{"entity":{"id":"olverembatinib","kind":"drug","name":"Olverembatinib","aka":["GZD824"],"tldr":"Olverembatinib is Ascentage Pharma's third-generation BCR-ABL inhibitor, approved in China in 2021 for chronic myeloid leukaemia carrying the T315I mutation, and now in global phase 3 trials against the established drugs; it was the one China-only approval OnCo found missing from the headline list.","summary":"Olverembatinib (HQP1351) was developed by Ascentage Pharma in Suzhou and approved by China's NMPA in November 2021 for chronic-phase and accelerated-phase chronic myeloid leukaemia with the T315I mutation, with a later extension to patients resistant or intolerant to first and second-generation inhibitors. Its global programme, partnered with Takeda from 2024, includes the phase 3 POLARIS trials in previously treated chronic-phase CML and in Philadelphia-positive acute lymphoblastic leukaemia. It competes with ponatinib and asciminib, the two approved options for T315I disease outside China.","status":"approved","asOf":"2026-09-16","wikipedia":"https://en.wikipedia.org/wiki/Olverembatinib","links":[{"label":"ClinicalTrials.gov: trials of Olverembatinib","url":"https://clinicaltrials.gov/search?intr=HQP1351"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["cml","all-leukemia"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["bcr-abl"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct06423911","nct06640361","nct06051409"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2, curated)","editedOn":"2026-09-16"},"code":"HQP1351","modality":"Oral third-generation BCR-ABL tyrosine kinase inhibitor","mechanism":"Inhibits BCR-ABL including the T315I gatekeeper mutation that defeats imatinib, dasatinib and nilotinib, and several other kinases; taken every other day.","approvals":[{"region":"CN","year":2021,"indication":"Chronic myeloid leukaemia (chronic or accelerated phase) with the T315I mutation after prior tyrosine kinase inhibitors"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/olverembatinib/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"bcr-abl","kind":"target","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/targets/bcr-abl/"}],"trial":[{"id":"nct06051409","kind":"trial","name":"A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)","route":"/trials/nct06051409/"},{"id":"nct06640361","kind":"trial","name":"A Study of Olverembatinib in SDH-deficient GIST.","route":"/trials/nct06640361/"},{"id":"nct04501120","kind":"trial","name":"Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML","route":"/trials/nct04501120/"},{"id":"nct06423911","kind":"trial","name":"Study of Olverembatinib (HQP1351) in Patients With CML-CP","route":"/trials/nct06423911/"}]}}