Ganley Pharmaceuticals has submitted an application for a U.S. clinical trial of NASH's new drug ASC42

Pharmaceutical Co., Ltd. today announced that it has submitted a clinical trial application (IND) for the non-alcoholic fatty hepatitis (NASH) candidate drug ASC42 to the FDA. Ganlai Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Goliath Pharmaceutical Co., Ltd.ASC42 is an in-house development of The Vaniol X-intra-drug (FXR) astigation agent. In two NASH animal models, ASC42 showed significant improvements in liver fatty degeneration, inflammation and fibrosis.Ganley Pharmaceuticals also has two clinically-staged candidates in its NASH pipeline, ASC40 and ASC41, respectively. AsC42 can be used alone or in federation with ASC40 or ASC41.ASC40 is an oral fatty acid synthase (FASN) inhibitor. In this randomized, placebo-controlled Phase II clinical study (FASCINATE-1), clinical researchers assessed the safety and effectiveity of ASC40 (TVB-2640) in 99 U.S. NASH patients, given once a day for 12 weeks. Preliminary clinical data show that ASC40 (TVB-2640) significantly reduced liver fat content (the main therapeutic endpoint of the trial) and had a response rate of 61% in the 50 mg dose group. In addition, the subjects showed improvements in liver function and fibrosis indicators. ASC40 (TVB-2640) II. Phase (AGEE-1) data are released as the latest results (Late Breaker) at the European Society of Hepatology (EASL) International Hepatology 2020 Annual Meeting (ILC) held online August 28, 2020.ASC41 is an oral thyroid hormone-infested (THR-thyroid) agitant whose NASH adaptation clinical trial application was recently approved by China's State Drug Administration. Topline Data (Topline Data) is expected to be available by the end of 2020 for phase I. safety, drug generation and preliminary efficacy (LDL-C) among healthy volunteers with LDL-C greater than 110 mg/dL.“ We are pleased to have submitted our clinical trial application for ASC42, an in-house FXR agonist that is expected to be best-in-class," said Dr. He Wei, Chief Scientific Officer of Goliath.about NASH NASH is a developing form of non-alcoholic fatty liver disease (NAFLD), characterized by fat build-up, inflammation and fibrosis (scarring) in the liver, which can eventually lead to cirrhosis and liver failure. NASH is the leading cause of liver disease worldwide and the leading cause of liver transplantation in people under 50 years of age in the United States. There is currently no approved treatment for NASH.About Goliathis an innovative research and development-driven biotechnology company listed on the Hong Kong Stock Exchange (Goliath Pharmaceuticals, 1672.HK). Goli is committed to the development and commercialization of viral hepatitis, fatty hepatitis and AIDS diseases to meet the clinical needs of patients at home and abroad. Led by a management team with deep expertise and outstanding past achievements, Goliath has developed into an integrated platform company, covering a complete value chain from the discovery and development of new drugs to production and commercialization. Goliath currently has three commercial products and eleven in-house research products (seven of which are in-house). 1, viral hepatitis (Viral Hepatitis): Goliath focus on Gonovir ®/Xinlilai® full oral hepatitis C treatment program commercial promotion; Goli focuses on the commercialization of Pirohim® for the clinical cure of slow hepatitis B, and the injection of PD-L1 antibody ASC22 under Paroxin ® and subsurfic injections as the cornerstone drug, in cooperation with other target drugs, is expected to bring more significant breakthroughs to the clinical cure of hepatitis B. 2. Non-alcoholic fatty hepatitis (NASH): Goliath's three NASH candidate drugs target three different targets: fatty acid synthesis enzyme (FASN), thyroid hormone-like hormone digester (THR-s) and Faniol X-subject (FXR), which are expected to be used alone or in combination for the treatment of NASH. NASH is a global disease, and Goliath conducts global clinical research in Europe, America and China. 3. AIDS (HIV/AIDS): ASC09F is a protease fixed-dose compound inhibitor for the treatment of HIV, and the application for clinical trial of ASC09F has been approved. (Corporate website)