Hanmi Pharm has announced an accelerated timeline for the market launch of its glucagon-like peptide-1 (GLP-1) receptor agonist, efpeglenatide, for obesity treatment. Originally slated for the first half of 2027, the company now aims to release the drug in the second half of 2026. This strategic move is underpinned by ongoing phase 3 clinical trials in Korea and projections of annual sales exceeding 100 billion won ($71 million).
Differentiating Efpeglenatide
According to Hanmi Pharm, efpeglenatide distinguishes itself from other GLP-1 receptor agonists through its gradual release mechanism. This feature is designed to mitigate the gastrointestinal side effects commonly associated with this class of drugs. The company also emphasizes the potential cardiovascular and renal protective benefits of efpeglenatide, citing large-scale studies that have demonstrated its efficacy in reducing the risk of major cardiovascular and renal events.
Digital Combination Therapy
Hanmi is also developing a "digital combination drug" that integrates efpeglenatide with digital therapeutics. This platform aims to provide personalized obesity management solutions, including tailored diet plans, exercise regimens, and medication adherence support. The company plans to manufacture efpeglenatide at its Pyeongtaek Bioplant in Gyeonggi-do, ensuring a stable supply and competitive pricing compared to imported alternatives.
Hanmi Obesity Pipeline (H.O.P.) Project
Building on efpeglenatide’s expected success, Hanmi plans to introduce advanced obesity treatments as part of its Hanmi Obesity Pipeline (H.O.P.) project, launched in September 2023. This pipeline includes a next-generation triple-acting therapy (LA-GLP/GIP/GCG, code-named HM15275), which targets over 25 percent weight reduction while minimizing muscle loss and addressing metabolic conditions. HM15275 is currently in phase 1 trials in the U.S., with phase 2 trials expected to begin by late 2025.
The pipeline also features HM17321, a potential "first-in-class" obesity treatment that can increase muscle mass while reducing weight. Presented at the ObesityWeek conference in the U.S., HM17321 has demonstrated competitive advantages in both monotherapy and combination therapy. Phase 1 clinical trials for HM17321 are expected to begin in the second half of 2025. The H.O.P. project also includes oral small-molecule drugs, microneedle patches, and inhalable powder formulations designed to enhance convenience for patients.
