{"entity":{"id":"garsorasib","kind":"drug","name":"Garsorasib","aka":[],"tldr":"Garsorasib is InventisBio's KRAS G12C-blocking pill, approved in China in 2024 for previously treated lung cancer with that mutation.","summary":"Approved by the NMPA in August 2024 for KRAS G12C-mutant advanced NSCLC after prior systemic therapy, on a single-arm phase 2 trial that followed the phase 1 study published in the Journal of Thoracic Oncology in 2023. With fulzerasib it made China the second market with domestic KRAS G12C inhibitors; combination studies with EGFR antibodies and SHP2 inhibitors are under way.","status":"approved","asOf":"2026-09-10","links":[{"label":"InventisBio","url":"https://www.inventisbio.com/"},{"label":"D-1553 phase 1 (J Thorac Oncol 2023)","url":"https://doi.org/10.1016/j.jtho.2023.03.015"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":["kras-inhibitors","kinase-inhibitors"],"targets":["kras"],"drugs":[],"companies":["inventisbio"],"institutions":[],"pathways":["ras-mapk"],"terms":["kras-mutation-subtypes"],"trials":["nct06300177","nct04585035","nct05379946"],"people":[],"bottlenecks":[],"keyPapers":["paper-li-j-thorac-oncol"],"journals":[],"dependsOn":[],"notes":[],"code":"D-1553","modality":"Small-molecule covalent KRAS G12C inhibitor","mechanism":"Covalent KRAS G12C inhibitor binding the switch II pocket of the GDP-bound mutant protein.","approvals":[{"region":"China","year":2024,"indication":"KRAS G12C-mutant advanced NSCLC after at least one systemic therapy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/garsorasib/","neighbours":{"cancer":[{"id":"kras-g12c-nsclc","kind":"cancer","name":"KRAS G12C-mutant non-small-cell lung cancer","route":"/cancers/kras-g12c-nsclc/"},{"id":"kras-g12c-pdac","kind":"cancer","name":"KRAS G12C-mutant pancreatic ductal adenocarcinoma","route":"/cancers/kras-g12c-pdac/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kras-inhibitors","kind":"technology","name":"KRAS & RAS inhibitors","route":"/technologies/kras-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"shp2","kind":"target","name":"SHP2 (PTPN11)","route":"/targets/shp2/"}],"company":[{"id":"inventisbio","kind":"company","name":"InventisBio","route":"/companies/inventisbio/"}],"pathway":[{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"}],"term":[{"id":"kras-mutation-subtypes","kind":"term","name":"KRAS mutation subtypes (G12C, G12D, G12V)","route":"/terms/kras-mutation-subtypes/"}],"trial":[{"id":"nct07601048","kind":"trial","name":"A Trial of HRS-7058 in Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment","route":"/trials/nct07601048/"},{"id":"nct06300177","kind":"trial","name":"D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standar","route":"/trials/nct06300177/"},{"id":"nct05379946","kind":"trial","name":"Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors","route":"/trials/nct05379946/"},{"id":"nct04585035","kind":"trial","name":"Study to Evaluate D-1553 in Subjects With Solid Tumors","route":"/trials/nct04585035/"}],"paper":[{"id":"paper-li-j-thorac-oncol","kind":"paper","name":"D-1553 (Garsorasib), a Potent and Selective Inhibitor of KRAS G12C in Patients With NSCLC: Phase 1 Study Results","route":"/key-papers/paper-li-j-thorac-oncol/"}]}}