Indications: chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST)
HQP1351 is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML.
HQP1351 finished pivotal phase II studies in China and was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. A New Drug Application (NDA) of HQP1351 has submitted in June, 2020. In May 2020, HQP1351 was granted an Orphan Drug Designation and a Fast Track Designation by the US FDA. Besides, HQP1351 has entered the clinical trials for GIST in China.