Lilly licenses Hanmi's sonefpeglutide (LAPSGLP-2 analog) for multiple indications

Hanmi Pharm. Co., Ltd. ("Hanmi") announced that they have entered into a license agreement for the development, manufacturing and commercialization of Hanmi's biologic drug candidate sonefpeglutide (^LAPSGLP-2 analog) with Eli Lilly and Company ("Lilly").

Sonefpeglutide is a novel drug candidate incorporating Hanmi's proprietary long-acting platform technology, LAPSCOVERY™. Hanmi has previously received FDA marketing approval for a biologic incorporating its LAPSCOVERY platform and is currently conducting additional global clinical trials for five other programs utilizing the same platform.

Hanmi has focused on the biological functions of glucagon-like peptide 2 (GLP-2) - including the promotion of intestinal growth, reduction of inflammation, and protection and regeneration of the intestinal mucosa - and has demonstrated these effects through a range of non-clinical studies. The company has also presented the therapeutic potential of ^LAPSGLP-2 across multiple indications at major scientific conferences. Hanmi is currently conducting a global Phase 2 clinical trial in short bowel syndrome (SBS).

Hanmi will continue to conduct the ongoing global Phase 2 trial in SBS through completion while Lilly will explore additional clinical trials for sonefpeglutide based on its nonclinical and clinical data.

Through this agreement, Lilly will obtain exclusive rights to develop, manufacture and commercialize sonefpeglutide worldwide, excluding Korea.

Juhyun Lim, Vice Chairman of Hanmi, stated, "It is highly meaningful that Lilly—one of the most closely watched innovators globally—has highly recognized the development potential for sonefpeglutide." She added, "Hanmi will continue to advance innovative drug development, guided by our mission of 'Respect for People and Value Creation.'"

Under the agreement, Hanmi will receive an upfront payment of USD 75 million and may receive up to an additional USD 1.185 billion in clinical development, regulatory approval and commercialization milestone payments. In addition, Hanmi will be eligible to receive royalties following product launch.