As a category B drug, it has been included in the National Reimbursement Drug List (NRDL). With the level I medical evidence, it is the first anti-hepatic fibrosis therapeutic drug recommended in the Six Major Guidelines/Consensuses, and also the first Chinese patent drug for treatment of hepatopathy for which Phase II clinical trials have been completed in the United States upon approval by the FDA. Substantial clinical evidences show that Fuzhenghuayu has the efficacy of preventing and treating hepatic fibrosis and liver cirrhosis, and reducing the risk of liver cancer.