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FDA fast-tracks Hanmi’s liver disease drug

Hanmi Pharmaceutical
Hanmi Pharmaceutical
Hanmi Pharmaceutical’s LAPS Triple Agonist (HM15211) was given fast-track approval by the US Food and Drug Administration, the company announced Thursday.

LAPS Triple Agonist is Hanmi’s original pipeline for a form of nonalcoholic fatty liver disease commonly called NASH for short. NASH is one of the most common incurable diseases that has high unmet medical needs.

Current drugs only slow the progression of the disease, which can cause death due to scarring of the liver, but cannot reverse it.

With the FDA’s fast-track designation, Hanmi anticipates faster administrative procedures for the pipeline’s development.

Hanmi’s HM15211 pipeline uses the company’s lapscovery platform technology to bind three therapeutic agents: glucagon, GIP and GLP-1.

Glucagon directly reduces fatty liver and inhibits scarring. GLP-1 helps release insulin and suppresses the appetite, and GIP helps release insulin and brings down the level of inflammation.

Hanmi believes that should its HM15211 succeed in development, it will become a game changer and lead the NASH drug market, which is worth trillions of won.

The pipeline is currently undergoing global phase 2 clinical trials.

In most patients who took HM15211, the pipeline reduced their fatty liver disease by 50 percent within three months, Hanmi said at the American Diabetes Association’s online gathering in June.

By Lim Jeong-yeo (
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Korea Herald daum