Gyre Therapeutics Communicates Hydronidone Application with China's Drug Administration
Gyre Therapeutics announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Co., Ltd., completed a Pre-New Drug Application communication meeting with the Center for Drug Evaluation of China's National Medical Products Administration regarding Hydronidone, the company's first-in-class anti-fibrotic therapy. During the meeting, Gyre Pharmaceuticals and the CDE reached consensus that existing Phase 3 clinical data for Hydronidone, based on histologic improvement in liver fibrosis as measured by the Ishak fibrosis score, are generally supportive of submission of a conditional approval NDA for the treatment of chronic hepatitis B-associated liver fibrosis, including early cirrhosis. The CDE further indicated that Hydronidone meets the criteria for inclusion in China's Priority Review and Approval Program for Innovative Drugs, subject to formal filing, acceptance and regulatory review. The NMPA previously granted Hydronidone Breakthrough Therapy Designation in March 2021, recognizing its potential to address a serious condition with significant unmet medical need. This designation supports eligibility for priority review, which is intended to facilitate an accelerated regulatory review process for innovative therapies. As part of the agreed regulatory pathway, the company plans to conduct an additional confirmatory clinical trial, referred to as a Phase 3c trial in China, designed to evaluate liver-related clinical outcomes to support potential conversion from conditional approval to regular approval. The company currently expects to submit an NDA for conditional approval of Hydronidone in the first half of 2026, subject to final data readiness and applicable regulatory procedures.
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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.
