Gyre Therapeutics recently completed a crucial Pre-NDA meeting with China's Center for Drug Evaluation (CDE) to establish the approval pathway and potential eligibility for priority review for Hydronidone.
The Phase 3 clinical data supporting the conditional approval filing for Hydronidone specifically in chronic hepatitis B (CHB)-associated liver fibrosis signifies a significant milestone in Gyre's regulatory strategy.
The company aims to submit a New Drug Application (NDA) in the first half of 2026, accompanied by a confirmatory clinical trial to secure full approval for Hydronidone in China.
Conditional Approval Pathway
Gyre Therapeutics has secured an agreement with China's CDE, indicating the submission will be based on the robust Phase 3 clinical data, streamlining the approval process for Hydronidone in CHB-associated liver fibrosis.
Priority Review Eligibility
Hydronidone has met the criteria for China's Priority Review Program, positioning it for expedited assessment and potential market entry, enhancing the drug's commercial prospects.
Breakthrough Therapy Designation
The previous designation awarded to Hydronidone in March 2021 not only validates its therapeutic potential but also paves the way for priority review, underscoring the drug's strategic significance.
Phase 3 Trial Results
Positive outcomes from the Phase 3 trial demonstrate Hydronidone's efficacy in inducing fibrosis regression and its favorable safety profile, bolstering confidence in its clinical utility and market adoption.
Hydronidone Overview
As a novel anti-fibrotic agent targeting specific liver fibrosis pathways, Hydronidone represents a promising therapeutic option for patients with CHB-associated liver fibrosis, addressing a critical unmet medical need in this patient population.
- Hydronidone's development addresses a substantial unmet medical necessity in the treatment landscape of CHB-associated liver fibrosis, positioning Gyre Therapeutics as a key player in this therapeutic area with significant growth potential.
- The strategic alignment with China's CDE not only reinforces Gyre's regulatory strategy but also enhances the likelihood of securing conditional approval for Hydronidone in the Chinese market, facilitating market access and revenue generation.
Gyre Therapeutics' collaboration with China's CDE signifies a pivotal advancement in the approval trajectory of Hydronidone, a breakthrough drug addressing the critical medical need in CHB-associated liver fibrosis. The positive Phase 3 trial outcomes and regulatory endorsements underscore the drug's potential for market penetration and growth in the fibrotic disease segment.