Health Canada approves Ascentage Pharmas phase Ib study application for olverembatinib to treat patients with refractory CML or Ph ALL

Ascentage Pharma, a global biopharmaceutical company, announced that the phase Ib study of Ascentage Pharma's novel drug candidate, olverembatinib (HQP1351), for the treatment of patients with refractory chronic myeloid leukaemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) has been approved by Health Canada, making it Ascentage Pharma's first clinical study in the country. This open-label, multicenter, randomized, global phase Ib study is designed to evaluate the safety, efficacy, pharmacokinetics (PK) and determine the recommended phase II dose (RP2D) of olverembatinib in patients with CML in chronic-phase (CP), accelerated-phase (AP), or blast-phase (BP) or with Ph+ ALL, who are resistant or intolerant to at least two tyrosine kinase inhibitors (TKIs). CML is a hematologic malignancy of the white blood cells. The commercialization of BCR-ABL TKIs has revamped the treatment 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. Currently, there is an urgent unmet medical need for a new generation of TKIs that can safely and effectively target the BCR-ABL mutation. Olverembatinib is a novel, orally active, third-generation BCR-ABL inhibitor developed by Ascentage Pharma for the treatment of patients with CML resistant to first- and second-generation TKIs. It can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. As the first approved third-generation BCR-ABL inhibitor in China and the second globally, olverembatinib is a novel therapeutic with global "best-in-class" potentials. The clinical results of olverembatinib in hematologic malignancies have been selected for oral presentations at the American Society of Haematology (ASH) Annual Meetings for four consecutive years since 2018, and was nominated for "Best of ASH" in 2019. To date, olverembatinib has been granted three Orphan Drug Designations from the US FDA for the treatment of CML, ALL, and acute myeloid leukaemia (AML); and an Orphan Designation by the EU, for the treatment of CML. Dr. Yifan Zhai, chief medical officer of Ascentage Pharma, commented, "Overcoming drug resistance in the treatment of CML has long been an imperative for the global haematology community. This approval for the study of olverembatinib in Canada is indicative of the growing recognition of olverembatinib's potential efficacy and safety, and are the results of our continued global expansion. It is also an important milestone for the development and commercialization of this investigational drug. We will work full speed on the global clinical development of olverembatinib to allow more patients to benefit from this novel therapeutic as soon as possible." Ascentage Pharma is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases.

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