Olverembatinib tablets 奥雷巴替尼

Olebatinib is the first third-generation BCR-ABL inhibitor developed by a Chinese company and the first innovative drug approved by Ascentage Pharma in more than a decade since its founding. [1] This drug is an innovative drug independently developed by my country with independent intellectual property rights, used to treat any tyrosine kinase inhibitor resistance.
This product is the first drug approved in China for the indication of chronic myeloid leukemia with T315I mutation. [3]
On January 18, Narica was successfully included in the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalog (2022), and the scope of medical insurance payment is: “Limited to adult patients with chronic myeloid leukemia (CML) chronic phase (CP) or accelerated phase (AP) with T315I mutation. [4]
On November 17, 2023, Narica was approved by the National Medical Products Administration for the treatment of adult patients with chronic myeloid leukemia chronic phase (-CP) who are resistant and/or intolerant to first- and second-generation TKIs. [6]
Treatment population
This drug is an innovative drug independently developed by my country with independent intellectual property rights. It is used to treat adult patients with chronic or accelerated phase chronic myeloid leukemia with any tyrosine kinase inhibitor resistance and diagnosed with T315I mutation using a fully validated detection method. [1]
Olebatinib is used to treat adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs). [5]
Therapeutic methods
Olebatinib is a small molecule protein tyrosine kinase inhibitor that can effectively inhibit the activity of wild-type and multiple mutant Bcr-Abl tyrosine kinases, inhibit the phosphorylation of Bcr-Abl tyrosine kinase and downstream proteins STAT5 and Crkl, block downstream pathway activation, and induce cell cycle arrest and apoptosis in Bcr-Abl-positive and Bcr-Abl T315I mutant cell lines. [1]