Hanmi Pharmaceutical has signed an exclusive license agreement with Genentech, a subsidiary of Roche Group, for its innovative drug candidate HM17321 (a UCN2 analog). The deal, valued at up to approximately $2.3 billion (about 3.2 trillion won), is expected to accelerate Hanmi's entry into the global obesity treatment market.
On August 24, Hanmi Pharmaceutical announced the exclusive licensing agreement for HM17321, aimed at treating metabolic diseases such as obesity, type 2 diabetes, and cardiovascular diseases.
Under the agreement, Genentech will secure exclusive rights for the development, manufacturing, and commercialization of HM17321 worldwide, excluding South Korea. Hanmi will receive an upfront payment of $190 million (approximately 262.9 billion won), with the total contract value, including clinical development, regulatory approval, and commercialization milestones, amounting to about 3.2 trillion won. After the product launch, Hanmi will also receive separate royalties.
The upfront payment represents about 8% of the total contract value, which is notable considering that upfront payments in global licensing agreements typically account for around 5%. This is also the largest upfront payment for a single drug candidate and is significant given that HM17321 is still in Phase 1 clinical trials, according to the company.
HM17321 is a UCN2 analog developed by Hanmi Pharmaceutical, aiming to be the first-in-class drug that achieves both weight loss and muscle preservation. Existing GLP-1-based incretin obesity treatments have shown significant weight loss effects but have been criticized for accompanying reductions in lean body mass.
Preclinical studies have confirmed weight loss and body composition improvement effects, both with single-agent administration and in combination with GLP-1-based treatments. Additionally, as a peptide-based therapy, there is potential for future development of fixed-dose combination (FDC) therapies with GLP-1 agents.
Last November, Hanmi received approval from the U.S. Food and Drug Administration (FDA) for the Phase 1 clinical trial application (IND) for HM17321, and is currently conducting Phase 1 trials to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adults and obese patients. Genentech will take over development starting from Phase 2 trials.
Choi In-young, Vice President and Head of Future Growth at Hanmi Pharmaceutical, stated, "We are honored that the differentiated scientific mechanism and development potential of HM17321 have been recognized in the global market. We will do our utmost to provide patients with more fundamental and differentiated therapeutic value through innovative drug development."
Meanwhile, the company is preparing for the commercialization of its GLP-1 obesity drug 'Epe' within this year, centered around its new drug development project 'H.O.P (Hanmi Obesity Pipeline)'. Earlier this year, Hanmi also achieved technology export success by signing a licensing agreement with Eli Lilly for the development, manufacturing, and commercialization of its biopharmaceutical candidate 'Sonepeglutide'.
* This article has been translated by AI.
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