Ascentage Pharma announced that olverembatinib (R&D Code: HQP1351) has been included in the latest guidelines from the National Comprehensive Cancer Network (NCCN) for the management of Chronic Myeloid Leukemia (CML), marking a major development in global recognition for its best-in-class drug candidate, which has been approved in China for the management of tyrosine kinase inhibitor (TKI)-resistant patients with chronic- and accelerated-phase CML (CML-CP and CML-AP). Clinical trials also suggest that olverembatinib has demonstrated effects regarding safety of the compound, with its common adverse events such as thrombocytopenia, hypertriglyceridemia, and chiefly asymptomatic elevation of enzymes that include creatine phosphokinase and liver transaminase, being typically grade 1-2 and manageable. Olverembatinib is a novel, small-molecule, orally administered, third-generation BCR-ABL1 TKI initially approved in China in November 2021 for the treatment of adult patients with TKI-resistant CML-CP or CML-AP harbouring the T315I mutation; and then in November 2023 for the treatment of adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs.

Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.