Hanmi Pharm Records Twenty Orphan Drug Designations Among First-in-Class Drugs Under Development


Hanmi Pharmaceutical has recorded 20 orphan drug designations among the first-in-class drugs currently under development, setting a new record in the domestic pharmaceutical and bio industry.

Hanmi Pharm (co-CEOs Kwon Se-chang and Woo Jong-soo) announced on June 9 that the European Medicines Agency (EMA) had approved its triple-acting biologic called LAPSTriple Agonist (HM15211) as an orphan drug for treatment of idiopathic pulmonary fibrosis (IPF).

As a result, Hanmi Pharm holds 20 orphan drug designations (9 designations by the US FDA, 8 by the EMA, and 3 by the Korean Ministry of Food and Drug Safety) for 6 pipelines for 10 indications. Among them, LAPSTriple Agonist has received six orphan drug designations from the FDA and EMA for primary biliary cholangitis, primary sclerosing cholangitis, and idiopathic pulmonary fibrosis.

The FDA and EMA’s orphan drug designation system is aimed at facilitating development and approval of treatments for rare, intractable, or life-threatening diseases. In Europe, benefits include a reduced fee for applying for approval and an exclusive right to sell products of the same class for 10 years from the date of the initial marketing approval.

IPF, an indication designated by the EMA for Hanmi’s new drug, is a rare, life-threatening disease that causes a rapid decline in lung function due to tissue fibrosis resulting from an unknown inflammatory process and hyperproliferation of fibroblasts in the lung. It occurs in fewer than 100 in 100,000 people each year, and existing treatments lacked efficacy.

LAPSTriple Agonist is a triple-acting agonist that activates GLP-1 receptors, glucagon receptors, and GIP receptors at the same time. That is, it targets glucagon that suppresses fibrosis, GLP-1 that promotes insulin secretion and suppresses appetite, and GIP with insulin secretion and anti-inflammatory effects. Hanmi Pharm has confirmed the anti-inflammatory and anti-fibrotic effects of LAPSTriple Agonist in an animal model with IPF.

“All indications for which [LAPSTiple Agonist] received the orphan drug designation are a major field of diseases that cause fibrosis of specific tissues and that has significant unmet medical needs. […] This is meaningful in that LAPSTiple Agonist’s innovativeness has caught the attention of regulatory bodies in developed countries.”

Source: Bokuen News (Health News)