{"entity":{"id":"sugemalimab","kind":"drug","name":"Sugemalimab","aka":[],"tldr":"Sugemalimab is CStone's PD-L1 antibody, approved in China for first-line lung cancer with chemotherapy and after chemoradiotherapy in stage III disease, and the first China-developed PD-L1 antibody to win European approval.","summary":"GEMSTONE-302 (479 patients, squamous and non-squamous metastatic NSCLC) gave a progression-free survival hazard ratio of 0.50 versus placebo plus platinum chemotherapy, the basis of the NMPA approval in December 2021. GEMSTONE-301 added unresectable stage III NSCLC after concurrent or sequential chemoradiotherapy in 2022, and relapsed or refractory extranodal NK/T-cell lymphoma followed. The European Commission approved sugemalimab with platinum chemotherapy for first-line metastatic NSCLC without EGFR, ALK, ROS1 or RET alterations in July 2024, making it the first anti-PD-L1 antibody from a Chinese company approved in the EU.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Sugemalimab","links":[{"label":"CStone Pharmaceuticals","url":"https://www.cstonepharma.com/en/"},{"label":"GEMSTONE-302 (Lancet Oncol 2022)","url":"https://doi.org/10.1016/S1470-2045(21)00650-1"},{"label":"EMA: Cejemly","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/cejemly"}],"tags":["china"],"related":[],"cancers":["nsclc","peripheral-t-cell-lymphoma","lung-cancer","stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":["pdl1"],"drugs":[],"companies":["cstone"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":[],"trials":["gemstone-302","nct06617416","gemstone-301"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Cejemly","code":"CS1001","modality":"Monoclonal antibody (anti-PD-L1, fully human IgG4)","mechanism":"Fully human anti-PD-L1 IgG4 antibody generated in the OmniRat platform; blocks PD-L1 binding to PD-1 and B7-1.","approvals":[{"region":"China","year":2021,"indication":"First-line metastatic squamous and non-squamous NSCLC with platinum chemotherapy (GEMSTONE-302)"},{"region":"China","year":2022,"indication":"Unresectable stage III NSCLC without progression after chemoradiotherapy (GEMSTONE-301)"},{"region":"EU","year":2024,"indication":"First-line metastatic NSCLC with platinum chemotherapy, no sensitising EGFR, ALK, ROS1 or RET alterations"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/sugemalimab/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"},{"id":"stage-iii-unresectable-nsclc","kind":"cancer","name":"Unresectable stage III non-small-cell lung cancer","route":"/cancers/stage-iii-unresectable-nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd80","kind":"target","name":"CD80 (B7-1)","route":"/targets/cd80/"},{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"company":[{"id":"cstone","kind":"company","name":"CStone Pharmaceuticals","route":"/companies/cstone/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"}],"trial":[{"id":"nct06617416","kind":"trial","name":"A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC","route":"/trials/nct06617416/"},{"id":"gemstone-301","kind":"trial","name":"GEMSTONE-301","route":"/trials/gemstone-301/"},{"id":"gemstone-302","kind":"trial","name":"GEMSTONE-302","route":"/trials/gemstone-302/"},{"id":"nct05623267","kind":"trial","name":"Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT","route":"/trials/nct05623267/"}]}}