{"entity":{"id":"sintilimab","kind":"drug","name":"Sintilimab","aka":[],"tldr":"Sintilimab is Innovent's PD-1 antibody, approved in China since 2018 for Hodgkin lymphoma and then, on the ORIENT trials, for first-line lung, liver, oesophageal and stomach cancer. In 2022 the FDA rejected its lung cancer application because a China-only trial against chemotherapy did not fit US practice, defining the agency's stance on single-country data.","summary":"First approved by the NMPA in December 2018 for relapsed or refractory classical Hodgkin lymphoma, then added by the ORIENT programme: first-line non-squamous NSCLC with pemetrexed-platinum (ORIENT-11), squamous NSCLC (ORIENT-12), first-line hepatocellular carcinoma with the bevacizumab biosimilar IBI305 (ORIENT-32), first-line oesophageal squamous cell carcinoma (ORIENT-15) and first-line gastric or gastro-oesophageal junction adenocarcinoma (ORIENT-16). Co-commercialised in China with Eli Lilly. In March 2022 the FDA issued a complete response letter for the ORIENT-11 indication after an advisory committee voted 14 to 1 that a single-country trial with a chemotherapy comparator did not fit US practice, the case that defined the agency's stance on China-only data. Listed on the National Reimbursement Drug List since 2019 after a steep negotiated price cut.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Sintilimab","links":[{"label":"Innovent: Tyvyt","url":"https://www.innoventbio.com/"},{"label":"ORIENT-11 (J Thorac Oncol 2020)","url":"https://doi.org/10.1016/j.jtho.2020.07.014"},{"label":"ORIENT-32 (Lancet Oncol 2021)","url":"https://doi.org/10.1016/S1470-2045(21)00252-7"},{"label":"ORIENT-16 (JAMA 2023)","url":"https://doi.org/10.1001/jama.2023.19918"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["nsclc","hcc","esophageal","gastric","hodgkin-lymphoma"],"sections":[],"technologies":["checkpoint-inhibitor","monoclonal-antibody"],"targets":["pd1"],"drugs":[],"companies":["innovent","eli-lilly"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":[],"trials":["orient-11","orient-32","orient-16","nct06584032","nct05116462","nct06497985","nct07521852","nct05632939","nct06558227","nct06530251","nct05890742","nct06220318"],"people":["yu-michael"],"bottlenecks":[],"keyPapers":["paper-xu-jama","paper-ren-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"brand":"Tyvyt","code":"IBI308","modality":"Monoclonal antibody (anti-PD-1, IgG4)","mechanism":"Fully human IgG4 antibody that blocks PD-1 binding to PD-L1 and PD-L2, restoring T-cell activity against the tumour.","approvals":[{"region":"China","year":2018,"indication":"Relapsed or refractory classical Hodgkin lymphoma after two or more lines"},{"region":"China","year":2021,"indication":"First-line non-squamous NSCLC with pemetrexed and platinum (ORIENT-11); first-line squamous NSCLC with gemcitabine and platinum (ORIENT-12); first-line unresectable hepatocellular carcinoma with IBI305 (ORIENT-32)"},{"region":"China","year":2022,"indication":"First-line oesophageal squamous cell carcinoma with chemotherapy (ORIENT-15)"},{"region":"China","year":2023,"indication":"First-line gastric or gastro-oesophageal junction adenocarcinoma with chemotherapy (ORIENT-16)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2022-03","type":"crl","region":"US","note":"Complete response letter for ORIENT-11 (first-line non-squamous NSCLC); ODAC voted 14 to 1 that additional data were needed for US applicability","source":"https://web.archive.org/web/20250302091714/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022"}]},"route":"/drugs/sintilimab/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"}],"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":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"pdcd1lg2","kind":"target","name":"PDCD1LG2","route":"/targets/pdcd1lg2/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. 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