Roche, through its subsidiary Genentech, has entered into a licensing agreement with South Korea-based Hanmi Pharm for HM17321, an investigational obesity therapy designed to support weight loss while preserving lean body mass. Under the agreement, Genentech will pay Hanmi $190 million upfront and could provide up to $2.3 billion in development, regulatory, and commercial milestone payments. Hanmi is also eligible to receive tiered royalties on future sales.
The agreement gives Genentech global rights to HM17321, excluding South Korea. Hanmi will complete the ongoing phase 1 clinical trial before Genentech assumes responsibility for phase 2 development and subsequent stages.
HM17321 is a non-incretin peptide therapy that mimics urocortin-2 (UCN2) and targets the CRF2 receptor. UCN2 is a signaling protein that has been found at elevated levels in people with chronic heart failure. The mechanism was previously explored by Eli Lilly in a heart failure program that was discontinued in 2019.
Candidate Designed to Address Weight Loss and Lean Body Mass
Researchers have studied UCN2 for decades and have reported its potential to reduce muscle atrophy. Hanmi has stated that HM17321 is designed to reduce fat mass while increasing lean mass.
According to the companies, existing GLP-1-based therapies have demonstrated substantial weight loss but are associated with reductions in lean body mass. HM17321 uses a non-incretin mechanism of action and is being developed with the goal of promoting weight loss while preserving lean body mass.
Hanmi stated that preclinical studies linked HM17321 to reductions in body weight and fat mass as both a standalone treatment and in combination with GLP-1-based therapies. The company has since advanced the candidate into a phase 1 study involving healthy volunteers and individuals with obesity. The trial is intended to assess the safety and tolerability of the therapy.
Companies Outline Development Plans for the Therapy
Roche plans to investigate HM17321 not only for obesity but also for related conditions, including type 2 diabetes and cardiovascular disease.
In discussing the agreement, In-Young Choi, head of Hanmi’s research and development division, said, “The paradigm of obesity treatment is evolving beyond simple weight reduction toward improving body composition and restoring metabolic health.”
Choi also said that the scientific mechanism and development potential of HM17321 had been recognized by the global market.
Boris Zaïtra, Head of Roche Corporate Business Development, said the companies intend to pursue an approach focused on reducing fat mass while improving muscle mass and muscle function. He also said the agreement adds a therapy with first-in-class potential to Roche’s cardiometabolic pipeline.
HM17321 Joins Other Obesity Programs Under Development
Roche has stated that it aims to become one of the top three companies operating in the weight-loss sector. Among its obesity programs is enicepatide, a dual GLP-1/GIP receptor candidate that the company aims to bring to market by 2030.
The company is also studying the oral GLP-1 candidate CT-996 in phase 2 trials. In addition, Roche is partnered with Zealand Pharma on petrelintide, a long-acting amylin analog.
Another obesity-related program is emugrobart, an anti-latent myostatin-sweeping antibody designed to increase muscle mass. The candidate is being evaluated in a phase 2 study in combination with Eli Lilly’s Mounjaro.
For Hanmi, the agreement follows other transactions completed this year, including the acquisition of Canadian cancer biotech Aptose Biosciences and a licensing agreement with Lilly covering a phase 2 GLP-2 agonist being developed as a potential treatment for short bowel syndrome.
Hanmi’s HM17321 obesity candidate has attracted major attention after Roche agreed to license global rights to the experimental treatment in a deal that could be worth up to $2.3 billion. The agreement gives Roche access to a promising metabolic disease program while providing Hanmi’s pipeline with a major international development partner.
Hanmi’s HM17321 Joins Roche’s Obesity Pipeline
The Hanmi’s candidate is an investigational long-acting treatment being developed for obesity and related metabolic conditions. Roche plans to advance the program as part of its broader strategy to build a next-generation obesity portfolio.
The deal gives Hanmi’s program access to Roche’s global development capabilities and resources.
Hanmi’s Next Steps in Clinical Development
The next stage will involve continued clinical evaluation of HM17321 to determine its safety, tolerability, effectiveness, and potential advantages compared with existing obesity treatments.
For Hanmi’s, positive clinical data will be essential to unlocking additional milestone payments and moving the candidate closer to potential regulatory submissions.
Hanmi’sOutlook in Obesity Treatment
The Roche transaction represents an important development for Hanmi’s obesity portfolio. If HM17321 demonstrates meaningful benefits in clinical trials, the candidate could become a significant addition to the rapidly evolving obesity-treatment landscape.
The partnership also highlights the increasing value pharmaceutical companies are placing on innovative metabolic disease programs.
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