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A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2026

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At a glance

  • Drugs Hydronidone (Primary)
  • Indications Hepatic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Beijing Continent Pharmaceutical

Most Recent Events

  • 05 Jan 2026 According to a Gyre Therapeutics media release, 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.
  • 05 Jan 2026 According to a Gyre Therapeutics media release, the company has completed a Pre-New Drug Application (Pre-NDA) meeting with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) regarding Hydronidone. The CDE agreed that the existing Phase 3 clinical data support a conditional approval filing and priority review eligibility for Hydronidone, pending formal approval.
  • 07 Nov 2025 According to Gyre Therapeutics media release, Building on the positive Phase 3 trial results, Gyre Pharmaceuticals is actively engaging with China's National Medical Products Administration (NMPA) to confirm Priority Review eligibility for Hydronidone's New Drug Application (NDA).

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