Hanmi Pharmaceutical said on the 1st that it signed a licensing 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 to receive up to an additional $1.185 billion (about 1.7844 trillion won) upon achieving clinical development, regulatory approval and commercialization milestones, and, separately, royalties tied to sales after product launch.
Sonefpeglutide is a long-acting biologic drug candidate that mimics GLP-2, an endogenous hormone that aids intestinal mucosal growth and regeneration. Hanmi Pharmaceutical's proprietary platform technology "LAPSCOVERY" was applied, and it is currently being developed as a treatment for rare gastrointestinal diseases such as short bowel syndrome.
Hanmi Pharmaceutical has focused on the biological effects of GLP-2—promoting intestinal growth, alleviating inflammation, protecting the intestinal mucosa and regeneration—and has presented results proving 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 Hanmi Pharmaceutical completes the ongoing global phase 2 trial of sonefpeglutide for short bowel syndrome, Lilly plans to pursue additional clinical studies (phase 3) and development based on the preceding nonclinical and clinical data.
Im Joo-hyun, vice chair of Hanmi Group, said, "It is highly meaningful that Lilly, an innovative company drawing global attention, highly evaluated the development potential of sonefpeglutide," adding, "We will continue to put Hanmi's mission of 'respect for humanity and value creation' into practice through the development of innovative new drugs."
Meanwhile, Hanmi Pharmaceutical previously obtained U.S. Food and Drug Administration (FDA) approval for a biologic drug to which its proprietary platform technology LAPSCOVERY was applied, and said it is currently conducting global clinical trials on five candidate substances.