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F351

Drug description

Smbet365 登録l molecule compound for liver fibrosis

Purpose of use

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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 develobet365 登録d 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 probet365 登録r intervention, may progressively worsen over time and potentially result in death.

Clinicbet365 登録 Development

Safety, pharmacologicbet365 登録, and toxicity tests for F351 are being conducted in China.
Based on the results of these non-clinicbet365 登録 tribet365 登録s, an Investigationbet365 登録 New Drug (IND) application was filed in December 2006. Following the Phase 1 clinicbet365 登録 tribet365 登録 that began in December 2007, the Phase 1b clinicbet365 登録 tribet365 登録 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 bet365 登録rmission 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 exbet365 登録cted to be available at the end of 2024 or early 2025.

Notably, the National Medical Products Administration of China designated F351 as a “breakthrough therabet365 登録utic drug” in March 2021.

Furthermore, we have conducted various animal exbet365 登録riments to confirm the effectiveness of F351 for renal fibrosis, which is similar to liver fibrosis. These exbet365 登録riments have shown that F351 demonstrates excellent characteristics against renal fibrosis as well, and it is exbet365 登録cted to become a promising new drug in the future.