Drug Profile

Olverembatinib - Ascentage Pharma

Alternative Names: APG 1351; BCR-ABL TKI; D 824; GZD 824; HQP 1351; IBI-348; Orebatinib

Latest Information Update: 29 Oct 2025

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At a glance

Originator Guangzhou Institutes of Biomedicine and Health
Developer Ascentage Pharma; Innovent Biologics; Takeda; University of Texas M. D. Anderson Cancer Center
Class Antineoplastics; Benzamides; Fluorinated hydrocarbons; Piperazines; Pyrazoles; Pyridines; Small molecules
Mechanism of Action Bcr-Abl tyrosine kinase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Gastrointestinal stromal tumours; Chronic myeloid leukaemia; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
New Molecular Entity Yes

Marketed Chronic myeloid leukaemia
Phase III Gastrointestinal stromal tumours; Precursor cell lymphoblastic leukaemia-lymphoma
Phase I/II Solid tumours
Preclinical COVID 2019 infections; Renal cell carcinoma
No development reported Acute myeloid leukaemia

13 Oct 2025 Phase-II clinical trials in Chronic myeloid leukaemia (Monotherapy) in USA (PO) (NCT06817720)
20 Aug 2025 Ascentage Pharma plan to seek clearance from the FDA to initiate a registrational phase III clinical trial in Precursor cell lymphoblastic leukaemia lymphoma
20 Aug 2025 Ascentage Pharma plans to initiate a registrational phase III clinical trial in Precursor cell lymphoblastic leukaemia lymphoma

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