Hanmi Pharmaceutical has signed an exclusive license agreement worth up to 3.5 trillion won ($2.3 billion) with Genentech, a Roche Group subsidiary, for its next-generation obesity drug candidate. The substance has been recognized for its weight loss effects as well as superior muscle preservation, raising expectations that it could become one of the key candidates in the next-generation obesity treatment market.
Hanmi Pharmaceutical announced on the 24th that it has signed an exclusive license agreement with Genentech for 'HM17321', a candidate substance for treating metabolic diseases such as obesity, type 2 diabetes, and cardiovascular diseases.
This contract is the largest in scale since Hanmi Pharmaceutical's 2015 Quantum Project supply case for a diabetes treatment worth 3.9 billion euros (approximately 5 trillion KRW at the time), which was returned after being signed with Sanofi. Within South Korea, it is the largest valid single-candidate supply contract currently in effect, excluding the 4.7 billion USD (approximately 7 trillion KRW) global rights contract for an oral Alzheimer's treatment between Aribio and Pusheng Pharmaceutical, and ABL Bio's platform supply agreement.
Genentech will be responsible for the development, manufacturing, and commercialization of HM17321 worldwide, excluding South Korea, where Hanmi Pharmaceutical retains the rights. Hanmi Pharmaceutical plans to complete Phase 1 clinical trials, after which Genentech will take over development from Phase 2 onward.
Under this agreement, Hanmi Pharmaceutical will receive an upfront payment of 190 million USD (approximately 285 billion KRW). The total contract value, including milestone payments for clinical development, approval, and commercialization, can reach up to 2.3 billion USD (approximately 3.5 trillion KRW). Additionally, the company will receive separate royalties based on sales after product launch.
HM17321 is a long-acting urocorlin-2 (UCN2) analog developed by Hanmi Pharmaceutical, belonging to the non-incretin class. It aims to be the first-in-class drug capable of simultaneously reducing body fat and preserving muscle mass.
Current GLP-1-based incretin-class obesity treatments, which dominate the obesity market, are noted for their significant weight loss effects but face limitations due to reductions in both fat and lean body mass.
In non-clinical trials, HM17321 demonstrated superior results in weight loss and body composition improvement both as a monotherapy and in combination with GLP-1 therapies. Developed as a peptide-based drug, it also has the advantage of potential future development into a fixed-dose combination (FDC) with incretin-class treatments or as a combination therapy.
Hanmi Pharmaceutical received FDA approval for its Phase 1 clinical trial plan in November of last year. It is currently conducting Phase 1 trials evaluating safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adults and obese patients.
Roche is fostering obesity and cardiometabolic diseases as a next-generation growth engine. It is developing Phase 2 clinical trials for the GLP-1 class candidate enesaplatide (CT-388) and the amylin analog petrelintide. Additionally, Roche is preparing to develop a fixed-dose combination of these two drugs. By adding Hanmi's HM17321, Roche can expand its portfolio beyond incretin and amylin mechanisms to include a non-incretin approach.
Choi In-young, Vice President and Head of Future Growth Division at Hanmi Pharmaceutical, stated, “The paradigm of obesity treatment is evolving beyond simple weight loss to improving body composition and restoring metabolic health. The significance lies in the global recognition of HM17321's differentiated scientific mechanism and development potential.”
Boris L. Zeithammer, Head of Corporate Business Development at Roche, said, “We plan to pursue a differentiated treatment strategy that selectively reduces fat mass while improving muscle mass and function. We will accelerate the development of this candidate to address the significant unmet medical needs in obesity and metabolic diseases.”
