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Hanmi’s acute myeloid leukemia wins developmental stage orphan drug status
  • By Lee Han-soo
  • Published 2019.03.05 15:34
  • Updated 2019.03.05 15:34
  • comments 0

The Ministry of Food and Drug Safety has granted Hanmi’s HM43239, a treatment for acute myeloid leukemia (AML), as Korea’s 22nd developmental stage orphan drug status.

Hanmi headquarters in Bangi-dong, eastern Seoul.

AML is a blood cancer that abnormally increases white blood cells, while HM43239 is a second-generation anti-cancer drug that inhibits the FMS-like tyrosine kinase 3 (FLT3) gene mutations. FLT3 intervenes in dendritic cell growth and differentiation and by inhibiting the gene it can induce apoptosis.

The company’s treatment has received attention after confirming that the FLT3 gene is the primary cause of AML. According to the company, about 30 percent of all patients develop the mutation.

The company expects HM43239 will meet the unfulfilled medical need to overcome FLT3 inhibitor resistance and suppressing gene mutation.

The U.S. Food and Drug Administration also granted orphan drug status to the drug last October. The company is now conducting phase 1 and 2 clinical trials in Korea and plans to present the pre-clinical trial results of the drug during the 2019 American Association for Cancer Research conference on March 31.


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