NASH (non-alcoholic fatty hepatitis) treatment innovative drug developed by Hanmi Pharm and exported technology to MSD last year will receive the Korea New Drug Development Award for technology export.
Hanmi Pharm announced on Feb. 22 that one of its innovative bio-new drug pipelines, "Efinopegdutide (LAPSGLP/GCG)," will win the technology export award at the 22nd Korea New Drug Development Awards to be held on Feb. 26.
The award is hosted by the New Drug Development Research Association and sponsored by the Ministry of Health and Welfare and the Ministry of Science and ICT.
The Technology Export Award was reviewed and selected by the Korea New Drug Development Award Review Committee based on the technology level, value-added, competitiveness, and contribution to improving national health.
Choi In-young, executive director in charge of Hanmi Pharmaceutical's bio-new drug development, will participate in the award ceremony.
Efinopegdutide reached the weight loss target (proved more than two digits of weight loss effect), the primary evaluation index, in phase 2 of clinical trials after it was first licensed out to Janssen in 2015, but its rights were returned as the two companies disagreed over development adaptation.
However, Hanmi Pharm changed its certificate of adaptation in search of effective obesity reduction effect and signed a new license out contract with MSD in August last year as a treatment for non-alcoholic fatty hepatitis (NASH) worth $860 million.
This is considered an innovative case that reversed the atmosphere of the Korean pharmaceutical industry, which defines the return of technology exports as a failure to develop new drugs.
"It is a case of creating a reversal of innovation based on the accumulation of various experiences in the process of developing new drugs, and it is a meaningful achievement that has given another implication to the Korean pharmaceutical industry," said Choi In-young.
Efinopegdutide is a dual agent that simultaneously activates GLP-1 receptors that help with insulin secretion and appetite inhibition and glucagon that increases energy metabolism. It is applied with Labscovery technology, Hanmi Pharm's own platform technology.
The development of GLP-1 and Glucagon receptor dual agonists is a key to finding appropriate proportions of the two receptor activity.
Hanmi Pharm has secured its own mechanism and technology by developing substances into subcutaneous injections once a week for 11 years.
NASH, which exhibits complex symptoms of fatty liver, liver fibrosis, and liver inflammation, currently has no marketed treatment.
Efinopegdutide overcomes a single target, a limitation of existing drugs, and simultaneously interacts with intracranial fat, inflammation, and fibrosis, producing excellent clinical results in NASH patients. It is expected that the company will enter phase 2 of clinical trials this year.
Kwon Se-chang, CEO of Hanmi Pharm, said, " Efinopegdutide is one of the leading candidate substances for innovative new drugs in NASH, where there is no cure so far. We will work closely with our partners to quickly commercialize it based on special competitiveness."
