Hanmi's First Domestic GLP-1 Obesity Drug to Expand as Diabetes Treatment

Hanmi Submits IND Application to MFDS
for Phase 3 Clinical Trial of Efeglenatide Combined with SGLT2 Inhibitor

Hanmi Pharmaceutical's "Efeglenatide," the first domestically developed GLP-1 (glucagon-like peptide-1) obesity treatment in Korea, is set to expand its indications to include diabetes treatment through combination clinical trials with SGLT2 inhibitors.

On September 30, Hanmi Pharmaceutical announced that it had submitted a phase 3 clinical trial plan (IND) to the Ministry of Food and Drug Safety to evaluate the blood glucose control efficacy of combination therapy with Efeglenatide, an SGLT2 inhibitor, and metformin in patients with type 2 diabetes.

Seoul Songpa-gu Hanmi Pharmaceutical Headquarters. Hanmi Pharmaceutical

Efeglenatide is a long-acting GLP-1 class therapy based on Hanmi Pharmaceutical's proprietary platform technology, "LAPSCOVERY." The technology was licensed out to Sanofi in 2015 for global development as a diabetes treatment. After the rights were returned in 2020, Hanmi Pharmaceutical continued its own development, rapidly expanding clinical trials as a Korean obesity treatment.

Hanmi Pharmaceutical has conducted various independent clinical trials of Efeglenatide to date. Previously, in collaboration with Sanofi, the company conducted a large-scale global phase 3 clinical trial involving 6,000 patients with type 2 diabetes, confirming its potential as a diabetes treatment.

Currently, Hanmi Pharmaceutical has completed the enrollment of 448 participants in a phase 3 clinical trial for adult obesity patients in Korea and plans to continue combination clinical trials with SGLT2 inhibitors and metformin for diabetes patients.

Efeglenatide has demonstrated not only weight loss effects but also clinical evidence of reducing the incidence of cardiovascular and renal diseases. Related research findings have been published in several leading international journals, including the New England Journal of Medicine (NEJM) and Circulation.

Through this phase 3 clinical trial of SGLT2 inhibitor/metformin combination therapy, Hanmi Pharmaceutical aims to prove the blood glucose control efficacy of Efeglenatide and confirm its potential as an integrated metabolic disease treatment encompassing obesity, cardiovascular disease, and kidney disease management.

Kim Nayoung, Executive Vice President and Head of New Product Development at Hanmi Pharmaceutical, stated, "Efeglenatide is an innovative new drug with the potential to expand its therapeutic scope beyond obesity to various metabolic diseases, including diabetes, cardiovascular, and kidney diseases. Through this phase 3 clinical trial, we aim to provide patients with broader treatment opportunities and achieve globally recognized innovative results."

Meanwhile, Hanmi Pharmaceutical plans to complete the domestic phase 3 obesity clinical trial of Efeglenatide in the second half of this year and aims for domestic market launch in the second half of next year. Efeglenatide will be produced at Hanmi Pharmaceutical's state-of-the-art biopharmaceutical production facility, the Pyeongtaek Smart Plant, ensuring stable and continuous supply to patients.

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