Hanmi Pharmaceutical said on the 1st that it signed a license agreement with U.S. global drugmaker Eli Lilly and Company for the development, manufacturing and commercialization of the biologic drug candidate "Sonefpeglutide (HM15912)."
The deal is worth up to $1.26 billion (about 1.8973 trillion won). Hanmi Pharmaceutical will receive a nonrefundable upfront payment of $75 million (about 112.9 billion won). It will also be eligible for up to an additional $1.185 billion (about 1.7844 trillion won) in clinical development, regulatory approval and commercialization milestones, and, separately, royalties tied to sales after product launch.
Sonefpeglutide is a glucagon-like peptide (GLP)-2 analog drug candidate that uses Hanmi Pharmaceutical's long-acting biologics platform technology "LAPSCOVERY." GLP-2 is a hormone that promotes intestinal growth, alleviates inflammation, and protects and regenerates the intestinal mucosa, and it is being developed as a treatment for rare gastrointestinal diseases such as short bowel syndrome.
Focusing on the biological effects of GLP-2—intestinal growth promotion, inflammation alleviation, intestinal mucosal protection and regeneration—Hanmi Pharmaceutical has presented results validating these through various preclinical studies at major conferences.
Under the agreement, Lilly secured exclusive rights to develop, manufacture and commercialize Sonefpeglutide worldwide except in Korea.
Once the global phase 2 trial of Sonefpeglutide for short bowel syndrome that Hanmi Pharmaceutical is conducting is completed, Lilly plans to pursue further clinical development based on the preclinical and clinical data obtained.
Lim Joo-hyun, vice chairman of Hanmi Group, said, "It is significant that Lilly, an innovation company drawing global attention, highly evaluated the development potential of Sonefpeglutide," and added, "We will continue to put Hanmi's mission of 'respect for humanity and value creation' into practice through innovative drug development."
Separately, Hanmi Pharmaceutical said it previously obtained U.S. Food and Drug Administration (FDA) approval for a biologic drug developed with its proprietary LAPSCOVERY platform technology and is currently conducting global clinical trials on five candidates.