科学研究

歌礼专注于乙肝功能性治愈创新药物的研发。探索以皮下注射PD-L1抗体ASC22与其他靶点药物联合的治疗方案,有望为乙肝功能性治愈带来重大突破。



乙肝功能性治愈:ASC22(KN035)作用机制


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长时间处于活化状态的T细胞导致PD-1高表达。通过PD-1抗体或PD-L1抗体,阻断PD-1与PDL-1 连接,T细胞可以保持活化,发挥免疫功能,实现临床治愈。


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在慢性丙型肝炎领域,歌礼目前拥有两款全口服治疗方案,其中戈诺卫®/新力莱®方案已经获批上市。


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学术发表



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发表场所

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时间

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

2023年美国肝病研究协会(AASLD)年会(The Liver Meeting® 2023)海报11/2023
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 study第12届IAS艾滋病毒科学会议(The 12th International AIDS Society (IAS) Conference)海报7/2023
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 treatment欧洲肝脏研究协会(EASL)2023年国际肝脏大会(The International Liver Congress™ 2023)海报
6/2023

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

2023年第33届欧洲临床微生物与传染病学会年会(The 33rd ECCMID 2023)海报
4/2023
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 level2023年亚太肝脏研究协会(APASL)年会(APASL Annual Meeting 2023)口头报告2/2023

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 analogs

欧洲肝脏研究协会(EASL)2022年国际肝脏大会(The International Liver Congress™ 2022)口头报告6/2022
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 Trial2021年美国肝病研究协会(AASLD)年会(The Liver Meeting® 2021)口头报告11/2021
A Phase IIa trial of Subcutaneously Administered   PD-L1 Antibody ASC22 (Envafolimab) in Patients with Chronic Hepatitis B2021年美国肝病研究协会(AASLD)年会(The Liver Meeting® 2021)口头报告11/2021
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.论文04/2021

Significant in vitro and in vivo inhibition of HBsAg and HBV pgRNA with ASC42, a novel non-steroidal FXR agonist

欧洲肝病学会(EASL)年会   (International Liver Congress™ 2021)海报04/2021
First clinical study using   HCV protease inhibitor danoprevir to treat COVID-19 patients Medicine (2020) 99:48 论文11/2020
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.论文10/2019
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):213-220论文09/2019
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):221-225论文07/2019
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–e382海报04/2019
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):S86摘要02/2019
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.论文04/2018
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).论文01/2018
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 China2018年美国肝病研究协会(AASLD)年会(The Liver Meeting® 2018)海报11/2018
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):S190海报02/2017
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 论文10/2016
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. 论文01/2015