Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.

Status: Not yet recruiting

Phase of Trial: Phase III

Latest Information Update: 06 Mar 2026

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At a glance

06 Mar 2026 New trial record
03 Mar 2026 According to the Gyre Pharmaceuticals media release, pre-NDA meeting with the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) which supported a conditional approval and priority review eligibility filing for Hydronidone, subject to formal approval. As a result, company plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a Phase 3c confirmatory trial to support full approval in China.

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