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

--ASC42 U.S. Phase I topline results expected in July 2021

--Together with U.S. IND approval and Fast Track designation, ASC42 well positioned to initiate the Phase II trial by the end of 2021


Shanghai, China, May 27, 2021-- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), 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.