Hanmi Pharmaceutical said on the 5th that "efeglenatide," a Korea-tailored obesity treatment it is developing, has been designated by the Ministery of Food and Drug Safety as subject to the "Global Innovative product Fast Track (GIFT)" support system.
Launched in September 2022, GIFT is a system that expedites review so that global innovative therapies, for which there are no adequate treatments or where medical improvement is unlikely, can be commercialized quickly, accelerating their market launch. Once designated under GIFT, reviews proceed on a schedule about 25% shorter than general reviews through measures such as assigning a dedicated review team, tailored reviews, and priority review.
Efeglenatide is a glucagon-like peptide (GLP)-1 obesity drug candidate independently developed by Hanmi Pharmaceutical. In a phase 3 study of 448 adult patients with obesity without diabetes who received the drug, patients showed up to 30% weight loss at week 40 of dosing. Gastrointestinal adverse events were lower than or mild compared with existing GLP-1 obesity drugs.
At week 40, the mean weight loss rate in the efeglenatide group was 9.75%, demonstrating statistically significant superiority over placebo. Notably, among female patients with a body mass index (BMI, weight divided by height squared) under 30 kg/㎡, an average weight loss of 12.20% was observed. The maximum weight loss reached 30.14%.
Efeglenatide also showed significant improvements versus placebo in BMI, waist circumference, glucose measures (hemoglobin A1c, fasting glucose, fasting insulin), lipid markers (total cholesterol, triglycerides, non-HDL cholesterol), and blood pressure, indicating overall metabolic improvement.
The company is additionally conducting a 24-week extension study and plans to assess the durability of weight loss with long-term dosing over a total of 64 weeks. Based on safety and efficacy results through week 40, efeglenatide is planned to be submitted for approval within the year.
Kim Na-young, head of new product development (executive director) at Hanmi Pharmaceutical, said, "If a drug has fewer side effects, it improves dosing convenience and treatment persistence, which is advantageous for long-term management," and added, "In this respect, efeglenatide has few side effects and can simultaneously manage metabolic diseases in an integrated manner, so it is expected to provide a new treatment option not only for patients with obesity but also for patients at high risk of diabetes and metabolic disease."
Hanmi Pharmaceutical CEO Park Jae-hyun said, "With efeglenatide selected by the Ministery of Food and Drug Safety for fast-track review, securing the possibility of early approval, we have taken a step closer to commercialization as a 'national obesity drug,'" and added, "We will also push ahead without delay with our goal of filing within the year and accelerate the entire process so that you can meet Hanmi's obesity drug as early as the second half of next year."