Hanmi Pharm Promotes 'Sintobuli Obesity Drug'... "Applying for Phase 3 Clinical Trial"

GLP-1 Inhibitor 'Epeglenaide'
From Diabetes Treatment to Obesity Therapy
Plans for 'Korean-Specific' Development

As new drugs demonstrating over 20% weight loss effects continue to emerge, Hanmi Pharmaceutical has officially entered the glucagon-like peptide-1 (GLP-1) market, which is becoming a new trend in obesity treatment.

Hanmi Pharm Research Center, Dongtan, Hwaseong-si, Gyeonggi [Photo by Hanmi Pharm]

Hanmi Pharmaceutical announced on the 31st that it submitted a clinical phase 3 trial plan (IND) to the Ministry of Food and Drug Safety on the 28th for adding obesity treatment indications to 'Epeglenatide.'

Epeglenatide was originally developed as a treatment for type 2 diabetes. It was licensed out to the global big pharma Sanofi in 2015, and various global phase 3 clinical trials were conducted. However, in 2020, the related rights were returned to Hanmi Pharmaceutical. Despite this, Sanofi presented the related results orally at the American Diabetes Association (ADA) in June 2021, one of the world's largest diabetes conferences, after the rights were returned, and the results were also published in the prestigious New England Journal of Medicine (NEJM), demonstrating the potential of Epeglenatide.

According to the 'AMPLITUDE-M' clinical trial results disclosed at the ADA, which involved 406 patients with type 2 diabetes whose blood sugar was not controlled by diet and exercise, significant weight loss was observed in the groups administered 4 mg and 6 mg of Epeglenatide over 56 weeks, and this effect was stably maintained for 56 weeks. Improvements in glycated hemoglobin and blood sugar control effects were also confirmed.

GLP-1 promotes insulin secretion and lowers blood sugar, so it was initially developed as a diabetes treatment. However, secondary effects such as appetite suppression in the brain and delayed gastric emptying have been confirmed, leading to its additional use as an obesity treatment. Currently, the obesity treatment market is led by Eli Lilly's 'Mounjaro (Tirzepatide),' Novo Nordisk's 'Saxenda (Liraglutide)' and 'Wegovy (Semaglutide),' all of which were first developed as GLP-1-based diabetes treatments before their obesity treatment efficacy was confirmed. Saxenda was originally launched as 'Victoza,' and Wegovy as 'Ozempic' for diabetes treatment, and these products were re-launched as obesity treatments.

As product launches continue, competition boasting higher weight loss levels is intensifying. After Mounjaro first demonstrated over 20% weight loss at 22.5% in clinical trials, Eli Lilly announced at this year's ADA that the triple agonist 'Retatrutide' showed a 24.2% weight loss effect in clinical results. Boehringer Ingelheim also revealed at the ADA that over 40% of participants in the phase 2 trial of 'Serduotide,' a GLP-1 agent co-developed with Zealand Pharma, achieved at least 20% weight loss.

However, Hanmi Pharmaceutical plans to develop Epeglenatide as a 'Korean-customized GLP-1' obesity drug optimized for the Korean obesity standard (body mass index (BMI) 25 kg/m²). A Hanmi Pharmaceutical official explained, “Global companies competitively announce superior weight loss percentages, but these figures may be beneficial mainly for Western patients with severe obesity,” adding, “As the first GLP-1 obesity drug developed through independent technology by a Korean pharmaceutical company, it is significant to develop a ‘Korean-customized obesity drug’ reflecting Korean body types and weights.” Given that extremely obese patients are not very common in Korea, where over 20% weight loss effects are being announced, such weight loss might be excessive. Therefore, Hanmi aims to create an obesity drug optimized for Koreans by considering weight loss effects and side effects.

Kim Nayoung, Executive Director of New Product Development at Hanmi Pharmaceutical, said, “We believe that Epeglenatide, optimized for Koreans, will be more competitive than foreign GLP-1 obesity drugs developed targeting Western patients with relatively higher BMI,” and added, “Since Epeglenatide’s potential has already been confirmed through large-scale global clinical trials, we will quickly proceed with clinical trials in Korea and aim to launch it domestically as soon as possible.”

Meanwhile, Hanmi Pharmaceutical is continuing to develop various new drugs based on GLP-1 analogs besides Epeglenatide. Hanmi’s ‘dual agonist,’ which combines GLP-1 with glucagon, was licensed out to MSD (Merck & Co., USA) and is currently undergoing a global phase 2b trial as a treatment for non-alcoholic steatohepatitis (NASH). Additionally, the triple agonist 'Triple Agonist,' which also acts on glucose-dependent insulinotropic polypeptide (GIP), is undergoing a global phase 2b trial targeting NASH.

This content was produced with the assistance of AI translation services.