Lilly licenses Hanmi GLP-2 drug in $1.26bn deal

Eli Lilly's relentless pipeline-building drive has continued with a licensing agreement for sonefpeglutide, a GLP-2 analogue developed by Hanmi Pharma, across multiple gastrointestinal indications.

Lilly is paying $75 million upfront for rights to sonefpeglutide (also known as HM15912) outside Hanmi's home market of Korea, with another $1.185 billion in clinical development, regulatory, and commercial milestone payments.

The partners haven't specified the indications covered by the license, but Hanmi has already started a US phase 2 trial (DOLPHINS-2) of the GLP-2 agonist in short bowel syndrome, a rare condition in which patients are unable to absorb enough nutrients from the foods they eat, either because their small intestine isn't long enough or is not working properly.

It can be caused by surgery, damage to the intestines – for example, caused by cancer treatment – or conditions that lead to poor motility in the gastrointestinal tract. Some children, however, are born with an abnormally short small intestine.

GLP-2's functions in the body include promoting intestinal growth, as well as the protection and regeneration of the cells lining the GI tract, and it also seems to dampen down inflammation. According to Hanmi, it has potential in various intestinal diseases.

Sonefpeglutide is a long-acting analogue, designed to be delivered once-monthly by subcutaneous injection, and developed using Hanmi's LAPSCOVERY platform. In DOLPHINS-2, it is being tested in patients with stomas who have SBS and intestinal failure, with results due next year.

Hanmi will continue to conduct the ongoing phase 2 trial in SBS through completion, while Lilly will "explore additional clinical trials for sonefpeglutide based on its non-clinical and clinical data," said the two partners.

There is already one GLP-2 agonist on the US market, Takeda's once-daily, oral Gattex (teduglutide), which was approved for SBS by the FDA in 2012 and made around $870 million in sales globally last year.

Ironwood Pharma is working on a weekly GLP-2 drug, apraglutide, which has been delayed by an FDA request for a second phase 3 trial, while Zealand Pharma has twice-weekly glepaglutide in phase 3 and 9 Meters Biopharma was working on its vurolenatide candidate but filed for bankruptcy in 2023.

This is not the first time that Lilly has turned to Hanmi for a licensing opportunity. In 2015, the two companies forged a $690 million alliance to develop a BTK inhibitor for rheumatoid arthritis, which reached phase 2 development, but was abandoned on disappointing trial results.

The new deal comes amid a series of acquisitions and licensing deals signed by Lilly in 2026, including three vaccine company takeovers announced last week, that is being fuelled by rocketing sales of its GLP-1-acting weight-loss and obesity therapies.