Hanmi Pharmaceutical’s New Biologic Receives Another Orphan Drug Designation from US FDA


LAPS-Triple Agonist (HM15211), a new bio drug from Hanmi Pharmaceutical, has received another orphan drug designation from the US FDA.

According to the company, the FDA designated LAPS-Triple Agonist as an orphan drug for treatment of idiopathic pulmonary fibrosis (IPF).

The triple-acting new drug activates GLP-1 receptors, glucagon receptors, and GIP receptors. Glucagon, in particular, directly suppresses fibrosis, while GLP-1 and GIP, on the other hand, are involved in insulin secretion and anti-inflammatory response. As such, the drug has efficacy against inflammation and fibrosis. Hanmi Pharmaceutical has demonstrated the anti-inflammatory and anti-fibrosis effects of LAPS-Triple Agonist against in animal models with pulmonary fibrosis.

LAPS-Triple Agonist was designated as an orphan drug by the FDA for the first time for treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC) in March last year. Last July, it received the FDA Fast Track designation for development as a therapeutic agent for nonalcoholic steatohepatitis (NASH), thereby receiving assistance from the FDA to speed up the development process. As a result of the most recent orphan drug designation, Hanmi Pharmaceutical now has 17 orphan drug designations (9 from the FDA, 5 from the EMA, and 3 from the MFDS of Korea) for 10 indications with respect to 6 pipelines. This is the largest record held by a Korean pharmaceutical company.

The FDA’s Orphan Drug Designation program facilitates the development and approval of therapeutic agents for rare, intractable, or life-threatening diseases. A wide range of benefits is afforded, such as tax cuts, waiver of application fees, and seven-year market exclusivity.

IPF, for which the orphan drug designation was granted, is a rare condition in which fibrosis in the lung tissue is caused by excess proliferation of fibrocytes in the lung due to inflammation, the cause of which is unknown, and as a result, the lung function deteriorates rapidly and it may even lead to death. It occurs in no more than 100 out of every 100,000 individuals in the population each year. It is accompanied by symptoms that present challenges in everyday activities, such as shortness of breath, but there are no effective treatments at present, except for symptomatic therapy.

Kwon Se-chang, Co-President and Co-CEO of Hanmi Pharmaceutical, said, “LAPS-Triple Agonist, which demonstrated significant effectiveness against a number of liver diseases, has been recognized for its potential as a treatment for lung disease from the FDA. We will do our best to commercialize the product as soon as possible for patients who are suffering from inflammation and fibrosis, medical conditions for which treatment demand is high.”

Source: Financial News