Ascentage Pharma announced the launch of olverembatinib in newly approved indication and the dispatch of first batch for the new indication. On November 17, 2023, the China National Medical Products Administration (NMPA) approved olverembatinib (HQP1351) for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs). This approval, marking yet another major milestone for olverembatinib following its first regulatory approval in 2021 and the subsequent inclusion into the China 2022 National Reimbursement Drug List (NRDL), which will benefit a broader population of patients with CML in China.

This approval for olverembatinib is based on the results from an open-label, national multicenter, randomized-controlled, registrational pivotal Phase II study (HQP1351CC203) that evaluated the efficacy and safety of olverembatinib in patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs. Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT). Results from the study show that compared to patients who were treated with the BAT in the control group, those received olverembatinib achieved statistically significant improvement in the primary endpoint of event-free survival (EFS), meeting the primary endpoint of the study.

In March 2021, the Center of Drug Evaluation (CDE) of the NMPA granted olverembatinib a Breakthrough Therapy Designation (BTD) to olverembatinib; and in July 2022, the New Drug Application (NDA) for olverembatinib in this indication was accepted and granted a Priority Review Designation by the CDE.