies: Gyre Therapeutics is dedicated to developing fibrosis-first therapies for chronic diseases affecting multiple organ systems, with a strong emphasis on innovative drug development and commercialization.
Flagship Product and Pipeline: The company's flagship product, ETUARY® (Pirfenidone capsule), has been successful in the market since its approval in 2011, while their pipeline includes promising treatments like Hydronidone for liver fibrosis, which is expected to file for NDA in Q3 2025.
Strategic Growth Plans: With Dr. Weng's strategic insight and regulatory experience, Gyre aims to expand its commercial reach and advance its multinational pipeline, including ongoing developments for various conditions such as PD, DKD, and COPD.
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Gyre Pharmaceuticals Reaches Pre-NDA Consensus with China's CDE for Hydronidone Approval
- Clear Regulatory Pathway: Gyre Pharmaceuticals has reached consensus with China's CDE that existing Phase 3 clinical data supports a conditional approval filing for Hydronidone, with plans to submit an NDA in the first half of 2026, marking a significant advancement in the anti-fibrotic treatment landscape.
- Clinical Data Validation: In the Phase 3 trial, Hydronidone demonstrated that 52.85% of patients achieved ≥1-stage fibrosis regression at Week 52, significantly outperforming the placebo group's 29.84% (p=0.0002), establishing a strong foundation for its market potential.
- Priority Review Eligibility: The CDE confirmed that Hydronidone meets the criteria for inclusion in China's Priority Review Program for Innovative Drugs, which is expected to expedite the approval process, enabling the company to quickly capture market share and address urgent patient needs.
- Follow-up Clinical Trial Plans: The company plans to conduct an additional confirmatory clinical trial (Phase 3c) to support the transition from conditional approval to full approval, further solidifying its position in the Chinese market.









