Products/Pipeline
F351
Drug description
Small molecule compound for liver fibrosis
Purpose of use
In Asian countries, including Japan and China, hepatitis B virus (HBV) and hepatitis C virus (HCV) infections are the primary causes of liver cirrhosis. F351, a novel compound developed by GNI Group’s subsidiary Shanghai Genomics Co., Ltd., has demonstrated effectiveness in preventing or treating liver fibrosis and cirrhosis based on non-clinical studies and clinical trials. Liver disease is considered a “national affliction” in China. Chronic viral hepatitis can lead to liver fibrosis, which, without proper intervention, may progressively worsen over time and potentially result in death.
Clinical Development
Safety, pharmacological, and toxicity tests for F351 are being conducted in China.
Based on the results of these non-clinical trials, an Investigational New Drug (IND) application was filed in December 2006. Following the Phase 1 clinical trial that began in December 2007, the Phase 1b clinical trial was completed in June 2014.
Subsequently, in preparation for the Phase 2 clinical trial, a Phase 2 clinical trial application was submitted in June 2013, and permission to conduct Phase 2 clinical trials was obtained in July 2014, and Phase 2 clinical trials were started in June 2015, completed in August 2020, and Phase 3 clinical trials were started in January 2021. Target subject enrollment for Phase 3 clinical trials is scheduled to be completed in October 2023, and top-line data from Phase 3 clinical trials is expected to be available at the end of 2024 or early 2025.
Notably, the National Medical Products Administration of China designated F351 as a “breakthrough therapeutic drug” in March 2021.
Furthermore, we have conducted various animal experiments to confirm the effectiveness of F351 for renal fibrosis, which is similar to liver fibrosis. These experiments have shown that F351 demonstrates excellent characteristics against renal fibrosis as well, and it is expected to become a promising new drug in the future.