{"entity":{"id":"orelabrutinib","kind":"drug","name":"Orelabrutinib","aka":[],"tldr":"Orelabrutinib is InnoCare's BTK-blocking pill for chronic lymphocytic leukaemia and mantle cell lymphoma, approved in China in 2020.","summary":"Approved by the NMPA in December 2020 for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma and for relapsed or refractory mantle cell lymphoma, with relapsed or refractory marginal zone lymphoma added in 2023, the first approval for any BTK inhibitor in that disease. It competes with zanubrutinib and ibrutinib in China's NRDL and is being tested in primary central nervous system lymphoma and, outside oncology, in multiple sclerosis.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Orelabrutinib","links":[{"label":"InnoCare Pharma","url":"https://www.innocarepharma.com/en"},{"label":"NMPA (National Medical Products Administration)","url":"https://www.nmpa.gov.cn"}],"tags":["china"],"related":[],"cancers":["cll","mantle-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["btk"],"drugs":[],"companies":["innocare"],"institutions":[],"pathways":["bcr-signalling"],"terms":[],"trials":["nct06363994","nct06082102","nct04014205"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Yinuokai","code":"ICP-022","modality":"Small-molecule covalent BTK inhibitor (second generation)","mechanism":"Irreversible, highly selective covalent inhibitor of BTK with minimal off-target kinase activity, designed for once-daily dosing and central nervous system penetration.","approvals":[{"region":"China","year":2020,"indication":"Relapsed or refractory CLL/SLL; relapsed or refractory mantle cell lymphoma"},{"region":"China","year":2023,"indication":"Relapsed or refractory marginal zone lymphoma"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/orelabrutinib/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"malt-lymphoma","kind":"cancer","name":"Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)","route":"/cancers/malt-lymphoma/"},{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"btk","kind":"target","name":"BTK (Bruton tyrosine kinase)","route":"/targets/btk/"}],"company":[{"id":"innocare","kind":"company","name":"InnoCare Pharma","route":"/companies/innocare/"}],"pathway":[{"id":"bcr-signalling","kind":"pathway","name":"B-cell receptor / BTK signalling (to NF-κB)","route":"/pathways/bcr-signalling/"}],"trial":[{"id":"nct06363994","kind":"trial","name":"A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL","route":"/trials/nct06363994/"},{"id":"nct04014205","kind":"trial","name":"A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies","route":"/trials/nct04014205/"},{"id":"nct06082102","kind":"trial","name":"Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma","route":"/trials/nct06082102/"}]}}