Hanmi Pharmaceutical said on the 17th that it has applied to the Ministery of Food and Drug Safety for domestic approval of Efpeglenatide, a glucagon-like peptide (GLP)-1 drug developed as a Korea-tailored obesity treatment.
Earlier, Efpeglenatide was designated last month by the Ministery of Food and Drug Safety as a target product under the Global Innovation product Fast-track (GIFT) support system. Accordingly, the review is expected to proceed on a timeline about 25% shorter than a standard review.
Efpeglenatide is a GLP-1 class obesity drug candidate developed in-house by Hanmi Pharmaceutical. In a phase 3 trial of 448 adult patients with obesity without diabetes, it showed up to a 30% reduction in body weight at week 40 of dosing.
At week 40, the average weight reduction rate in the Efpeglenatide group was 9.75%, showing a significant difference compared with the placebo group. In particular, among female patients with a BMI under 30 kg/㎡, an average weight reduction of 12.20% was observed, and the maximum weight reduction rate reached 30.14%. Gastrointestinal adverse events were reported to be lower or mild compared with existing GLP-1 obesity treatments.
Hanmi Pharmaceutical views obesity as a complex metabolic disease that leads to type 2 diabetes and cardiovascular disease, and is pushing to expand the indications for Efpeglenatide. It is currently conducting a phase 3 combination trial with an existing diabetes drug, an SGLT-2 inhibitor, and the blood sugar control drug metformin, and is targeting approval for a diabetes indication in 2028.
Efpeglenatide has been developed in an auto-injector formulation for self-injection. The company plans to expand the value of this obesity drug by pursuing ▲expansion to a diabetes indication ▲formulation development such as prefilled syringe (PFS) and multi-pen ▲development of Korea's first digital convergence medicine (DTx) by a domestic drugmaker ▲building customized health functional food and OTC packages.
In particular, the digital convergence medicine will be developed to integrate a drug with a digital medical device to manage weight-loss support, improved muscle strength and exercise performance, and lifestyle changes together. The goal is to file an investigational new drug (IND) application in the first quarter of 2026.
Kim Nayoung, executive director and head of new product development at Hanmi Pharmaceutical, said, "We are making companywide efforts to win approval for Efpeglenatide with a goal of launching next year," adding, "This application is another beginning."
Chief Executive Park Jaehyun said, "Through the launch of Efpeglenatide, we will present a new direction for treating obesity and metabolic diseases beyond simple weight loss and build a treatment paradigm that substantially improves patients' quality of life."