Eli Lilly has expanded its glucagon-like peptide (GLP) portfolio in an intriguing direction by licensing a phase 2-stage GLP-2 agonist from Hanmi Pharm.
The Korean biotech has already taken the drug, called sonefpeglutide, into a mid-stage study for short bowel syndrome (SBS). According to a Sunday night release, Hanmi will complete that trial while Lilly will launch fresh studies “based on [the drug’s] nonclinical and clinical data.”
In return for the license of sonefpeglutide in all countries except Korea, Lilly will pay $75 million upfront, with potentially up to a further $1.185 billion to follow in clinical, regulatory and commercialization milestones. Hanmi will also be in line for a slice of the royalties if the drug makes it to market.
The FDA approved a GLP-2 drug to treat SBS as far back as 2012 in the form of Takeda’s Gattex. While Gattex is administered as a daily injection, Hanmi has been pitching its long-acting GLP-2 analog as a way to reduce patients’ treatment burden by offering a monthly option.
With Zealand Pharma’ SBS approval application for its own GLP-2 drug glepaglutide knocked back by the FDA in 2024, Gattex remains ripe for a challenger.
SBS is a rare condition defined by the loss of more than 60% of the small intestine due to congenital or other causes. It affects around 24.5 out of every 100,000 newborns globally, according to Hanmi, and can also affect adults who had have surgeries to resolve inflammatory bowel disease, tumors or other issues.
The Korean biotech has previously pointed to preclinical studies that it said demonstrated how sonefpeglutide can promote intestinal growth, reduce inflammation and protect intestinal mucosa.
Sonefpeglutide was developed with Hanmi’s long-acting protein and peptide discovery platform, dubbed Lapscovery. The platform has already secured some success via the FDA approval in 2022 of the white blood cell booster Rolvedon, which Spectrum Pharmaceuticals licensed from Hanmi.
“It is highly meaningful that Lilly—one of the most closely watched innovators globally—has highly recognized the development potential for sonefpeglutide,” Hanmi’s Vice Chairman Juhyun Lim said in the May 31 release.
Lilly’s existing GLP-related portfolio stretches from the blockbuster Zepbound to next-gen weight loss drugs like the triple agonist retatrutide and the oral option orforglipron. However, the Big Pharma has been making some progress in gastrointestinal indications.
While Lilly hasn’t specifically explored SBS, the company is testing combinations of Zepbound’s ingredient tirzepatide with its approved IL-23 antagonist Omvoh in phase 3 trials for inflammatory bowel diseases like Crohn’s disease and ulcerative colitis. The pharma also has an oral α4β7 antagonist called zotemtegrast—which was acquired as part of the Morphic Therapeutic buyout—in phase 2 development for the same indications.
Adding Hanmi’s sonefpeglutide to Lilly’s pipeline comes amid a wide-ranging push by the pharma to spend its Zepbound billions bulking out its portfolio on various fronts. This year’s shopping spree has included buying a pair of in vivo CAR-T biotechs, along with a trio of vaccine companies and next-gen JAK inhibitor biotech Ajax Therapeutics, to name just a few.
For its part, Hanmi is in the process of buying Canada-based Aptose Biosciences for its acute myeloid leukemia treatment tuspetinib.
