Eli Lilly and Company and Hanmi Pharm have officially finalized a comprehensive licensing agreement. Under the terms of the worldwide arrangement, Sonefpeglutide licensing is for global development, manufacturing, and commercialization, excluding the South Korean market. The financial framework includes a $75 million upfront payment to Hanmi, with the potential for up to $1.185 billion in milestone payments linked to clinical development, regulatory approvals, and commercialization, alongside royalties following product launch.
The agreement centers on an advanced biologic drug candidate designed to address multiple clinical indications. Sonefpeglutide functions as a GLP-2 analog, focusing on the biological mechanisms of glucagon-like peptide 2. Non-clinical studies have demonstrated its capacity to promote intestinal growth, reduce inflammation, and facilitate the protection and regeneration of the intestinal mucosa.
This specific biologic drug candidate incorporates Hanmi’s proprietary long-acting platform technology, known as LAPSCOVERY™. Hanmi has previously secured FDA marketing approval for another biologic utilizing this exact long-acting platform and continues to conduct global clinical trials for five additional programs based on the same underlying technology.
Hanmi is actively conducting a global Phase 2 clinical trial assessing the formulation’s efficacy in treating short bowel syndrome (SBS). As the partnership progresses, Hanmi will maintain and complete the ongoing global Phase 2 trial for short bowel syndrome. Concurrently, Eli Lilly will leverage the existing clinical and nonclinical data to explore additional trial opportunities and indications for the GLP-2 analog.
The partnership underscores a defined focus on advancing complex therapeutic pipelines. The sonefpeglutide licensing transaction ensures that both organizations will proceed with dedicated clinical expansions. Juhyun Lim, Vice Chairman of Hanmi, remarked on the collaboration, stating that it is highly meaningful that Eli Lilly recognized globally as a closely watched innovator has acknowledged the development potential of the therapy. She noted that Hanmi will continue advancing innovative drug development in alignment with the organization’s mission of respect for people and value creation.
