Japanese GNI Group announced that a China Phase II clinical study on F35 1 (hydroquinone) in the treatment of hepatitis B-related liver fibrosis achieved positive results in the primary end point analysis.

This is a randomized, double-blind, placebo-controlled, multi-center, dose-increasing study to evaluate the efficacy and safety of F35 1 in the treatment of liver fibrosis in patients with chronic hepatitis B in China.

In this study, 168 patients were randomly divided into four dose increasing groups: placebo, 60mg /TID (three times a day), 90mg /TID and120mg /TID.

The main end point of the study was that according to the pathological analysis of liver biopsy, the liver fibrosis score (using Ishak scoring system) decreased by one level before and after F35 1 treatment. Secondary end points include the decrease of HBV DNA titer, the decrease of kpa score of liver fiber scanning, the decrease of liver inflammation score and the improvement of ALT level.

During the 52-week treatment period, compared with placebo, the Ishak score of 90 mg /TID(270 mg/day) treatment group improved the best.

In this study, F35 1 was generally well tolerated. The incidence of adverse events of patients with special concern in placebo group, F35 1 60mg/TID group, 90mg/TID group and 120mg/TID group were 1 1.63%, 4.76% and 7./respectively. The incidence of gastrointestinal events were 23.26%, 265,438 0.43%, 65,438 0.67% and 65,438 0.565438 0% respectively. The incidence of serious adverse events was 4.65%, 2.38%, 2.38% and 7.32% respectively.

More detailed results and final report of this study will be published in future medical conferences and/or medical journals.

In China, F35 1 was awarded the status of major innovative drug, which provided a fast track for GNI Group's regulatory review and potential faster approval.

GN Group, which develops drugs to treat fibrosis, held a financial performance briefing for the second quarter of 2020 on August 18, 2020. Dean Luo Ying said that according to the remarkable effect of anti-hepatic fibrosis drug F35 1 in phase II clinical trial. It is reasonable to launch this product as early as 202 1.