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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.
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).
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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| Region | Year | Indication |
|---|---|---|
| CN | 2021 | Chronic myeloid leukaemia (chronic or accelerated phase) with the T315I mutation after prior tyrosine kinase inhibitors |
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Query 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.
Shares Chronic myeloid leukaemia, accelerated and blast phase, Chronic myeloid leukaemia (CML), Acute lymphoblastic leukaemia, Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, accelerated and blast phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors and the tag pipeline.