Eli Lilly has entered a licensing agreement with South Korea’s Hanmi Pharm for sonefpeglutide, a Phase 2 glucagon-like peptide-2 (GLP-2) agonist being studied as a treatment for short bowel syndrome (SBS).
Under the agreement, Lilly will obtain exclusive rights to manufacture and sell sonefpeglutide in all countries except South Korea. Hanmi will complete the ongoing mid-stage clinical study in SBS, while Lilly plans to conduct additional clinical trials based on the drug’s existing nonclinical and clinical data.
The deal includes an upfront payment of $75 million from Lilly. Hanmi could receive up to an additional $1.185 billion in clinical, regulatory, and commercialization milestone payments. The company will also be eligible for royalties if the drug reaches the market.
Sonefpeglutide is a long-acting GLP-2 analog being developed for short bowel syndrome, a rare condition characterized by the loss of more than 60% of the small intestine due to congenital or other causes. The condition affects newborns as well as adults who have undergone surgery related to inflammatory bowel disease, tumors, or other medical issues. According to Hanmi, SBS affects approximately 24.5 out of every 100,000 newborns globally.
Hanmi has previously pointed to preclinical studies that it said showed sonefpeglutide can promote intestinal growth, reduce inflammation and protect intestinal mucosa. The company has also presented the drug as a potential monthly treatment option. Existing SBS treatment Gattex, developed by Takeda and approved by the U.S. Food and Drug Administration in 2012, is administered as a daily injection.
The SBS market has seen limited competition. Zealand Pharma sought approval for its GLP-2 candidate glepaglutide, but the FDA rejected the application in 2024. As a result, Gattex remains the only approved GLP-2 therapy for the condition mentioned in the provided information.
Sonefpeglutide was developed using Hanmi’s long-acting protein and peptide discovery platform, Lapscovery. The platform was also used in the development of Rolvedon, a white blood cell booster licensed to Spectrum Pharmaceuticals and approved by the FDA in 2022. Hanmi has stated that five other clinical programs are also based on the technology.
“It is highly meaningful that Lilly—one of the most closely watched innovators globally—has recognized the development potential for sonefpeglutide,” Hanmi Vice Chairman Juhyun Lim said in a statement.
The licensing agreement adds a short bowel syndrome candidate to Lilly’s pipeline. The company’s GLP-related portfolio includes Zepbound, Mounjaro, oral Foundayo and the investigational triple agonist retatrutide. In gastrointestinal diseases, Lilly is conducting Phase 3 studies combining tirzepatide with its approved IL-23 antagonist Omvoh in inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. The company is also developing the oral α4β7 antagonist zotemtegrast, acquired through the Morphic Therapeutic buyout, in Phase 2 studies for the same indications.
The Hanmi agreement comes during a period of dealmaking by Lilly that has included acquisitions of two in vivo CAR-T biotechnology companies, three vaccine companies, and Ajax Therapeutics. Separately, Hanmi is pursuing the acquisition of Canada-based Aptose Biosciences and its acute myeloid leukemia treatment candidate tuspetinib.
Hanmi has reached a landmark licensing agreement with Eli Lilly for its Phase 2 GLP-2 drug candidate designed to treat short bowel syndrome (SBS). The deal, valued at up to $1.26 billion in potential payments, represents a significant milestone for Hanmi and underscores growing industry interest in therapies addressing rare gastrointestinal disorders.
Hanmi Advances Innovation in Short Bowel Syndrome
The licensed therapy developed by Hanmi is based on GLP-2 technology, which aims to improve intestinal function and nutrient absorption in patients affected by short bowel syndrome. Through this partnership.
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