Ascentage Pharma submits first NDA for novel CML therapy
Suzhou-headquartered Ascentage Pharma has submitted its first-ever new drug application for regulatory approval.
The company put in the paperwork for its novel chronic myeloid leukemia treatment, HQP1351, to the NMPA.
Patients with chronic myeloid leukemia, or CML, have a genetic mutation in which parts of two chromosomes swap places to give rise to an abnormal BCR-ABL gene and its cancer-causing tyrosine kinase enzyme.
HQP1351 is a third-generation BCR-ABL tyrosine kinase inhibitor that targets BCR-ABL mutants in CML, including patients with T315I mutation. Patients with this mutation become resistant to first- and second-generation BCR-ABL inhibitors, such as Novartis’s Gleevec, and could benefit from Ascentage’s novel therapy.
The company used data from two pivotal Phase 2 studies to file its new drug application in China. In the U.S., HQP1351 is currently in Phase 1 development. The novel therapy was granted an orphan drug designation and fast-tracked by the Food and Drug Administration last month.
The company put in the paperwork for its novel chronic myeloid leukemia treatment, HQP1351, to the NMPA.
Patients with chronic myeloid leukemia, or CML, have a genetic mutation in which parts of two chromosomes swap places to give rise to an abnormal BCR-ABL gene and its cancer-causing tyrosine kinase enzyme.
HQP1351 is a third-generation BCR-ABL tyrosine kinase inhibitor that targets BCR-ABL mutants in CML, including patients with T315I mutation. Patients with this mutation become resistant to first- and second-generation BCR-ABL inhibitors, such as Novartis’s Gleevec, and could benefit from Ascentage’s novel therapy.
The company used data from two pivotal Phase 2 studies to file its new drug application in China. In the U.S., HQP1351 is currently in Phase 1 development. The novel therapy was granted an orphan drug designation and fast-tracked by the Food and Drug Administration last month.
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