#South Korea #Seoul #Genentech #Hanmi Pharm #HM17321

Hanmi Pharm Partners with Genentech for Innovative Obesity Treatment

In an exciting development in the pharmaceutical landscape, Hanmi Pharm has signed an exclusive licensing agreement with Genentech, a prominent member of the Roche Group. This collaboration will focus on the advancement and commercialization of Hanmi's cutting-edge treatment candidate, HM17321 (UCN2), which targets chronic weight management and related conditions, including obesity, type 2 diabetes, and cardiovascular diseases. Notably, this licensing agreement does not include South Korea, emphasizing the global ambition of this partnership.

Significant Financial Implications

The deal represents a substantial financial commitment from Genentech, valued at up to $2.3 billion. This figure encompasses an upfront payment of $190 million, milestone payments associated with development and regulatory achievements, and tiered royalties based on net product sales following commercialization. Such a robust financial framework underscores both companies' confidence in HM17321's potential to make significant inroads in the market for obesity treatments.

Unique Mechanism of Action

HM17321 is a proprietary analog of urocortin-2 (UCN2) and boasts a unique non-incretin mechanism of action. Unlike existing treatments based on GLP-1 (Glucagon-Like Peptide-1), which are effective in weight reduction but also lead to a decrease in lean body mass, HM17321 aims to promote weight loss while preserving lean body mass. This characteristic could represent a significant advancement in obesity treatment, addressing a critical need for a more balanced approach to weight management.

Preclinical studies have demonstrated promising outcomes, with HM17321 showing both qualitative and quantitative improvements in weight reduction. Its efficacy as a standalone treatment is noteworthy, as is its potential for use in combination with GLP-1 based therapies. Moreover, given its peptide-based nature, HM17321 may lay the groundwork for future fixed-dose combination (FDC) products, offering new options to patients struggling with obesity.

Clinical Development Journey

Hanmi Pharm is currently advancing HM17321 through its development phases. In November 2025, the U.S. FDA granted Investigational New Drug (IND) clearance, allowing Hanmi to initiate a Phase 1 clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM17321. This first phase is crucial as it involves healthy volunteers and individuals with obesity, paving the way for more extensive clinical testing.

Once Hanmi completes the Phase 1 trial, Genentech will take the baton, leading the next phase of clinical trials. This transition illustrates a strategic collaboration that brings together Hanmi's innovative research and Genentech's extensive clinical and commercialization expertise, promising a strong pathway toward bringing HM17321 to market.

A Vision for Healthier Outcomes

In-Young Choi, Senior Executive Vice President and Head of the RD Division at Hanmi Pharm, expressed enthusiasm for this partnership, stating, "The paradigm of obesity treatment is evolving beyond simple weight reduction toward improving body composition and restoring metabolic health." This vision reflects a fundamental shift in how obesity and related conditions are approached, focusing on comprehensive patient health rather than isolated weight loss.

Boris L. Zaïtra, head of Roche Corporate Business Development, commented on the significance of this collaboration, highlighting the necessity of a differentiated therapeutic strategy that not only targets fat mass reduction but also enhances muscle mass and function. This holistic approach is set to address unmet needs in the lives of individuals living with obesity and related metabolic disorders.

Conclusion

The licensing agreement between Hanmi Pharm and Genentech marks a pivotal moment in the pursuit of innovative therapies for obesity management. As the partnership evolves through clinical trials and future commercialization efforts, the期待 for HM17321 to transform the landscape of metabolic treatment grows stronger. With significant financial backing and a unique approach to obesity care, this collaboration could lead to meaningful changes in the way obesity and its related health challenges are understood and treated in the years to come.