Ascletis
Ascletis Pharma Inc. is an innovative R&D driven biotech company listed on the Hong Kong Stock Exchange, focusing on three therapeutic areas with unmet medical needs: viral diseases, non-alcoholic steatohepatitis (NASH), and oncology. The company develops and commercializes innovative drugs, with a pipeline that includes drugs for hepatitis B, hepatitis C, COVID-19, HIV/AIDS, NASH, PBC, and cancer. It has three marketed products and 20 drug candidates in its pipeline, aiming to lead in global competition.
Industries
Nr. of Employees
large (251-1000)
Patents
Products
Oral ritonavir tablet (100 mg)
Oral pharmacokinetic booster tablet formulated to increase bioavailability of co-administered antivirals; subject to regulatory submissions in multiple countries and scaled manufacturing.
Oral HCV protease inhibitor (danoprevir)
Oral HCV protease inhibitor used in combination regimens for hepatitis C and studied for repurposing in infectious disease contexts.
Subcutaneously administered PD-L1 antibody for chronic hepatitis B
Subcutaneous PD-L1 antibody under clinical development for functional cure of chronic hepatitis B with demonstrated safety/tolerability in early-phase studies.
Oral PD-L1 small-molecule inhibitor prodrug (oral immune checkpoint inhibitor)
Oral small-molecule PD-L1 inhibitor prodrug developed for treatment of advanced solid tumors, with preclinical antitumor efficacy and early-phase clinical evaluation.
Oral RdRp inhibitor (broad-spectrum antiviral prodrug)
Oral double-prodrug RdRp inhibitor that converts to an active nucleoside analog with broad-spectrum antiviral activity, advanced into IND-enabled development for viral indications.
Oral 3CLpro inhibitor for COVID-19
Oral small-molecule 3CL protease inhibitor developed for SARS-CoV-2 with demonstrated in vitro potency and progression into clinical development.
Oral ritonavir tablet (100 mg)
Oral pharmacokinetic booster tablet formulated to increase bioavailability of co-administered antivirals; subject to regulatory submissions in multiple countries and scaled manufacturing.
Oral HCV protease inhibitor (danoprevir)
Oral HCV protease inhibitor used in combination regimens for hepatitis C and studied for repurposing in infectious disease contexts.
Subcutaneously administered PD-L1 antibody for chronic hepatitis B
Subcutaneous PD-L1 antibody under clinical development for functional cure of chronic hepatitis B with demonstrated safety/tolerability in early-phase studies.
Oral PD-L1 small-molecule inhibitor prodrug (oral immune checkpoint inhibitor)
Oral small-molecule PD-L1 inhibitor prodrug developed for treatment of advanced solid tumors, with preclinical antitumor efficacy and early-phase clinical evaluation.
Oral RdRp inhibitor (broad-spectrum antiviral prodrug)
Oral double-prodrug RdRp inhibitor that converts to an active nucleoside analog with broad-spectrum antiviral activity, advanced into IND-enabled development for viral indications.
Oral 3CLpro inhibitor for COVID-19
Oral small-molecule 3CL protease inhibitor developed for SARS-CoV-2 with demonstrated in vitro potency and progression into clinical development.
Services
End-to-end clinical trial services including multi-center Phase I–III study conduct, randomization, blinding, patient dosing and data collection.
Commercial manufacturing, capacity expansion, and distribution services for oral antiviral tablets including large-volume production planning and quality control.
Preclinical pharmacology, animal efficacy studies, in vitro antiviral testing and biomarker development to support INDs and clinical translation.
End-to-end clinical trial services including multi-center Phase I–III study conduct, randomization, blinding, patient dosing and data collection.
Commercial manufacturing, capacity expansion, and distribution services for oral antiviral tablets including large-volume production planning and quality control.
Preclinical pharmacology, animal efficacy studies, in vitro antiviral testing and biomarker development to support INDs and clinical translation.
Expertise Areas
- Clinical trial management
- Antiviral drug discovery and development
- NASH and metabolic disease drug development
- Oncology drug discovery (immune checkpoint and metabolic checkpoint inhibitors)
Key Technologies
- Prodrug design and active metabolite characterization
- Oral small-molecule protease inhibitors (3CLpro)
- RNA-dependent RNA polymerase inhibitors
- PD-L1 pathway inhibition (antibody and small-molecule approaches)
News & Updates
Ascletis Inc. has achieved a significant milestone with its triple therapy HCV drug in phase II trials among Chinese patients, showing promising efficacy and safety results.
The small-sample clinical study demonstrated that danoprevir combined with ritonavir is safe and well tolerated in all COVID-19 patients enrolled, with all patients discharged after treatment.
Ascletis announced that its Phase IIb clinical trial results of ASC22 (Envafolimab) in patients with chronic hepatitis B were presented at the International Liver Congress 2022, showing promising potential for a functional cure.
The China NMPA approved the IND application for ASC61, an oral PD-L1 small molecule inhibitor, to treat advanced solid tumors, with ongoing Phase I in the U.S.
Ascletis was included in the MSCI China Small Cap Index, effective after the market close on May 31, 2022, recognizing its business and growth prospects.
Ascletis completed its first sale of ritonavir tablets in Zhejiang Province through its distributor Zhejiang Int’l Medicine Co., Ltd.
Ascletis Inc. has achieved a significant milestone with its triple therapy HCV drug in phase II trials among Chinese patients, showing promising efficacy and safety results.
The small-sample clinical study demonstrated that danoprevir combined with ritonavir is safe and well tolerated in all COVID-19 patients enrolled, with all patients discharged after treatment.
Ascletis announced that its Phase IIb clinical trial results of ASC22 (Envafolimab) in patients with chronic hepatitis B were presented at the International Liver Congress 2022, showing promising potential for a functional cure.
The China NMPA approved the IND application for ASC61, an oral PD-L1 small molecule inhibitor, to treat advanced solid tumors, with ongoing Phase I in the U.S.
Ascletis was included in the MSCI China Small Cap Index, effective after the market close on May 31, 2022, recognizing its business and growth prospects.
Ascletis completed its first sale of ritonavir tablets in Zhejiang Province through its distributor Zhejiang Int’l Medicine Co., Ltd.