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August 05, 2020 / / -- Merck Co) and Hanmi Pharma have jointly announced that they have signed an exclusive license agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), a weekly glutatrogen-like peptide-1 (GLP-1)/GGL) subject dual agonist developed by Hanmi for the treatment of non-alcoholic fatty hepatitis (NASH).
non-alcoholic fatty hepatitis (NASH) is an extreme form of development of non-alcoholic fatty liver disease, defined as the emergence of fatty degeneration accompanied by inflammation and liver cell damage.
NASH can lead to late-stage liver fibrosis, cirrhosis, liver failure, and liver tumors.
disease has become the second most common cause of liver transplantation in the United States after chronic hepatitis C.
NASH market has reached $40 billion, but no drugs have been approved to treat NASH.
efinopegdutide is a GLP-1/gluatic glutatrogen-like complex double-excited agent that activates both the GLP-1 and glutatroemia-likes.
the drug's safety and ability have been evaluated in several Phase 1 and Phase 2 clinical trials, including the treatment of severely obese patients with and without type 2 diabetes.
agreement, Mercadon will obtain exclusive license to develop, manufacture and commercialize efinopegdutide in the United States and around the world.
Hanmi will receive an advance of $10 million and will be eligible for milestone payments of up to $860 million related to the development, regulatory approval and commercialization of the efinopegdutide, as well as double-digit royalties based on product sales.
Hanmi reserves the option of commercializing efinopegdutide in South Korea.
Sam Engel, Vice President of Diabetes and Endocrinology Clinical Research, MercedOn Research Laboratory, said, "The data from Phase II provide compelling clinical evidence to support further evaluation of the treatment of NASH by efinopegdutide.
we will continue our proud tradition of developing meaningful drugs for metabolic diseases and look forward to driving the development of this candidate.
Chang Kwon, CEO and President of Hanmi, said, "This licensing agreement supports Hanmi's goal of developing and delivering innovative therapies to patients in need.
believe that Mercadon's strong scientific expertise in metabolic diseases enables it to better drive the development of this drug candidate and maximize its potential in patients around the world.
Origin: Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigation Once-Weekly Therapy for Nonalcoholic Steatohepatitis (NASH)