Hanmi Pharmaceutical has issued guidance aimed at providing accurate drug information and ensuring safe use, following domestic product approval for 'Effe' (ingredient name: epeglenatide), a GLP-1 class obesity treatment it developed in-house.

Safe Use Guidance Issued After Approval

According to a notice posted on Hanmi Pharmaceutical's website, the company provides accurate drug information to medical professionals in compliance with relevant laws and approval conditions for all prescription drugs. Detailed product information can be found in the product information section of the official website, and the company recommends consulting with a medical professional for proper use.

This guidance comes after Hanmi Pharmaceutical received marketing authorization for Effe from the Ministry of Food and Drug Safety on the 7th, at a time when a new competitive landscape is forming in the domestic obesity treatment market.

What Is Effe? A GLP-1 Obesity Treatment Developed with In-House Technology

Effe is a GLP-1 class obesity treatment developed by Hanmi Pharmaceutical entirely with its own technology, from candidate discovery through clinical development and production. It incorporates LAPSCOVERY, the company's proprietary long-acting drug efficacy platform technology, and data on weight loss efficacy and safety were secured through clinical trials conducted on Korean patients with obesity.

According to interim 40-week Phase 3 results released by the company, the average weight reduction rate in a trial involving 448 Korean patients with obesity was 9.75%. Patients who lost 5% or more of their body weight accounted for 79.42% of the Effe treatment group, those who lost 10% or more accounted for 49.46%, and those who lost 15% or more accounted for 19.86%. However, these figures are results observed in clinical trials, and actual treatment effects may vary depending on the patient's condition and treatment circumstances.

Production at Pyeongtaek Bio Plant; Research Underway to Expand into Diabetes

Hanmi Pharmaceutical has established a system to produce Effe from raw materials to finished products at its Pyeongtaek bio plant. Through this, the company aims to secure a domestic supply base and strengthen its competitiveness in a market dominated by imported obesity treatments.

Research is also underway to expand Effe beyond obesity treatment into the diabetes treatment area. In May, Hanmi Pharmaceutical announced that it had administered the first dose to a patient in a domestic Phase 3 trial evaluating combination therapy of epeglenatide with an existing diabetes treatment. The study aims to confirm the blood glucose control efficacy and safety in patients with type 2 diabetes.

How to Check Safe Use Information; Physicians' Judgment Is Key

Meanwhile, Hanmi Pharmaceutical noted that information on the safe use of GLP-1 class obesity treatments can also be found in the 'Education and Publicity' archive on the website of the Korea Institute of Drug Safety and Risk Management. As GLP-1 class treatments are prescription drugs used for weight management, the judgment of medical professionals, taking into account individual health status, underlying conditions, and concomitant medications, is essential.

Hanmi Pharmaceutical's guidance is interpreted as emphasizing not only therapeutic efficacy but also the importance of accurate drug information and appropriate use, in line with the new drug's approval and commercialization preparations. Going forward, Effe's success in settling into the domestic market is expected to be influenced by its actual launch schedule, supply stability, price competitiveness, and the expansion of prescriptions in clinical settings.

[This article was written based on Hanmi Pharmaceutical's official announcements and the guidance posted on its website. The efficacy and safety of drugs may vary by individual, and the use of prescription drugs must be discussed with a medical professional. AI assistance was used in the writing of this article.]