Hanmi Pharm's Innovative NASH Treatment Drug Wins Korea New Drug Development Award for Technology Export

Hanmi Pharmaceutical Headquarters (Provided by Hanmi Pharmaceutical)

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharm's innovative new drug for NASH (non-alcoholic steatohepatitis), developed and licensed out to MSD in the United States last year, has been honored with the Technology Export Award at the Korea New Drug Development Awards.

Hanmi Pharm announced on the 22nd that at the '22nd Korea New Drug Development Awards' ceremony to be held on the 26th, 'Epinofpegdutide (LAPSGLP/GCG),' one of Hanmi Pharm's innovative biopharmaceutical pipelines, will receive the Technology Export Award.

The Korea New Drug Development Awards are hosted by the New Drug Development Research Association and supported by the Ministry of Health and Welfare and the Ministry of Science and ICT. Among the awards, the Technology Export Award is selected based on criteria such as the technological level of the new drug candidate substance, added value, competitiveness, and contribution to improving public health.

Epinofpegdutide initially licensed out to Janssen in 2015 reached the primary endpoint of double-digit weight loss in the Phase 2 clinical trial. However, the rights were returned due to disagreements between the two companies regarding the development indications.

Nevertheless, Hanmi Pharm found an effective obesity reduction effect and changed the indication, then newly signed a license-out contract with MSD in the United States in August last year for NASH treatment worth $860 million (approximately 953 billion KRW). This is regarded as an innovative case that reversed the atmosphere in the Korean pharmaceutical industry, which tends to define technology export returns as new drug development failures.

Choi In-young, Executive Director in charge of Hanmi Pharm's biopharmaceutical development, said, "I consider this a meaningful achievement as a case that created a turnaround innovation based on the accumulation of various experiences during the new drug development process, providing another implication for the Korean pharmaceutical industry," adding, "We will take this as an opportunity to steadfastly pursue research and development (R&D) to create global innovative new drugs."

Epinofpegdutide is a dual agonist that simultaneously activates the GLP-1 receptor, which helps insulin secretion and appetite suppression, and glucagon, which increases energy metabolism. It applies Hanmi Pharm's proprietary platform technology, LAPSCOVERY.

NASH, which shows complex symptoms of fatty liver, liver fibrosis, and liver inflammation, currently has no approved treatments on the market. Epinofpegdutide overcomes the limitations of existing drugs that target a single target by simultaneously acting on liver fat, inflammation, and fibrosis, demonstrating excellent clinical results in NASH patients. It is expected to enter Phase 2 clinical trials this year.

Kwon Se-chang, CEO of Hanmi Pharm, said, "Epinofpegdutide is one of the most advanced innovative new drug candidates in the NASH field, where there are currently no treatments," adding, "Based on its special competitiveness showing excellent efficacy in inflammation and fibrosis, we will closely cooperate with our partners to rapidly commercialize it."