Olverembatinib is under clinical development by Ascentage Pharma Group International and currently in Phase III for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia). According to GlobalData, Phase III drugs for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia) have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Olverembatinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Olverembatinib overview

Olverembatinib (Nelic) is a third generation, ponatinib analog that acts by targeting spectrum of BCR-ABL mutants, including the T315I mutation. It is administered through oral route. Olverembatinib is indicated for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test.

Olverembatinib (third-generation Bcr-Abl inhibitor) is under development for the treatment of renal cell carcinoma (RCC), chronic myeloid leukemia (CLL), acute lymphocytic leukemia (ALL), Acute myeloid leukemia, gastric stromal tumor and coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) omicron variant mediated cytokine release. The drug candidate is a ponatinib analog. It is administered through oral route in the form of tablet and suspension. It acts by targeting Bcr-Abl tyrosine kinase.

Ascentage Pharma Group International overview

Ascentage Pharma Group International (Ascentage Pharma) is a clinical-stage biopharmaceutical company that primarily focuses on the development of novel therapies for cancers, chronic hepatitis B and age-related diseases. The company specializes in designing inhibitors of protein-protein interactions (PPIs) to restore apoptosis or programmed cell death. Its product portfolio includes clinical drug candidates, such as novel Bcl-2/Bcl-xL inhibitors, IAP and MDM2-p53 pathway candidates, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma’s core drug candidate, Olverembatinib, is used for the treatment of drug-resistant chronic myeloid leukemia (CML). The company’s products are used in the healthcare industry, specifically in the treatment of various diseases including cancers and hepatitis B. The company is currently conducting several Phase I/II clinical trials in the US, Australia, Europe, and China. It has offices in the US, Australia and China. Ascentage Pharma is headquartered in Suzhou, Jiangsu, China.

For a complete picture of Olverembatinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.