Hanmi Pharm's 'Labstreeple Agonist' Designated as EMA Orphan Drug

[Asia Economy Reporter Chunhee Lee] Hanmi Pharmaceutical's triple-action biopharmaceutical 'Labstiple Agonist (HM15211)' has been additionally designated as an orphan drug by the European Medicines Agency (EMA).

Hanmi Pharmaceutical announced on the 10th that EMA recently designated Labstiple Agonist as an orphan drug for the treatment of primary biliary cholangitis (PBC).

Labstiple Agonist had previously received orphan drug designation from the U.S. Food and Drug Administration (FDA) for three indications and had also been designated as an orphan drug by EMA for primary sclerosing cholangitis, making this its fifth designation. This is the highest number of orphan drug designations received by a new drug developed by a domestic pharmaceutical company. For PBC and primary sclerosing cholangitis, orphan drug designations were received from both the FDA and EMA, and the FDA also granted orphan drug designation for the treatment of idiopathic pulmonary fibrosis.

With this, Hanmi Pharmaceutical has received a total of 19 orphan drug designations for 10 indications across 6 pipelines. This includes 9 from the FDA, 7 from the EMA, and 3 from the Korean Ministry of Food and Drug Safety, marking the highest record among domestic pharmaceutical companies.

The orphan drug designations by the FDA and EMA are systems that support the development and approval of treatments for rare, intractable, or life-threatening diseases. In Europe, various benefits are provided, such as reduced application fees and a 10-year market exclusivity period granted upon the first marketing authorization approval within the same product class.

PBC, an autoimmune disease, is a chronic progressive cholestatic liver disease caused by unknown inflammation and fibrosis of the intrahepatic bile ducts. The bile ducts are gradually destroyed, leading to bile duct obstruction and liver tissue damage, and in severe cases, liver transplantation may be required.

Labstiple Agonist is a triple agonist that simultaneously activates GLP-1 receptors, glucagon receptors, and GIP receptors. Based on its multi-pharmacological effects, it is expected to significantly improve the quality of life for patients with various autoimmune liver diseases by reducing excessive hepatic bile acid accumulation and suppressing liver inflammation and fibrosis.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, “Labstiple Agonist continues to secure meaningful potential across various indications,” and added, “We will do our best to develop and commercialize Labstiple Agonist to improve the quality of life for patients suffering from rare diseases.”

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