Hanmi’s Innovative New NASH Drug Wins the Technology Export Award at the Korea New Drug Awards


For the development of a novel, innovative drug to treat patients with nonalcoholic steatohepatitis (NASH) and for the drug development technology export to a major U.S. pharmaceutical company, Merck Sharp & Dohme Corp. (MSD), last year, Hanmi Pharmaceutical is going to receive the Technology Export Award at the Korea New Drug Awards (KNDA).

The announcement was made on February 22nd by Hanmi Pharm (President/CEO Se-Change Kwon and Jong-Soo Woo) that the company would receive the Technology Export Award for one of its innovative, novel biological drug pipeline candidates, Epinofegdeutide (LAPSGLP/GCG), at the Korea New Drug Awards (KNDA) ceremony to be held on February 26th.

The awards ceremony is hosted by the Korea Drug Development Research Association (KRDA) and sponsored by both the Ministry of Health and Welfare and the Ministry of Science and ICT. The Technology Export Award was selected by the KNDA Award Review Committee based on the technology level, added value, competitiveness, and contribution to national health improvement of the new drug candidate. Hanmi Pharmaceutical’s Executive Director In Young Choi is going to participate in the awards ceremony on behalf of the company.

Epinofegdeutide reached the weight loss target (proving its effectiveness in double-digit weight loss), the preliminary assessment indicator, in Phase II Clinical Trials conducted after the first Out-license of the candidate to Janssen in 2015, but the rights were returned as the two companies exhibited disagreement over the indications for development.

However, Hanmi Pharm changed the indication in search of the weight-loss effects, developed it as a treatment for non-alcoholic steatohepatitis (NASH), and signed a new Out-license contract worth $860 million (about ₩1 trillion) with MSD last August. This was recognized as a case of innovation that reversed the atmosphere of the Korean pharmaceutical industry, which defines the return of technology exports as new drug development failure.

Executive Director In Young Choi said, "It was a case of creating a reversal of innovation based on the accumulation of various experiences during the process of developing new drugs. I think it was a meaningful achievement that gave another implication to the Korean pharmaceutical industry. We will use this as an opportunity to unwaveringly devote ourselves to R&D to create globally innovative new drugs."

Epinofegdeutide is a dual agonist that simultaneously activates GLP-1 receptors that help secrete insulin and suppress appetite, as well as glucagon, which increases energy metabolism. Hanmi Pharmaceutical's proprietary platform technology, LAPSCOVERY, was applied to it.

The development of the GLP-1/glucagon receptor dual agonist is key to finding the correct ratio of the two receptor activities. Hanmi has secured its own mechanism of action and technology by developing once-weekly subcutaneous injections for 11 years, starting with substance exploration in 2010.

There is currently no commercially available treatment for NASH, which exhibits a combination of fatty liver, liver fibrosis, and hepatitis. Epinofegdeutide overcomes a single target, a limitation of existing drugs, and simultaneously acts on intrahepatic fat, inflammation, and fibrosis. It has produced excellent clinical results in patients with NASH. It is expected to enter Phase II Clinical Trials this year.

President/CEO Se-Change Kwon said, "Epinofegdeutide is one of the leading, innovative, novel NASH drug candidates in a field where there are currently no other approved treatments. We will cooperate closely with our partners to ensure rapid commercialization based on its unique competitiveness showing excellent efficacy and effectiveness against inflammation and fibrosis.”

Source: Medipana News