Ascletis' THR- beta Agonist ASC41 Receives Approval for Clinical Trials of NASH Indication

HANGZHOU,Chinaand SHAOXING,China,May 13,2020 -- Ascletis Pharma Inc. (HKEX code: 1672) announces today that it received IND approval from China's National Medical Products Administration (NMPA) for its in-house developed Category 1 Drug ASC41 to conduct clinical trials for Non-alcoholic Steatohepatitis (NASH) indication.

Ascletis has two additional drug candidates in its NASH pipeline: ASC40 in phase 2 and a pre-IND candidate. ASC41 is expected to be used alone or in combination with ASC40 or the pre-IND candidate. ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist,while ASC40 is an oral fatty acid synthase (FASN) inhibitor.

"We are pleased by the IND approval of ASC41 from NMPA,the 1st in-house developed drug candidate for NASH," said Dr. Jinzi J. Wu,Founder,Chairman and CEO of Ascletis. "With three drug candidates against three different targets in our NASH pipeline,Ascletis is accelerating the development of innovative drugs to benefit NASH patients globally."

About NASH

Non-alcoholic Steatohepatitis (NASH),also known as metabolic steatohepatitis,is mainly manifested in unexplained intrahepatic fat accumulation,which can lead to chronic liver inflammation and liver cell injury,and can lead to liver fibrosis,liver cirrhosis,and eventually lead to liver cancer or liver failure.

According to the Journal of Hepatology,there were 32.81 million people in China with NASH in 2016,and the number is expected to reach 48.26 million by 2030. Presently,there are no effective drugs worldwide for NASH.

About Ascletis

Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis,1672.HK). Ascletis is committed to developing and commercializing antiviral,steatohepatitis,and tumor-related innovative drugs 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' pipeline is focused primarily on three therapeutic areas: 1. HCV: one commercial stage product,one near commercial stage drug and two R&D stage drug candidates. Ganovo® (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C,developed by a domestic firm in China. 2. HBV: one commercial stage product and three R&D stage drug candidates. Pegasys® (Peginterferon alfa-2a) is a leading marketed pegylated interferon for hepatitis B&C partnered with Roche. 3. NASH (Non-Alcoholic SteatoHepatitis): three R&D stage drug candidates against three different targets for combination treatments. For more information,please visitwww.ascletis.com.