China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). The drug is being developed for use in combination with venetoclax and/or azacitidine, offering potential new treatment options for patients.
Preliminary Findings and Safety Profile of QHRD107
Preliminary findings indicate that the QHRD107 capsule, an oral cyclin-dependent kinase (CDK) 9 inhibitor, is safe in AML patients with a controllable overall risk. A Phase I clinical study has successfully established a recommended dose for the Phase II stage, paving the way for further investigation into the drug’s efficacy and safety.
Monotherapy Potential and Antileukemia Activity
As a monotherapy, QHRD107 has demonstrated certain anti-leukemia activity, suggesting that certain AML patients may benefit from the drug. The advancement to a Phase II trial marks a significant step in the development of QHRD107, which could potentially improve treatment outcomes for individuals with AML.-Fineline Info & Tech
