Hanmi Pharmaceutical Advances World’s First Obesity Drug Targeting Muscle Growth into Clinical Development 

Hanmi unveils translational data for HM17321 at ISMB/ECCB 2025 in Liverpool
Expected benefits include fat loss, muscle gain, and improved muscle function in humans 

Senior Researcher Dr. Seunghwan Jung from Hanmi R&D Center presented key insights on the novel obesity treatment candidate HM17321 to attendees at the ISMB/ECCB 2025 conference held in Liverpool, UK, on July 22 (local time).

(August 05, 2025) Hanmi Pharmaceutical has taken a critical step forward in advancing HM17321 (LA-UCN2), a first-in-class obesity therapy, into global Phase 1 clinical trials. Unlike conventional approaches that primarily focus on weight loss, this investigational drug represents a novel advancement in the field of metabolic disease. The company recently unveiled promising translational research results that validate the drug’s clinical potential.

At the ^[1]ISMB/ECCB 2025 conference, held July 20-24 in Liverpool, UK, Hanmi presented a scientific poster session showcasing preclinical study results that demonstrated HM17321’s potential to improve obesity outcomes by enhancing metabolic health, including increased muscle mass, improved muscle function, and fat reduction. 

During the presentation, Hanmi revealed a machine learning based proteome-to-phenome (P2P) analysis integrating proteomic data from animal models with human phenomic databases. This cross-species translation approach predicted that the therapeutic benefits observed in animal studies with HM17321 may also manifest in humans, a major hurdle in obesity drug development.

HM17321 is a long-acting selective CRF2 receptor agonist designed using Hanmi’s proprietary AI-driven structural modeling platform. Unlike conventional incretin-based therapies such as GLP-1 receptor agonists, HM17321 uniquely targets the corticotropin-releasing factor receptor 2 (CRF2R), representing a novel mechanism of action in obesity management.

More than simply preserving muscle mass, HM17321 has shown potential to actively increase lean mass while selectively reducing fat. This represents a paradigm shift in the therapeutic landscape and positions HM17321 as a true first-in-class candidate innovation.

In the study, proteomic profiles from HM17321-treated diet-induced obese (DIO) mice were compared with those of human blood proteomics associated with various diseases and physical characteristics. Notably, HM17321 induced circulating proteins linked to increased fat-free mass and grip strength, indicating a predicted enhancement on skeletal muscle mass and function in human. 

These results not only reinforce the drug’s preclinical efficacy but also suggest the potential to translate these effects clinically. Moreover, this approach enables broader exploration of additional therapeutic benefits, potential indications, and safety-related signals that are difficult to identify through animal studies alone. As such, it is expected to contribute to the refinement of future non-clinical and clinical development strategies, while enhancing overall R&D efficiency. 

“The transition from preclinical to clinical development is one of the most uncertain phases in drug discovery,” said Dr. Haemin Chon, Head of Clinical Translational Research Team at Hanmi R&D Center. “These findings offer a meaningful approach to mitigate that uncertainty and could significantly enhance the efficiency of Hanmi’s drug development efforts.”

Hanmi’s Clinical Translational Research Team is actively leveraging multi-omics data, including genomics, transcriptomics, and proteomics, from both animal and human sources. By integrating cutting-edge bioinformatics and machine learning, the team aims to predict clinical responses and potential side effects of new drug candidates in advance.

“The data strongly supports the clinical advancement of HM17321, with robust scientific evidence suggesting the replication of its pharmacological effects in humans,” said Dr. In Young Choi, Head of R&D at Hanmi Pharmaceutical. “We’re proud to pioneer a new standard in obesity care―one that goes beyond weight loss to deliver holistic improvements in metabolic health and muscle performance.”

Hanmi plans to initiate Phase 1 clinical trials for HM17321 in Q4 2025, with the goal of establishing a new global benchmark in obesity treatment through qualitative, rather than purely quantitative, weight loss.

■ Contact info:

    Official Websites: www.hanmipharm.com

    innovation@hanmi.co.kr, +82-410-0467

[1] The ISMB/ECCB conference, one of the world’s most prestigious events in the field of bioinformatics, is an international forum where the latest advancements in biology driven by cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), and big data are shared. This year’s event marked the joint hosting of the 33rd Intelligent Systems for Molecular Biology (ISMB) conference and the 24th European Conference on Computational Biology (ECCB).