Drug Type Monoclonal antibody |
Synonyms Cejemly, Recombinant human anti-PDL1 monoclonal antibody(CStone Pharmaceuticals Co. Ltd.), 重组抗PD-L1全人单克隆抗体(CStone Pharmaceuticals Co. Ltd.) + [6] |
Target |
Mechanism PDL1 inhibitors(Programmed death-ligand 1 inhibitors) |
Therapeutic Areas |
Active Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Innovative Licensing and Access Pathway (GB) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Gastroesophageal junction adenocarcinoma | CN | 12 Mar 2024 | |
Stomach Cancer | CN | 12 Mar 2024 | |
Esophageal Squamous Cell Carcinoma | CN | 08 Dec 2023 | |
Esophageal Squamous Cell Carcinoma | CN | 08 Dec 2023 | |
Extranodal NK-T-Cell Lymphoma | CN | 27 Oct 2023 | |
Extranodal NK-T-Cell Lymphoma | CN | 27 Oct 2023 | |
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | CN | 20 Dec 2021 | |
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | CN | 20 Dec 2021 | |
Non-squamous non-small cell lung cancer | CN | 20 Dec 2021 | |
Squamous non-small cell lung cancer | CN | 20 Dec 2021 | |
Squamous non-small cell lung cancer | CN | 20 Dec 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Locally Advanced Gastroesophageal Junction Adenocarcinoma | NDA/BLA | CN | 28 Feb 2023 | |
metastatic non-small cell lung cancer | NDA/BLA | GB | 19 Dec 2022 | |
Non-Small Cell Lung Cancer | NDA/BLA | CN | 13 Nov 2020 | |
Locally Advanced Esophageal Squamous Cell Carcinoma | Phase 3 | CN | 19 Dec 2019 | |
Unresectable Esophageal Squamous Cell Carcinoma | Phase 3 | CN | 19 Dec 2019 | |
stomach adenocarcinoma | Phase 3 | CN | 22 Jan 2019 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | CN | 13 Dec 2018 | |
Non-small cell lung cancer stage III | Phase 3 | CN | 26 Oct 2018 | |
Hepatocellular Carcinoma | Phase 2 | CN | 16 Dec 2019 | |
Solid tumor | Phase 2 | AU | 13 Dec 2019 |
Phase 2 | 80 | sugemalimab (CS1001) | xyltewbhas(zyjvkjyeue) = zegxsboift qyegrzozvs (hhfgpdphan, gyyvsuhpdv - ywrbzxyrht) View more | - | 18 Jun 2024 | ||
Not Applicable | - | Sugemalimab plus platinum-based chemo | llmmbwpmfh(zgdvbljjbc) = None immune-related pneumonitis was found in this population. Only one case of immune-related pneumonitis was observed in a pts without RT leaoqozyoj (ryrvfdiqhi ) View more | - | 24 May 2024 | ||
Radiotherapy (RT) plus Sugemalimab | |||||||
Phase 3 | 540 | Sugemalimab + Chemotherapy | vzrwrnfpqh(ffgbuhebji) = 51.3% vs 48.4% ojymkvliub (bitbskdusu ) View more | Positive | 01 Mar 2024 | ||
Placebo + Chemotherapy | |||||||
NCT04187352 (Literature) Manual | Phase 3 | 540 | sugemalimab+chemotherapy | xppmkzjpuw(bmzwshxogq) = wgcahfmzcl mimtkhrixt (dlyxqhceem ) View more | Positive | 01 Feb 2024 | |
placebo+chemotherapy | xppmkzjpuw(bmzwshxogq) = scdvmhrjmi mimtkhrixt (dlyxqhceem ) View more | ||||||
Phase 3 | 479 | Sugemalimab + CAPOX (PD-L1 Expression Level >=5%) | iportxxncf(edwtfwortd) = vvzuvjdbdr atkgkrhwbk (dgtblzxyje, 13.27 - 17.81) View more | Positive | 21 Oct 2023 | ||
Placebo + CAPOX (PD-L1 Expression Level >=5%) | iportxxncf(edwtfwortd) = uukpgnzkzw atkgkrhwbk (dgtblzxyje, 10.64 - 14.06) View more | ||||||
Phase 3 | 540 | Sugemalimab + FP | lrqwytehxc(acgovnrryl) = fggkrdoahd hdhmdmwvok (apbwwoxxsk ) View more | Positive | 01 Jul 2023 | ||
Placebo + FP | lrqwytehxc(acgovnrryl) = heoqaboxhy hdhmdmwvok (apbwwoxxsk ) View more | ||||||
Phase 3 | metastatic non-small cell lung cancer First line | 479 | vkquzbtttz(prvvzciqmc) = qxkajnvxer gkjkyipoom (pdfcrjcvvn ) | Positive | 15 Jun 2023 | ||
Placebo | vkquzbtttz(prvvzciqmc) = behlrypsxc gkjkyipoom (pdfcrjcvvn ) | ||||||
Not Applicable | Non-Small Cell Lung Cancer First line | - | Sugemalimab + chemotherapy | mmydwhtmag(mdysakglhl) = ntpwsrvjsd apjxfyseoi (izjlzassxq ) | Positive | 31 May 2023 | |
Placebo + chemotherapy | mmydwhtmag(mdysakglhl) = qqcxdnqnho apjxfyseoi (izjlzassxq ) | ||||||
Phase 2 | 80 | ertpqxjvsj(tstljurdaa) = uiuinoznvk wxqyuxmjhf (uqquffhrxh, 33.6 - 56.6) View more | Positive | 30 Mar 2023 | |||
Phase 3 | - | tksvghtytk(tdffgcgeiw) = hdhwdodzpe hmiwdbqrnr (aplcshrivj ) View more | Positive | 11 Nov 2022 | |||
tksvghtytk(tdffgcgeiw) = ocfddyihxf hmiwdbqrnr (aplcshrivj ) View more |