Olverembatinib
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.
Overview
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.
Inhibits BCR-ABL including the T315I gatekeeper mutation that defeats imatinib, dasatinib and nilotinib, and several other kinases; taken every other day. Connects to BCR::ABL1 (Philadelphia chromosome).
1.Olverembatinib slips into a pocket on BCR::ABL1 (Philadelphia chromosome).
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas · Lines of therapy.
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Approvals
| Region | Year | Indication |
|---|---|---|
| CN | 2021 | Chronic myeloid leukaemia (chronic or accelerated phase) with the T315I mutation after prior tyrosine kinase inhibitors |
Trials
topTrials recruiting now
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Landmark trials
Latest papers
topQuery for this drug: (TITLE:"Olverembatinib" OR ABSTRACT:"Olverembatinib" OR TITLE:"HQP1351" OR ABSTRACT:"HQP1351" OR TITLE:"GZD824" OR ABSTRACT:"GZD824") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Olverembatinib, not a curated reading list.
Similar pages
not linked directly; found by shared links- CompanyAscentage Pharma
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