Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) who have the T315I mutation and are resistant to TKIs, as well as adult patients with CML-CP that is resistant to and/or intolerant of first and second-generation TKIs.
Olverembatinib, the first and only third-generation BCR-ABL TKI available in China, was conditionally approved for marketing on November 25, 2021, for use in CML CP/AP with T315I mutation that is resistant to other TKI treatments. This Category 1 drug is co-commercialized by Innovent Biologics Inc. (HKG: 1801) in China. The drug expanded its indications in China in November of the previous year, gaining approval for use in adult patients with CML-CP who are resistant and/or intolerant to first and/or second-generation TKIs.- Flcube.com
