Ascletis Announces U.S. IND Filing of Oral RdRp Inhibitor Drug Candidate ASC10 for COVID-19

-- ASC10 is an oral small molecule drug candidate,which is in-house discovered and developed,and Ascletis retains full global rights for its development and commercialization

--This IND filing of ASC10 in the U.S. will accelerate Ascletis' global multi-center clinical studies on ASC10 and better position its oral drug pipeline of COVID-19

HANGZHOU,China and SHAOXING,China,July 6,2022 --Ascletis Pharma Inc. (HKEX: 1672,"Ascletis") today announces that the Investigational New Drug (IND) application of ASC10,an oral inhibitor drug candidate targeting RNA-dependent RNA polymerase (RdRp) for Coronavirus Disease 2019 (COVID-19),has been filed to the U.S. Food and Drug Administration (FDA) after the Pre-IND consultation.

Targeting RdRp of SARS-CoV-2 virus,ASC10 is an oral small molecule drug candidate for patients with COVID-19. ASC10 is an orally bioavailable,double prodrug of the antiviral nucleoside analog ASC10-A,which demonstrates potent inhibitory effect of RdRp of SARS-CoV-2 virus. ASC10-A demonstrated an excellent in vitro antiviral activity against multiple SARS-CoV-2 virus variants including Omicron in preclinical studies.

Ascletis is committed to developing and manufacturing safe,effective,affordable oral drugs for COVID-19 globally. As a leading biotech company in China,Ascletis has completed IND filing of ASC10,an oral RdRp inhibitor drug candidate for COVID-19 with the U.S. FDA. At the same time,the IND filing of ASC10 in China is proceeding on track.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK),covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record,Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases,non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution,Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date,Ascletis has three marketed products,i.e. ritonavir tablets,GANOVO® and ASCLEVIR®,and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure),ASC10 and ASC11 (oral small molecules for COVID-19 treatment),ASC40 (recurrent glioblastoma),ASC42 (PBC,primary biliary cholangitis),and ASC40 (acne).

For more information,please visit www.ascletis.com.