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Myeloid Leukemia: New Breakthrough Treatment

Ascentage Pharma, a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, and Innovent Biologics, Inc. (“Innovent”), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, jointly announce that the novel drug candidate olverembatinib of Guangzhou HealthQuest Pharma Co., Ltd., Inc., a wholly-owned subsidiary of Ascentage Pharma, has been approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test (an indication that has not been approved in the US).

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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.

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About the author

Linda Hohnholz, eTN editor

Linda Hohnholz has been writing and editing articles since the start of her working career. She has applied this innate passion to such places as Hawaii Pacific University, Chaminade University, the Hawaii Children's Discovery Center, and now TravelNewsGroup.

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