{"entity":{"id":"iruplinalkib","kind":"drug","name":"Iruplinalkib","aka":["Qixinke"],"tldr":"Iruplinalkib is Qilu Pharmaceutical's second-generation ALK inhibitor, approved in China in 2023 for ALK-positive non-small-cell lung cancer after crizotinib and in 2024 as first-line treatment.","summary":"Iruplinalkib (WX-0593) was developed by Qilu Pharmaceutical in Jinan. The NMPA approved it in June 2023 for locally advanced or metastatic ALK-positive non-small-cell lung cancer that had progressed on or was intolerant to crizotinib, and in 2024 extended the approval to first-line use after the INSPIRE phase 3 trial showed longer progression-free survival than crizotinib.","status":"approved","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov: trials of iruplinalkib","url":"https://clinicaltrials.gov/search?intr=WX-0593"}],"tags":["china","nmpa-approved"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["alk","ros1"],"drugs":[],"companies":["qilu-pharmaceutical"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo China deep dive","editedOn":"2026-09-16"},"code":"WX-0593","modality":"Oral ALK and ROS1 tyrosine kinase inhibitor","mechanism":"Blocks the ALK fusion kinase that drives about five percent of non-small-cell lung cancers, including resistance mutations that stop first-generation inhibitors.","approvals":[{"region":"CN","year":2023,"indication":"ALK-positive non-small-cell lung cancer after crizotinib; first line from 2024"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/iruplinalkib/","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":"alk","kind":"target","name":"ALK","route":"/targets/alk/"},{"id":"ros1","kind":"target","name":"ROS1","route":"/targets/ros1/"}],"company":[{"id":"qilu-pharmaceutical","kind":"company","name":"Qilu Pharmaceutical","route":"/companies/qilu-pharmaceutical/"}]}}