{"entity":{"id":"icotinib","kind":"drug","name":"Icotinib","aka":[],"tldr":"Icotinib, approved in 2011, was the first cancer drug invented and developed in China, and it showed that a domestic lung cancer pill could match a Western one head to head.","summary":"Betta Pharmaceuticals' icotinib was approved by the then SFDA in June 2011 for advanced NSCLC after chemotherapy, on the ICOGEN trial that showed non-inferiority to gefitinib (Lancet Oncology 2013). First-line EGFR-mutant approval followed in 2014, and the EVIDENCE trial (Lancet Respiratory Medicine 2021) supported adjuvant use after resection of stage II to IIIA EGFR-mutant disease. It was the first drug in the 2016 pilot of national price negotiation, taking a large cut to enter reimbursement, the template for the later NRDL rounds.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Icotinib","links":[{"label":"Betta Pharmaceuticals","url":"https://www.bettapharma.com/"},{"label":"ICOGEN (Lancet Oncol 2013)","url":"https://doi.org/10.1016/S1470-2045(13)70355-3"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["egfr"],"drugs":[],"companies":["betta"],"institutions":[],"pathways":["ras-mapk"],"terms":[],"trials":["nct06041776"],"people":[],"bottlenecks":[],"keyPapers":["paper-shi-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"brand":"Conmana","code":"BPI-2009H","modality":"Small-molecule first-generation EGFR TKI","mechanism":"Reversible ATP-competitive inhibitor of EGFR tyrosine kinase, structurally related to erlotinib.","approvals":[{"region":"China","year":2011,"indication":"Advanced NSCLC after failure of at least one chemotherapy regimen (ICOGEN)"},{"region":"China","year":2014,"indication":"First-line EGFR-mutant NSCLC"},{"region":"China","year":2021,"indication":"Adjuvant treatment of resected stage II to IIIA EGFR-mutant NSCLC (EVIDENCE)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/icotinib/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"betta","kind":"company","name":"Betta Pharmaceuticals","route":"/companies/betta/"}],"pathway":[{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"}],"trial":[{"id":"nct06041776","kind":"trial","name":"Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations","route":"/trials/nct06041776/"},{"id":"nct06955325","kind":"trial","name":"Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations","route":"/trials/nct06955325/"}],"paper":[{"id":"paper-shi-lancet-oncol","kind":"paper","name":"Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial","route":"/key-papers/paper-shi-lancet-oncol/"}]}}