07:49 AM EDT, 03/17/2026 (MT Newswires) -- Gyre Therapeutics ( GYRE ) said Tuesday that China's National Medical Products Administration has granted priority review for its experimental drug hydronidone for chronic hepatitis B-induced liver fibrosis.
The company said it plans to submit a formal new drug application through its majority-owned subsidiary, Gyre Pharmaceuticals.
Gyre said it has completed a phase 3 clinical trial of the investigational drug in China, which showed statistically significant fibrosis regression after 52 weeks of treatment, including in patients with early cirrhosis.
The priority review designation accelerates evaluation of new drugs with clinical value, it added.