Licensed out to French pharmaceutical giant Sanofi in 2015 and returned five years later, Hanmi Pharmaceutical’s obesity drug candidate "EPPE" (efpeglenatide) has been kept alive through in-house perseverance. Originally developed as a diabetes therapy, the compound was repositioned as an obesity treatment and is now under regulatory review by South Korea’s Ministry of Food and Drug Safety (MFDS).
Hanmi Pharmaceutical announced on the 25th that it is documenting EPPE’s development history in a documentary-style brand film. The video features EPPE alongside follow-on obesity and metabolic candidates under its dedicated initiative, the "H.O.P" (Hanmi Obesity Pipeline) project, tracing its journey from rights return to its current marketing approval review.
From Sanofi Licensing to In-House Obesity Pivot
Efpeglenatide is a GLP-1 class therapy utilizing LAPSCOVERY, Hanmi Pharmaceutical’s proprietary long-acting drug platform technology. After its 2015 licensing deal, Sanofi conducted a global Phase 3 trial involving thousands of patients. However, following a strategic shift in R&D focus, Sanofi returned the rights in 2020. Hanmi clarified that the decision was not driven by concerns regarding efficacy or safety.
Leveraging previously secured clinical data and internal technology, Hanmi resumed in-house development, pivoting the drug toward obesity. The brand film features key leaders—including Hanmi Group Vice Chairperson Lim Ju-hyun, Vice President Choi In-young of the Future Growth Division, and Vice President Kim Na-young of the Innovative Growth Division—alongside project researchers, medical experts, and biotech analysts to detail EPPE’s development process and market significance.
Phase 3 Trial Demonstrates Up to 30% Weight Reduction
While awaiting regulatory approval, Hanmi completed a domestic Phase 3 trial involving 448 non-diabetic adult obesity patients. Interim 40-week results disclosed last year showed an average weight loss of 9.75% in the EPPE treatment group. Nearly half of the participants (49.46%) achieved at least 10% weight loss, 19.86% lost 15% or more, and maximum individual reductions reached 30.14%.
On Nov. 27 last year, the MFDS designated efpeglenatide for Global Innovative Product Fast Track (GIFT) review, and Hanmi formally applied for marketing authorization on Dec. 17. With approval targeted for the second half of this year, EPPE is set to become the first GLP-1 obesity treatment developed in-house by a South Korean pharmaceutical firm.
Cardiovascular Data and Next-Generation Pipeline
EPPE also benefits from extensive clinical data gathered during its initial diabetes trials. In the 4,076-patient AMPLITUDE-O study targeting type 2 diabetes patients at high cardiovascular risk, efpeglenatide demonstrated a 27% reduction in major adverse cardiovascular events and a 32% lower risk of composite kidney events compared to placebo. Results were published in The New England Journal of Medicine in 2021.
Additionally, Hanmi is conducting a domestic Phase 3 trial evaluating efpeglenatide in combination with metformin and the SGLT-2 inhibitor dapagliflozin for type 2 diabetes, with first-patient dosing initiated on April 13.
Beyond EPPE, Hanmi’s H.O.P project is advancing follow-on candidates focused on mitigating muscle loss or promoting muscle gain during weight reduction.
"EPPE is not simply a new drug; it is a legacy embodying the spirit of innovation built over decades at Hanmi," said Vice President Kim Na-young, overall head of domestic development for EPPE. "It reflects the philosophy of our late former Chairman Lim Sung-ki, who noted that a pharmaceutical company that does not develop new drugs is dead. We aim to build EPPE into a therapeutic option spanning broader metabolic diseases."
Hanmi Group Vice Chairperson Lim Ju-hyun noted that the company has always found new paths through challenge. "Through this documentary, we hope to convey Hanmi's dedication to R&D and our commitment to never giving up," Lim Ju-hyun said, adding that research is also underway to address supplementary care needs during weight loss.
Hanmi Pharmaceutical CEO Hwang Sang-yeon added, "As the nation's first GLP-1 obesity candidate targeted for launch this year, EPPE encapsulates our companywide capabilities. We hope this film shares the true value of our journey with both the public and our employees."
