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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