Hanmi Pharma GLP-1 drug to get edge in South Korea obesity market due to local trials, says GlobalData

The Korean Ministry of Food and Drug Safety (MFDS) has recently given clearance to Hanmi Pharmaceutical to conduct Phase III trial for its Korean-optimized obesity candidate efpeglenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Against this backdrop, efpeglenatide is expected to get an edge in the domestic obesity market due to local trials, says GlobalData, a leading data and analytics company.

As per the Korean Society for the Study of Obesity (KSSO), the initial treatment for obesity includes non-pharmacotherapy like diet, exercise, and behavioral therapy. The pharmacotherapy should be given in combination with non-pharmacotherapies, only for Korean adults with a BMI of 25 kg/m² or higher. So far, non-peptide anti-obesity medications (AOMs) (Orlistat, Contrave, Qsymia) and GLP-1 AOMs (Saxenda and Wegovy) are approved in South Korea.

According to GlobalData Pharma Intelligence Center, the number of total diagnosed prevalent cases of obesity in South Korea is expected to grow at an annual growth rate (AGR) of 0.69%, increasing from 12 million cases in 2022 to 13 million cases in 2031.

Sowmya Chandrakumar, Pharma Analyst at GlobalData, comments: “The global obesity prevalence is increasing rapidly. Therefore, there is a huge demand for drugs that offer greater weight loss with fewer adverse events, easy administration, stable supply, and are cost-effective.”

The investigational new drug application for the Phase III multi-center trial, aiming to enroll 420 obese patients without T2D, and projected to conclude by 2026, was submitted to MFDS in July 2023. The review was expedited through multiple programs along the “Global Innovative products on Fast Track” (GIFT) system, which drives close communication with regulatory authorities, pre-resolving potential issues before hand.

Efpeglenatide was licensed by Hanmi to Sanofi in 2015 and later Sanofi returned rights to Hanmi in June 2020, after conducting five global Phase III studies with T2D patients. The results showed robust weight loss, blood sugar control, improvements in cardiovascular and kidney diseases.

Chandrakumar adds: “The Korean-optimized efpeglenatide will get an edge, as the foreign GLP-1 obesity drugs were developed for high BMI levels as per western patient-based standards.”

Efpeglenatide is given as a weekly or bi-weekly injection. The Phase II evaluation showed significant body weight loss of ≥5% or ≥10%, improved glycaemic and lipid variables. In comparison, GLP-1 AOMs, namely Novo Nordisk’s Saxenda and Wegovy, that are doing well in Korea and administered with daily or weekly injections, showed weight loss of 7% or 15%, respectively. Due to the upsurge of AOMs market, these might face short supply globally.

Chandrakumar concludes: “The proven results for GLP-1 drugs for obesity has resulted in increased market demand. Efpeglenatide approval could emerge as the primary option for Korean obese patients due to local manufacturing, ensuring cost-effectiveness and a consistent supply.”

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