Hanmi Pharmaceutical is licensing a next-generation obesity drug candidate that simultaneously targets weight loss and muscle preservation to Roche Group’s Genentech. The total deal value of up to $2.305 billion (approximately 3.2 trillion won) marks the largest single-asset licensing deal ever signed by a South Korean pharmaceutical and biotech company with a global big pharma.
Hanmi Pharmaceutical disclosed on the 24th that it has entered into an exclusive license agreement with Genentech for its long-acting UCN2 analog “HM17321 (LA-UCN2).” Under the terms, Hanmi Pharmaceutical will receive an upfront payment of $190 million (approximately 260 billion won), followed by milestone payments totaling $2.115 billion (approximately 2.9 trillion won) tied to clinical development, regulatory approval, and commercialization stages. After product launch, the company will also receive separate royalties linked to annual net sales.
Through this agreement, Genentech secures exclusive rights to research, develop, manufacture, and commercialize HM17321 in all global markets excluding South Korea. Hanmi Pharmaceutical will complete the ongoing Phase 1 trial, after which Genentech will lead development from Phase 2 onward. However, the deal’s effectiveness is contingent on completion of administrative procedures under the U.S. Hart-Scott-Rodino (HSR) Antitrust Improvements Act.
HM17321 is a first-in-class candidate with a mechanism entirely distinct from the GLP-1 class that currently dominates the obesity treatment market. It is a urocortin-2 (UCN2) analog that selectively activates the corticotropin-releasing factor type 2 (CRF2) receptor, developed using Hanmi Pharmaceutical’s proprietary AI and structural modeling technologies.
Existing GLP-1-based obesity treatments, despite delivering meaningful weight loss, have faced criticism for simultaneously reducing lean body mass, including muscle, during treatment. HM17321 aims to reduce body fat while actually increasing lean mass and muscle. According to Hanmi Pharmaceutical, preclinical studies demonstrated superior results in weight loss and body composition improvement both as a monotherapy and in combination with GLP-1 therapies. Designed as a peptide-based molecule, the candidate also leaves open the possibility of developing fixed-dose combinations (FDCs) with incretin-class drugs in the future.
Hanmi Pharmaceutical received FDA approval for the HM17321 Investigational New Drug (IND) application in November last year and is currently evaluating safety, tolerability, and pharmacokinetics in healthy adults and obese patients.
Choi In-young, Vice President of Hanmi Pharmaceutical, said, “The obesity treatment paradigm is evolving beyond simple weight loss toward body composition improvement and metabolic health restoration. HM17321’s differentiated scientific mechanism and potential have been recognized in the global market.” Boris L. Zaïtra, Head of Roche Corporate Business Development, stated, “We plan to pursue a differentiated therapeutic strategy that selectively reduces fat mass while improving muscle mass and muscle function.”
Hanmi Pharmaceutical explained that it has no obligation to pay penalties upon contract termination, nor any obligation to return already-received upfront payments and milestones. The company emphasized that while failure to achieve clinical, regulatory, or commercial success could result in forfeiting milestone payments at those stages or contract termination, its financial downside risk is limited.
This deal represents Hanmi Pharmaceutical’s largest single-transaction achievement since its multi-asset agreement with Sanofi in 2015. It once again validates the company’s strategy of monetizing its pipeline through partnerships with global big pharma. As the obesity drug market experiences explosive growth centered on GLP-1 therapies from Novo Nordisk and Eli Lilly, attention is focused on whether latecomers with differentiated indications such as muscle preservation can reshape the competitive landscape.