Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. announces today that it received investigational new drug application (IND) approval from FDA for its drug candidate ASC42, to conduct clinical trials for non-alcoholic steatohepatitis (NASH) indication.

ASC42 is an in-house developed，novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis. ASC42 is an oral tablet formulation developed with proprietary therapy and is stable at room temperature.

Gannex has two additional drug candidates at clinical stage in its NASH pipeline, ASC40 and ASC41. ASC40(TVB-2640), an oral fatty acid synthase (FASN) inhibitor, has been shown to significantly reduce liver fat with a 61% responder rate in the 50 mg group in Phase II clinical trial (FASCINATE-1). ASC41 is a liver-targeted prodrug and its active moiety (ASC41-A) is selective for THR-β. ASC42 is expected to be used alone or in combination with ASC40 or ASC41.

"We are delighted that the FDA has cleared ASC42 IND for NASH, an increasingly prevalent disease for which there are currently no approved therapies," said Dr. Handan He, Chief Scientific Officer of Ascletis, "This is an important milestone that allows us to commence our clinical trials this year. We will continue our commitment to patient-centric innovation and develop new medicines to address the unmet needs in NASH treatment."

About NASH

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver, inflammation and fibrosis (scarring), and can eventually lead to cirrhosis and liver failure. NASH is a major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US. There are currently no approved treatments for NASH.

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong, S.A.R., China Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs of viral hepatitis, NASH and HIV/AIDS, for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis has three marketed products and eleven R&D pipeline drug candidates (seven of them developed in house). 1. Viral hepatitis: (i) marketed all oral HCV regimen of Asclevir? and Ganovo? combination (RDV/DNV regimen) and ASC18 fixed dose combination (FDC), with bridging study finished, is an upgraded version of RDV/DNV regimen. ASC18FDC will further enhance the competitiveness of Ascletis ' hepatitis C products. (ii) marketed Pegasys? for HBV clinical cure; (iii) breakthrough therapies for HBV clinical cure. 2. NASH: global development of novel drug candidates against three different targets – FASN, THR-beta and FXR, which are expected to be used alone or in combination. NASH is a global disease, Ascletis conducts global clinical research in Europe, America and China. 3. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved.