Gannex Received China IND Approval of Its FXR Agonist ASC42 for NASH Indication

Gannex, a wholly owned company of Ascletis Pharma Inc., fully dedicated to the R&D and commercialization of new drugs in the field of non-alcoholic steatohepatitis (NASH), today announces that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its drug candidate ASC42 to conduct clinical trials for NASH indication.

ASC42 is an in-house developed, novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. ASC42 is an oral tablet formulation developed with in-house proprietary technology and is stable at room temperature. ASC42 is expected to be used alone and in combination with thyroid hormone receptor beta (THR-β) agonist ASC41 or fatty acid synthase (FASN) inhibitor ASC40.

In October 2020, Gannex received IND approval from the U.S. Food and Drug Administration (FDA) for ASC42 NASH indication. In December 2020, Gannex received Fast Track designation from the U.S. FDA. The U.S. Phase I topline results of ASC42 will be expected in July 2021.

"We are excited that both China NMPA and U.S. FDA have granted INDs for ASC42 which is a FXR agonist with best-in-class potential. We are looking forward to topline data from ASC42 U.S. Phase I trial and initiation of the Phase II trial in NASH patients by the end of 2021." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong, S.A.R., China Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer lipid metabolism and oral checkpoint inhibitors, viral hepatitis 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 seventeen R&D pipeline drug candidates or combination therapies (eleven of them developed in-house). 1. NASH: Gannex, a wholly-owned company of Ascletis, is fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THR-beta and FXR, and three combination therapies. 2. Cancer lipid metabolism and oral checkpoint inhibitors: focus on a pipeline of oral inhibitors targeting FASN which plays a key role in cancer lipid metabolism and a pipeline of oral PD-L1 small molecule inhibitors as the next generation checkpoint inhibitors. 3. Viral hepatitis: (i) Hepatitis B: focus on breakthrough therapies for HBV clinical cure with subcutaneously injected PD-L1 antibody - ASC22 and Pegasys® as cornerstone drugs. (ii) Hepatitis C: successfully launched all oral regimen of ASCLEVIR® and GANOVO® combination (RDV/DNV regimen); and ASC18 fixed dose combination (FDC) is an upgraded version of RDV/DNV regimen with bridging study finished. 4. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved.