Eli Lilly Signs Up to $1.2B Licensing Deal for Hanmi GLP-2 Therapy in Short Bowel Syndrome

Eli Lilly has entered into a licensing agreement with Hanmi Pharmaceutical for sonefpeglutide, a long-acting glucagon-like peptide-2 (GLP-2) receptor agonist in Phase 2 development for short bowel syndrome (SBS), a rare gastrointestinal disorder characterized by inadequate intestinal absorption.

Under the terms of the agreement, Lilly will obtain exclusive worldwide rights to develop, manufacture, and commercialize sonefpeglutide outside of South Korea. Hanmi retains rights to the asset in its domestic market and will continue to conduct clinical development activities, including an ongoing Phase 2 trial in SBS patients.¹

The deal includes a $75 million upfront payment, with total potential value of up to approximately $1.2 billion if clinical, regulatory, and commercial milestones are achieved. Hanmi is also eligible to receive tiered royalties on net sales if the product reaches the market.¹

Short bowel syndrome and GLP-2 mechanism

Short bowel syndrome occurs when a significant portion of the small intestine is absent or nonfunctional, often following surgical resection for conditions such as Crohn’s disease, ischemia, or trauma. Patients may require long-term parenteral nutrition due to impaired nutrient absorption.

GLP-2 receptor agonists are designed to promote intestinal adaptation by increasing mucosal growth, enhancing nutrient absorption, and improving gut function. The mechanism has been validated in clinical practice through currently approved therapies such as teduglutide, which is administered daily and is used to reduce dependence on parenteral nutrition.

Sonefpeglutide is a long-acting GLP-2 analog designed to extend peptide half-life and reduce dosing frequency compared with existing GLP-2 therapies. According to previously published company materials, the candidate is being evaluated for less frequent administration schedules in clinical studies.²

Clinical development status

Hanmi is conducting a phase 2 clinical trial evaluating sonefpeglutide in patients with short bowel syndrome. The study is assessing efficacy and safety endpoints relevant to intestinal absorption and nutritional support requirements.

According to Hanmi, the Phase 2 program is assessing safety, tolerability, and efficacy endpoints relevant to intestinal absorption and nutritional support requirements in SBS patients. Lilly plans to use existing nonclinical and clinical data generated by Hanmi to inform further development activities under the agreement.³

Lilly will use existing nonclinical and clinical data generated by Hanmi to support further development planning. The agreement includes collaboration between the companies on ongoing and future studies, with Lilly taking responsibility for global development activities outside Korea.

Therapeutic landscape

Treatment options for short bowel syndrome remain limited. Standard care includes parenteral nutrition and symptom management, while pharmacologic options are restricted primarily to GLP-2 receptor agonists.

Teduglutide (Gattex), a recombinant GLP-2 analog, is currently approved in multiple regions for SBS and has been shown to reduce the need for parenteral nutrition in some patients. However, treatment requires daily injections and ongoing monitoring for adverse effects.

Long-acting GLP-2 analogs in development, including sonefpeglutide, are being studied to assess whether extended dosing intervals can maintain clinical benefit while reducing treatment burden.

Context of the agreement

The licensing agreement follows a series of collaborations between large pharmaceutical companies and smaller biopharmaceutical developers involving peptide-based gastrointestinal therapies. These arrangements typically include upfront payments, milestone-based compensation, and royalties contingent on regulatory approval and commercial performance.

Sonefpeglutide is part of Hanmi’s LAPSCOVERY platform, which is designed to extend the half-life of peptide and protein therapeutics through molecular modification technologies. The platform has been applied to multiple investigational compounds across metabolic and endocrine indications.

References

1. Fierce Biotech – Lilly signs up to $1.2B deal for Hanmi GLP-2 drug in short bowel syndrome
   https://www.fiercebiotech.com/biotech/lilly-pens-12b-deal-hanmis-glp-2-drug-being-aimed-short-bowel-syndrome
2. Hanmi Pharmaceutical – Press release: Sonefpeglutide licensing and development update
   https://www.hanmipharm.com/about/investor-relations/press/detail-4324.hm
3. PR Newswire – Hanmi Pharmaceutical announces licensing agreement with Eli Lilly for GLP-2 analog
   https://www.prnewswire.com/news-releases/hanmi-signs-licensing-deal-with-lilly-for-sonefpeglutide-lapsglp-2-analog-302786656.html