Hanmi Pharmaceutical's HM43239 anti-cancer drug wins FDA designation

Lim Chang-won Reporter Posted : 2018-10-31 10:17 Updated : 2018-10-31 10:17
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[Courtesy of Hanmi Pharmaceutical]

SEOUL -- HM43239, a new anti-cancer drug developed by South Korea's leading drug maker Hanmi Pharmaceutical, has won a special designation from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia.

Hanmi said that it would begin HM43239's clinical trials in the near future at the MD Anderson Cancer Center in Houston. HM43239 is a therapy candidate for the treatment of acute myeloid leukemia (AML), a relatively rare and fast-growing malignant disease.

FDA's Orphan Drug Designation (ODD) is granted to drugs intended for the safe and effective treatment of rare diseases and disorders that affect fewer than 200,000 people in the United States. The ODD status provides certain benefits including a tax reduction.

HM43239 is designed to inhibit mutations in the FMS-like tyrosine kinase 2 gene, a marker which appears in approximately one-third of all AML patients. While such therapies have emerged as a target-based alternative to traditional chemotherapy, Hanmi said it has overcome drug resistance found in other meds.