Hanmi Pharmaceutical said it has entered into an exclusive licensing agreement with MSD to develop, manufacture, and commercialize its LAPSGLP/Glucagon receptor dual agonist as the treatment of non-alcoholic steatohepatitis (NASH).

The international nonproprietary name of LAPSGLP/Glucagon receptor dual agonist is efinopegdutide, and it was called with a code name HM12525A.

The LAPSGLP/Glucagon receptor dual agonist is a double-acting treatment that activates both glucagon-like peptide-1 (GLP-1), which helps secrete insulin and suppress appetite, and glucagon, which increases metabolism. Hanmi’s long-acting drug delivery technology LAPSCOVERY is applied to the therapy.

Under the agreement, the U.S.-based MSD will be granted exclusive rights to develop, manufacture, and commercialize efinopegdutide globally except for Korea.

Hanmi will receive an upfront payment of $10 million and milestone payments up to $860 million linked to the phased clinical development, regulatory approval, and commercialization of efinopegdutide. The company will also receive double-digit sales royalties after launching the product.

“The phase 2 clinical data of efinopegdutide provides a compelling clinical basis for this drug candidate to be developed as a NASH treatment,” said Director Sam Engel at MSD Clinical Research Center of Diabetes and Endocrinology. “We will continue to fulfill our mission of developing the candidate material and meaningful treatment for metabolic disease.”

Hanmi Pharmaceutical CEO Kwon Se-chang said, “This agreement is significant because the candidate material, which was developed as a new drug for the treatment of obesity and diabetes, was recognized for its potential to expand into therapeutic agents for chronic metabolic diseases, including NASH.”