Eli Lilly Secures $1.26 Billion Licensing Deal for Hanmi's GLP-2 Drug Sonefpeglutide
核心洞察
Eli Lilly has licensed sonefpeglutide, a once-monthly GLP-2 (搜索) analogue from Hanmi Pharma (搜索), for $75 million upfront plus up to $1.185 billion in milestone payments.
The drug is currently in Phase 2 trials for short bowel syndrome (搜索), a rare condition where patients cannot absorb sufficient nutrients from food.
Sonefpeglutide offers potential advantages over existing treatments with its monthly dosing schedule compared to Takeda (搜索)'s daily Gattex, the only approved GLP-2 (搜索) agonist.
Eli Lilly has secured worldwide licensing rights to sonefpeglutide, a novel GLP-2 (搜索) analogue developed by South Korean pharmaceutical company Hanmi Pharma (搜索), in a deal worth up to $1.26 billion. The agreement grants Lilly exclusive development, manufacturing, and commercialization rights for the drug across multiple gastrointestinal indications, excluding South Korea.
Deal Structure and Financial Terms
Under the licensing agreement, Lilly is paying $75 million upfront to Hanmi, with an additional $1.185 billion in potential milestone payments tied to clinical development, regulatory approval, and commercialization achievements. Hanmi will also receive separate royalties following product launch.
The deal represents a significant validation of Hanmi's drug development capabilities, particularly its LAPSCOVERY sustained-release platform technology. In the first quarter of this year, Hanmi invested 65.2 billion won, representing 16.6% of its revenue, in research and development activities.
Sonefpeglutide's Therapeutic Profile
Sonefpeglutide (HM15912) is a long-acting GLP-2 (搜索) analogue designed for once-monthly subcutaneous injection. The drug leverages GLP-2's natural biological functions, which include promoting intestinal growth, protecting and regenerating cells lining the gastrointestinal tract, and reducing inflammation.
Hanmi is currently conducting the DOLPHINS-2 Phase 2 trial in the United States, testing sonefpeglutide in patients with short bowel syndrome (搜索) who have stomas and intestinal failure (搜索). Results from this study are expected next year. Short bowel syndrome is a rare condition where patients cannot absorb sufficient nutrients from food due to an inadequately long small intestine or impaired intestinal function.
The condition can result from surgical procedures, intestinal damage from cancer treatment, or conditions affecting gastrointestinal motility. Some children are born with abnormally short small intestines.
Competitive Landscape
The GLP-2 (搜索) agonist market currently features Takeda (搜索)'s Gattex (teduglutide), the only approved treatment for short bowel syndrome (搜索) in the United States. Approved by the FDA in 2012, Gattex requires once-daily oral administration and generated approximately $870 million in global sales last year.
Several competitors are developing alternative GLP-2 (搜索) therapies with different dosing schedules. Ironwood Pharma (搜索) is advancing apraglutide, a weekly GLP-2 drug that has faced delays due to FDA requirements for a second Phase 3 trial. Zealand Pharma has glepaglutide in Phase 3 development with twice-weekly dosing. 9 Meters Biopharma (搜索) was developing vurolenatide but filed for bankruptcy in 2023.
Development Strategy
Hanmi will complete the ongoing Phase 2 trial for short bowel syndrome (搜索), while Lilly plans to explore additional clinical trials for sonefpeglutide based on existing preclinical and clinical data. According to Hanmi, GLP-2 (搜索) has potential applications across various intestinal diseases beyond short bowel syndrome.
Hanmi Group Vice Chairman Lim Joo-hyun stated, "This agreement recognizes the development potential of Sonefpeglutide. We will continue to pursue our mission of 'respecting humanity and creating value' through innovative drug development."
Previous Collaboration History
This marks the second major licensing agreement between Lilly and Hanmi. In 2015, the companies established a $690 million alliance to develop a BTK (搜索) inhibitor for rheumatoid arthritis (搜索). That program reached Phase 2 development but was subsequently abandoned due to disappointing trial results.
Hanmi is currently advancing over 30 pipeline projects, including the GLP-1 (搜索) obesity (搜索) drug Epeglanatide (搜索), which the company aims to commercialize within the year. The company is conducting global clinical trials for five other candidates utilizing the same LAPSCOVERY platform technology employed in sonefpeglutide's development.