Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a global regulatory Phase III study for its Category 1 drug olverembatinib. The study aims to evaluate the efficacy of olverembatinib in treating patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) who have previously failed systemic treatment.
Olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), was conditionally approved for marketing in China on November 25, 2021. It is indicated for the treatment of chronic phase and accelerated phase chronic myeloid leukemia (CML CP/AP) with T315I mutation that is resistant to other TKI treatments. The drug, which is co-commercialized by Innovent Biologics Inc. (HKEX: 01801) in China, received an additional indication in China for adult patients with CML in the chronic phase (CP) who are resistant and/or intolerant to first and/or second-generation TKIs in November of the previous year.- Flcube.com
