Hanmi Pharm's Innovative Obesity Drug for "Muscle Gain" Receives FDA Phase 1 Approval

A 'First-in-Class' Drug That Increases Muscle While Reducing Weight

Hanmi Pharm has officially begun Phase 1 clinical trials for a "next-generation innovative obesity drug" that is the world's first to simultaneously achieve weight loss and muscle gain.

Seoul Songpa-gu Hanmi Pharm headquarters building. Hanmi Pharm

On November 4 (local time in the United States), Hanmi Pharm announced on November 6 that it had received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate Phase 1 clinical trials of its "next-generation obesity treatment (LA-UCN2, code name: HM17321)." This clinical trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321 in healthy adults and obese patients.

HM17321 is being developed as a "first-in-class" innovative obesity drug that not only compensates for muscle loss but also achieves what was previously thought impossible: simultaneous "muscle mass increase" and "selective fat reduction."

HM17321 is a UCN2 analog that selectively targets the CRF2 receptor, rather than incretin receptors such as GLP-1 (glucagon-like peptide-1). It was designed using advanced artificial intelligence and structural modeling technologies developed at Hanmi Pharm's R&D Center.

The CRF family consists of signaling molecules related to stress response and recovery. According to Hanmi Pharm, selectively targeting the CRF2 receptor among these can directly induce fat reduction, muscle gain, and improved muscle function.

HM17321 not only presents a new paradigm for obesity treatment as a monotherapy, but also demonstrates both quantitatively and qualitatively superior weight loss efficacy when used in combination with existing incretin-based obesity treatments, thereby expanding its potential for innovation.

Most antibody-based muscle-preserving drugs are inconvenient for obese patients due to the need for intravenous administration. In addition, when combined with existing obesity treatments administered subcutaneously, differences in administration methods present limitations. Furthermore, significant side effects and the inability to improve muscle function beyond merely preserving muscle mass are also cited as drawbacks.

In contrast, HM17321 is designed as a "peptide-based compound," offering greater ease of administration and cost competitiveness. In particular, if developed as a combination therapy, it can be administered together with existing incretin-based drugs, which are also peptides, significantly improving patient convenience.

Choi Inyoung, Head of the R&D Center, stated, "HM17321 is not simply a weight loss drug; it is fundamentally differentiated from existing treatments in that it aims for integrated efficacy-fat reduction, muscle gain, and improvement in exercise and metabolic function-all at once." He added, "Hanmi Pharm views obesity not as a numbers game on the scale, but as a fundamental metabolic disease, and we are committed to opening a new horizon in obesity treatment by providing 'patient-centered, personalized solutions.'"

Meanwhile, Hanmi Pharm's obesity drug project, "H.O.P (Hanmi Obesity Pipeline)," consists of a total of six pipelines and is being systematically pursued through multi-layered mechanisms and differentiated strategies. Recently, Hanmi Pharm announced the topline interim results of the Phase 3 trial for "Efeglenatide," the first product expected to be launched from H.O.P, signaling its ambition to become a "national obesity drug" based on its excellent efficacy and established safety profile.