Hanmi Pharmaceutical's New Drug 'Labstreeple Agonist' Designated as FDA Orphan Drug

Hanmi Pharmaceutical Headquarters (Photo by Hanmi Pharmaceutical)

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's biopharmaceutical 'LAPSTriple Agonist (HM15211)' has been additionally designated as an orphan drug by the U.S. Food and Drug Administration (FDA).

Hanmi Pharmaceutical announced on the 12th that the FDA designated LAPSTriple Agonist as an orphan drug for the treatment of idiopathic pulmonary fibrosis (IPF) on the 10th.

LAPSTriple Agonist was also designated as an orphan drug by the FDA in March last year for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). In July, it received fast track designation from the FDA for the development of a treatment for non-alcoholic steatohepatitis (NASH), and development is progressing with close consultation and support from the FDA at each stage.

With this designation, Hanmi Pharmaceutical now holds a record of 17 orphan drug designations (9 from the FDA, 5 from the European Medicines Agency (EMA), and 3 from the Korean Ministry of Food and Drug Safety) across 6 pipelines and 10 indications. This is the highest number among domestic pharmaceutical companies.

The orphan drug designation system by the FDA supports the development and approval of treatments for rare, intractable, or life-threatening diseases. It provides various benefits such as tax reductions, exemption from application fees, and 7 years of market exclusivity upon first approval among products of the same class.

The newly designated idiopathic pulmonary fibrosis is a rare disease in which fibroblasts excessively proliferate during an unknown cause of lung inflammation, causing fibrosis of lung tissue, leading to rapid deterioration of lung function and potentially death in severe cases. It occurs in fewer than 100 cases per 100,000 people annually and causes symptoms such as difficulty breathing that make daily life challenging, but there is no effective treatment other than symptomatic therapy.

LAPSTriple Agonist is a triple agonist that simultaneously activates GLP-1, glucagon, and GIP receptors. It targets glucagon, which directly inhibits fibrosis, and GLP-1 and GIP, which promote insulin secretion and have anti-inflammatory effects, providing therapeutic effects on both inflammation and fibrosis.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "LAPSTriple Agonist, which has shown meaningful effects in complex liver diseases such as NASH, has now been recognized by the FDA for its potential in lung diseases as well. We will do our best to commercialize it quickly for patients suffering from inflammation and fibrosis, where there is a high unmet medical need."

This content was produced with the assistance of AI translation services.