Hanmi’s NASH candidate gains FDA orphan drug status for sclerosing cholangitis - (Pulse via NewsPoints Desk)

  • Hanmi Pharmaceutical said it has gained an FDA orphan drug designation for its non-alcoholic steatohepatitis drug candidate HM15211 for the treatment of primary sclerosing cholangitis, reported Pulse.

  • According to the company, HM15211 has multiple pharmacological activities that stimulate GLP-1, glucagon and GIP receptors simultaneously, reducing excessive hepatic bile acid accumulation and inhibiting liver inflammation and fibrosis.

  • Hanmi has so far obtained nine molecules in its pipeline designated as orphan drugs by the FDA or the European Medicines Agency (EMA), said CEO Kwon Se-chang.

  • He added that the company "will go all out" to bring the drug quickly to the market to meet the unmet needs of rare-disease patients.

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