HQP1351 Granted FDA Orphan Drug Designation for Treatment of Chronic Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted HQP1351 orphan drug designation for the treatment of chronic myeloid leukemia (CML).

HQP1351 is an orally active, potent third-generation BCR-ABL inhibitor, that targets BCR-ABL mutations, including T315I which is found in approximately 25% of patients first- and second.

HQP1351 is currently being evaluated in a Phase 2 study.

“There is significant unmet clinical need in the treatment of CML globally. This ODD from FDA marks a major milestone for HQP1351 which will bring about the incentives and support that will enable us to further accelerate the global development and commercialization of this drug candidate,” said Dr Dajun Yang, Chairman & CEO of Ascentage Pharma, in a press release “Given the favorable safety and efficacy data obtained thus far, we will expedite the development and are hopeful that HQP1351 will soon benefit patients worldwide.”

Read the full press release here.