Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, olverembatinib is a potentially best-in-class drug that will be co-commercialized in China market by Innovent and Ascentage Pharma, for the benefit of more patients and their families. As China’s first third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval fills an important treatment gap in T315I-mutant CML, and marks a major milestone signifying that Ascentage Pharma has successfully entered the commercial-stage.
This approval for olverembatinib is based on the results from two pivotal Phase II studies – the HQP1351CC201 study and the HQP1351CC202 study. These results showed that olverembatinib is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and depth of clinical response is expected to increase with prolonged treatment period.
CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for an effective treatment.