Our Focus

Ascletis focus on breakthrough therapies for HBV functional cure with subcutaneously injected PD-L1 antibody - ASC22. 



HBV Functional Cure: ASC22 mechanism

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Prolonged activation of T cells leads to high expression of PD-1. By blocking the connection between PD-1 and PDL-1 through PD-1 antibodies or PD-L1 antibodies, T-cells can remain activated and exert immune functions, ultimately leading to clinical cure.

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In the area of chronic hepatitis C, Ascletis has twoall-oral regimen, among which ASCLEVIR®/GANOVO®regimen has been approved for marketing for marketing in China by National Medical Products Administration (NMPA).


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Publications


Title

Venue

Type

Date

HBsAg Loss in Chronic Hepatitis B Patients After 24-Week Treatment with Subcutaneously Administered PD-L1 Antibody ASC22 (Envafolimab): Interim Results from a Phase IIb Extension Cohort

The Liver Meeting® 2023 of the American   Association for the Study of Liver Diseases (AASLD)Late-breaking Poster11/2023
Anti-PD-L1 antibody ASC22 in combination with chidamide potentiates HIV latency reversal and immune function from ART-suppressed individuals: a single center,single-arm,phase Ⅱ studyThe 12th International AIDS Society (IAS) Conference (IAS 2023)Poster7/2023
A phase 2 study of ASC42, a novel farnesoid X receptor (FXR) agonist, in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) in chronic hepatitis B patients with 12-week treatmentThe International Liver Congress™ 2023 of the European Association for the Study of the Liver (EASL)Poster6/2023

In vivo evaluation of ASC10 against SARS-CoV-2 virus in K18-hACE2 mouse SARS-CoV-2 model

The 33rd European Congress of Clinical Microbiology & Infectious Diseases(ECCMID) 2023Poster4/2023
Effects of Subcutaneous PD-L1 Antibody ASC22 (Envafolimab) Plus nucleos(t)ide analogs on HBsAg reduction in patients with chronic hepatitis B infection are correlated with pre-treatment HBsAg levelThe 2023 Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL)Oral2/2023
ALT flares were linked to HBsAg reduction, seroclearance and seroconversion: interim results from a Phase IIb study in chronic hepatitis B patients with 24-week treatment of subcutaneous PD-L1 antibody ASC22 (Envafolimab) plus nucleos(t)ide analogsThe International Liver Congress™ 2022 of the European Association for the Study of the Liver (EASL)Oral6/2022
HBsAg Loss in Chronic Hepatitis B Patients with   Subcutaneous PD-L1 Antibody ASC22 ( Envafolimab ) plus Nucleos (t)ide Analogs   Treatment : Interim Results from a Phase IIb Clinical TrialThe Liver Meeting® 2021 of the American Association for the Study of Liver Diseases (AASLD)Oral11/2021
A Phase IIa trial of Subcutaneously Administered PD-L1 Antibody ASC22   (Envafolimab) in Patients with Chronic Hepatitis BThe Liver Meeting® 2022 of the American Association for the Study of Liver Diseases (AASLD)Oral11/2021
Efficacy   and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C   infection without cirrhosis or with compensated cirrhosis (STORM-C-1):   interim analysis of a two-stage, open-label, multicentre, single arm, phase   2/3 trialThe Lancet Gastroenterology &   Hepatology, Volume 6, Issue 6.Paper04/2021
Significant in vitro and in vivo inhibition of   HBsAg and HBV pgRNA with ASC42, a novel non-steroidal FXR agonistThe   International Liver Congress™ 2021 of the European Association for the Study of the Liver (EASL)Poster
04/2021
First clinical study using HCV protease   inhibitor danoprevir to treat COVID-19 patients Medicine (2020) 99:48 Paper11/2020
利托那韦强化的达诺瑞韦联合达拉他韦治疗1b型慢性丙型肝炎的临床疗效分析中华临床感染病杂志,   2019(05):350-351-352-353-350-353,371.Paper10/2019
Efficacy and Safety of All-oral, 12-week   Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin in Treatment-naïve   Noncirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial   in ChinaJournal of Clinical and Translational   Hepatology 2019;7(3):213-220Paper09/2019
Efficacy and  safety of 12-week   interferon-based danoprevir regimen in patients with  genotype 1 chronic   hepatitis CJournal of Clinical and Translational Hepatology 2019;7(3):221-225Paper07/2019
All-oral, 12-week  ravidasvir plus   ritonavir-boosted danoprevir and ribavirin delivers 100% svr12 in   treatment-naive noncirrhotic hcv genotype 1 patients with    resistance-associated substitutions of a phase 2/3 clinical trial in   ChinaJournal of Hepatology 2019 vol. 70 | e141–e382Poster04/2019
12 week Ravidasvir plus ritonavir-boosted   Danoprevir and ribavirin achieves 99% SVR12 in treatment-naı ¨ve non- cirrhotic HCV GT1 patients: Subanalysis of phase 2/3   clinical trial in China Hepatol Int (2019) 13 (Suppl 1):S86Abstract02/2019
达诺瑞韦及其联合PR方案治疗慢性丙型肝炎研究进展中华临床感染病杂志,2018,11(02):84-89.Paper04/2018
Twelve-week  Ravidasvir plus   ritonavir-boosted Danoprevir and ribavirin for non- cirrhotic  HCV   genotype 1 patients: A phase 2 studyJournal of Gastroenterology & Hepatology, 2018, 33(8).Paper01/2018
The Effcacy and  Safety of All-Oral,   12-Week Ravidasvir Plus Ritonavir-Boosted Danoprevir and  Ribavirin in   Treatment-Naïve Non-Cirrhotic HCV Genotype 1 Patients : Results  from a   Phase 2/3 Clinical Trial in ChinaThe Liver Meeting® 2018 of the American Association for the Study of Liver Diseases (AASLD)Poster11/2018
MAKALU:  Twelve-week of treatment with   Ritonavir-boosted Danoprevir Pluzs Peginterferon  and Ribavirin produces   96% SVR12 in HCV Genotype 1-Infected Non-Cirrhotic  Chinese PatientsHepatol Int (2017) 11 (Suppl 1):S190Poster02/2017
Ritonavir-boosted  danoprevir plus   peginterferon alfa-2a and ribavirin in Asian chronic  hepatitis C   patients with or without cirrhosisJournal of Gastroenterology and Hepatology 31   (2016) 1757–1765 Paper10/2016
DAUPHINE: a randomized phase II study of   danoprevir/ritonavir plus peginterferon alpha-2a/ribavirin in HCV genotypes 1   or 4Liver International,2015,35(1):108-119. Paper01/2015