Ascletis Received IND Approval for its NASH Drug

HANGZHOU,China and SHAOXING,China,Aug. 28,2019 -- Ascletis Pharma Inc. (1672.HK),an innovative R&D driven,commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral,cancer and fatty liver diseases,announces today that together with Sagimet Biosciences (formerly 3-V Biosciences,Inc),it received,through its subsidiary,IND approval from National Medical Products Administration (NMPA) for its non-alcoholic steatohepatitis (NASH) drug candidate ASC40 (Sagimet Biosciences code:TVB-2640).

ASC40 (TVB-2640),an orally bioavailable,first-in-class inhibitor of fatty acid synthase (FASN),is currently in a global Phase 2 trial in NASH of which the first patient was dosed in late April,2019 in the USA.

In this randomized,placebo-controlled global Phase 2 trial,investigators are evaluating the impact of ASC40 (TVB-2640) in about 90 NASH patients in the United States and about 25-30 NASH patients in China. Study participants will have at least 8% liver fat at baseline,as measured by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF),and evidence of stage F1 to F3 fibrosis. The primary endpoint is the impact of ASC40 (TVB-2640) on liver fat reduction,compared to baseline,following 12 weeks of daily,continuous dosing. Investigators will also evaluate ASC40 (TVB-2640)'s impact on levels of plasma triglycerides,liver enzymes,inflammatory and fibrotic biomarkers.

"We are excited by IND approval of ASC40 (TVB-2640) from NMPA for the global multi-center trial," said Jinzi J. Wu,PhD,Founder,Chairman and CEO of Ascletis,"Sagimet and Ascletis teams are working hand-in-hand to accelerate the advancement of ASC40 (TVB-2640) on a global scale."

About Ascletis

Ascletis isan innovative R&D driven biotech with two commercial productsand listed on Hong Kong Stock Exchange (Ascletis,1672.HK). Ascletis'mission is to address unmet medical needs in three therapeutic areas: viral,cancer and fatty liver diseases. Led by a management team with deep expertise and a proven track record,Ascletis has developed a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is now commercializing two drugs,Ganovo®(Danoprevir),the first direct-acting anti-viral agent for hepatitis C developed domestically for China,and Pegasys®(Peginterferon alfa-2a),a well-established pegylated interferon for hepatitis B&C partnered with Roche. Ascletis'R&D pipeline consists of antibody-based immunotherapy,first/best-in-class small molecules and siRNA at various clinical development stages. For more information,please visitwww.ascletis.com.