# OnCo record sintilimab (drug). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/drugs/sintilimab/>
  a schema:Drug ;
  onco:kind "drug" ;
  schema:identifier "sintilimab" ;
  schema:name "Sintilimab"@en ;
  schema:description "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."@en ;
  schema:url <https://onco.cc/drugs/sintilimab/> ;
  schema:dateModified "2026-09-10"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Sintilimab> ;
  schema:citation <https://www.innoventbio.com/>, <https://doi.org/10.1016/j.jtho.2020.07.014>, <https://doi.org/10.1016/S1470-2045(21)00252-7>, <https://doi.org/10.1001/jama.2023.19918>, <https://www.nmpa.gov.cn> ;
  onco:status "approved" ;
  onco:tag "china" ;
  onco:modality "Monoclonal antibody (anti-PD-1, IgG4)" ;
  schema:alternateName "Tyvyt" ;
  onco:approval "China 2018: Relapsed or refractory classical Hodgkin lymphoma after two or more lines", "China 2021: 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)", "China 2022: First-line oesophageal squamous cell carcinoma with chemotherapy (ORIENT-15)", "China 2023: First-line gastric or gastro-oesophageal junction adenocarcinoma with chemotherapy (ORIENT-16)" ;
  onco:cancers <https://onco.cc/cancers/nsclc/>, <https://onco.cc/cancers/hcc/>, <https://onco.cc/cancers/esophageal/>, <https://onco.cc/cancers/gastric/>, <https://onco.cc/cancers/hodgkin-lymphoma/> ;
  onco:technologies <https://onco.cc/technologies/checkpoint-inhibitor/>, <https://onco.cc/technologies/monoclonal-antibody/> ;
  onco:targets <https://onco.cc/targets/pd1/> ;
  onco:companies <https://onco.cc/companies/innovent/>, <https://onco.cc/companies/eli-lilly/> ;
  onco:pathways <https://onco.cc/pathways/pd1-checkpoint/> ;
  onco:trials <https://onco.cc/trials/orient-11/>, <https://onco.cc/trials/orient-32/>, <https://onco.cc/trials/orient-16/>, <https://onco.cc/trials/nct06584032/>, <https://onco.cc/trials/nct05116462/>, <https://onco.cc/trials/nct06497985/>, <https://onco.cc/trials/nct07521852/>, <https://onco.cc/trials/nct05632939/>, <https://onco.cc/trials/nct06558227/>, <https://onco.cc/trials/nct06530251/>, <https://onco.cc/trials/nct05890742/>, <https://onco.cc/trials/nct06220318/> ;
  onco:people <https://onco.cc/people/yu-michael/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-xu-jama/>, <https://onco.cc/key-papers/paper-ren-lancet-oncol/> .