Hanmi Pharmaceutical has licensed out sonepegglutide, a glucagon-like peptide (GLP)-2 class drug candidate being developed as a treatment for intestinal disease, to U.S.-based Eli Lilly. As sonepegglutide was developed based on Hanmi's long-acting platform technology LAPSCOVERY, technology transfers of follow-up pipelines applying LAPSCOVERY are expected to gain momentum.
Hanmi Pharmaceutical announced Wednesday that it has signed a license agreement with Lilly for the development, manufacturing, and commercialization of sonepegglutide. Under the agreement, Hanmi will receive a confirmed upfront payment of $75 million (approximately 112.9 billion won) and may receive up to an additional $1.185 billion (1.7844 trillion won) based on clinical development, regulatory approval, and commercialization milestones. The total deal size reaches up to $1.26 billion (approximately 1.9 trillion won), the second-largest technology export contract in Hanmi Pharmaceutical's history.
Sonepegglutide is a GLP-2 class candidate being developed to treat short bowel syndrome. Short bowel syndrome is a rare disease in which more than 60% of the small intestine is resected, preventing proper absorption of nutrients. The only currently approved treatment is Takeda Pharmaceutical's Gattex, which records global annual sales of 1 trillion won. Sonepegglutide is being developed with the goal of reducing the daily dosing required by Gattex to once a month, and is currently undergoing global Phase 2 clinical trials.
LAPSCOVERY, Hanmi Pharmaceutical's long-acting platform technology, is cited as the basis for this competitiveness. LAPSCOVERY, developed in-house by Hanmi, extends the duration of biopharmaceuticals in the body, reducing dosing frequency. Lee Myung-sun, a researcher at DB Financial Investment, said, "Since sonepegglutide has significantly extended its dosing cycle through LAPSCOVERY, it will be able to secure competitiveness in terms of patient convenience."
In addition to sonepegglutide, LAPSCOVERY is being applied to Hanmi's major new drug pipelines including efocipegtrutide (obesity and metabolic disease), efinopegdutide (obesity and metabolic disease), efegerglucagon (congenital hyperinsulinism), and HM16390 (oncology).
Some of the candidates applying LAPSCOVERY have already led to commercialization and technology exports. Rolontis, a neutropenia treatment developed by Hanmi, received approval from the U.S. Food and Drug Administration (FDA), and efinopegdutide was licensed out to Merck (MSD) in the U.S. in 2020. With this latest contract reaffirming the business viability of the LAPSCOVERY platform, attention is also turning to the possibility of technology transfers for follow-up pipelines.
The industry is also paying attention to the fact that Lilly, which leads the GLP-1 class obesity treatment market, has moved to secure a GLP-2 asset. Since GLP-1 class treatments accompany gastrointestinal adverse reactions such as vomiting, diarrhea, and constipation, there is a strong possibility of reducing the burden of side effects through future combination with GLP-2. While GLP-1 induces weight loss by suppressing appetite and regulating blood sugar, GLP-2 promotes intestinal growth and is responsible for protecting and regenerating the intestinal mucosa.
Hanmi Pharmaceutical also believes that Lilly is focused on the expandability of GLP-2 rather than simply securing a short bowel syndrome treatment. A Hanmi Pharmaceutical official explained, "After completing the global Phase 2 clinical trials for short bowel syndrome currently underway, Lilly will lead subsequent development, and the scope of the contract also includes multiple indications rather than the single short bowel syndrome indication."
This contract is also drawing attention to the possibility of additional cooperation, as it marks Lilly's first collaboration with Hanmi in seven years since returning the rights to a candidate previously licensed from Hanmi. In 2015, Lilly licensed in HM71224, a BTK inhibitor being developed as an autoimmune disease treatment, from Hanmi, but returned the rights in 2019 after failing to demonstrate efficacy in Phase 2 clinical trials for rheumatoid arthritis.
The industry assesses that this case differs from past technology return cases, as sonepegglutide was contracted at a stage where global Phase 2 clinical trials had progressed substantially. Lee said, "Generally, the size of the upfront payment is highly correlated with the development stage," adding, "Given the size of the upfront payment, there is room to view this as Lilly having signed the contract after reviewing the Phase 2 data."
However, late-stage clinical assets are not entirely free from the risk of rights returns. In fact, Hanmi licensed out efpeglenatide, a GLP-1 class diabetes treatment, to French pharmaceutical company Sanofi in 2015 in a deal worth 3.9 billion euros (approximately 6.8354 trillion won). Efpeglenatide subsequently progressed through global Phase 3 clinical trials, but Sanofi ultimately returned the rights as it restructured its R&D strategy in 2020. An industry official emphasized, "At the time, Sanofi stated that it was a business strategy decision rather than an issue with the efficacy or safety of efpeglenatide," adding, "Beyond clinical performance, deals can also be affected by changes in the business strategies of global pharmaceutical companies."
