Hanmi Pharmaceutical's NASH Treatment to Accelerate Development Timeline in the US

US FDA Designates Hanmi's Innovative NASH Treatment Drug for Fast Track

[Asia Economy Reporter Choi Dae-yeol] Hanmi Pharmaceutical announced on the 16th that its 'Rhaps Triple Agonist,' being developed as a treatment for non-alcoholic steatohepatitis (NASH), has been designated as a Fast Track by the U.S. Food and Drug Administration (FDA).

The drug is currently undergoing global Phase 2 clinical trials as an innovative new drug, and with this Fast Track designation, its development can proceed more rapidly. The FDA designates drugs as Fast Track when they demonstrate superior efficacy for serious or life-threatening diseases and require expedited development. According to the company, this designation allows for full support from the FDA at each stage of development and closer consultation.

This new drug is a triple (glucagon, GIP, GLP-1) agonist, applying Hanmi Pharmaceutical's proprietary platform technology called Rhapscovery. Among its components, glucagon directly reduces fatty liver and suppresses fibrosis. At the same time, GLP-1, which aids insulin secretion and appetite suppression, and GIP, which promotes insulin secretion and has anti-inflammatory effects, are simultaneously activated to treat fatty liver, inflammation, and fibrosis concurrently.

In the U.S., Europe, and other regions, NASH is considered a complex disease with no approved treatments, and the approval requirements are stringent. Many global pharmaceutical companies have failed during clinical development stages because they could not demonstrate therapeutic efficacy. Hanmi Pharmaceutical expects that if the drug is ultimately commercialized, it could lead the NASH treatment market, which is worth tens of trillions of won. Kwon Se-chang, CEO of Hanmi Pharmaceutical, stated, "The Fast Track designation has accelerated the development and commercialization process."

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