Hanmi Pharm Secures $1.26 Billion Deal with Eli Lilly for GLP-2 Analog Sonefpeglutide in Global Licensing Agreement

Hanmi Pharm. Co., Ltd. (“Hanmi”) announced a strategic global licensing agreement with Eli Lilly (NYSE: LLY) for the development, manufacturing, and commercialization of sonefpeglutide, Hanmi’s novel LAPS GLP-2 analog biologic drug candidate. Under the terms, Lilly acquires exclusive worldwide rights (excluding Korea) to the asset, while Hanmi retains responsibility for completing its ongoing global Phase 2 trial in Short Bowel Syndrome (SBS). The deal includes a $75 million upfront payment and potential milestone payments totaling up to $1.185 billion, plus royalties on future sales.

Transaction Details

Asset Profile & Development Status

• Molecule: Sonefpeglutide – novel GLP-2 analog leveraging Hanmi’s LAPSCOVERY long-acting platform technology
• Primary Indication: Short Bowel Syndrome (SBS) – currently in global Phase 2 clinical development
• Platform Advantage: LAPSCOVERY technology extends half-life and reduces dosing frequency compared to conventional GLP-2 analogs
• Development Responsibilities:
• Hanmi: Complete ongoing global Phase 2 SBS trial
• Lilly: Explore additional clinical indications based on existing nonclinical and clinical data
• Therapeutic Potential: GLP-2 analogs promote intestinal mucosal growth and nutrient absorption, addressing unmet needs in gastrointestinal disorders

Strategic Rationale & Market Opportunity

The partnership leverages complementary strengths between the Korean innovator and global pharmaceutical leader:

For Hanmi:

• Capital Infusion: Immediate $75 million strengthens balance sheet for other pipeline programs
• Global Development Expertise: Access to Lilly’s extensive clinical development and regulatory capabilities
• Commercial Scale: Partnership with established leader in metabolic diseases ensures optimal market penetration
• Risk Mitigation: Transfers late-stage development costs and commercialization risks to Lilly

For Lilly:

• Pipeline Expansion: Adds novel GLP-2 mechanism to complement existing metabolic disease portfolio
• Platform Validation: Gains access to Hanmi’s proprietary LAPSCOVERY long-acting technology
• First-Mover Potential: Opportunity to establish leadership in underserved gastrointestinal therapeutic areas
• Strategic Optionality: Rights to explore multiple indications beyond initial SBS focus

“This landmark agreement validates our LAPSCOVERY platform and sonefpeglutide’s potential to address significant unmet medical needs,” said Dr. Kwon Seung-hwan, Chief Executive Officer of Hanmi Pharm. “Partnering with Lilly, a global leader in metabolic diseases, ensures that sonefpeglutide will reach patients worldwide with optimal development resources and commercial expertise.”

Financial Impact & Industry Context

The $1.26 billion total deal value represents one of the largest outbound licensing agreements from a Korean biotech company:

• Milestone Structure: Payments tied to clinical progress, regulatory approvals across major markets (US, EU, Japan), and commercial sales thresholds
• Royalty Terms: Expected mid-to-high single-digit royalty rates on net sales
• Market Potential: GLP-2 analog market projected to reach $3–5 billion annually by 2030, driven by SBS and potential expansion into inflammatory bowel disease (IBD) and other gastrointestinal disorders
• Competitive Landscape: Sonefpeglutide competes with Takeda’s teduglutide (Gattex/Revestive), the current standard of care for SBS

Industry analysts view the deal as transformative for Hanmi, providing substantial non-dilutive funding to advance its broader pipeline while establishing a strategic partnership with a top-tier global pharmaceutical company.

Forward‑Looking Statements
This brief contains forward-looking statements regarding licensing agreements, clinical development plans, and financial projections. Actual results may differ due to clinical trial outcomes, regulatory decisions, and market dynamics.-Fineline Info & Tech