# Olverembatinib

Source: https://onco.cc/drugs/olverembatinib/  
OnCo record `olverembatinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-16
- Also known as: GZD824
- Tags: pipeline; ctgov-ingest
- 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: CN 2021: Chronic myeloid leukaemia (chronic or accelerated phase) with the T315I mutation after prior tyrosine kinase inhibitors

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Olverembatinib
- ClinicalTrials.gov: trials of Olverembatinib: https://clinicaltrials.gov/search?intr=HQP1351

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Chronic myeloid leukaemia (CML)](https://onco.cc/cancers/cml/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BCR::ABL1 (Philadelphia chromosome)](https://onco.cc/targets/bcr-abl/)
- trials: [A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)](https://onco.cc/trials/nct06051409/), [A Study of Olverembatinib in SDH-deficient GIST.](https://onco.cc/trials/nct06640361/), [Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML](https://onco.cc/trials/nct04501120/), [Study of Olverembatinib (HQP1351) in Patients With CML-CP](https://onco.cc/trials/nct06423911/)

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