GNI Group (TYO:2160) said its investigational drug F351 has been accepted for regulatory review in China, marking a key step toward potential approval for treating liver fibrosis linked to chronic hepatitis B, according to a Wednesday filing on the Tokyo Stock Exchange.
The application, submitted through its China-based subsidiary Gyre Therapeutics, has moved into substantive evaluation by China's drug regulator following validation of the filing.
F351, also known as hydronidone, has been granted priority review status by China's National Medical Products Administration, a designation that can shorten assessment timelines for therapies with significant clinical value.
The treatment targets liver fibrosis caused by chronic hepatitis B, a major health burden in Asia that can progress to cirrhosis and liver cancer if untreated, with limited existing therapeutic options.