Hanmi Pharmaceutical will license a next-generation obesity drug candidate designed to reduce body weight while preserving muscle to Genentech, a subsidiary of Swiss drugmaker Roche, in a deal worth up to 3.2 trillion won ($2.3 billion).
Hanmi said in a regulatory filing on the 24th that it had signed an exclusive licensing agreement with Genentech for HM17321, a candidate to treat metabolic diseases including obesity, type 2 diabetes and cardiovascular disease. Under the deal, Genentech secured exclusive rights to develop, manufacture and commercialize HM17321 worldwide, excluding Korea.
Hanmi will receive a non-refundable upfront payment of $190 million (about 262.9 billion won). The total deal size, including milestone payments tied to clinical development, regulatory approval and commercialization, reaches up to $2.31 billion (about 3.19 trillion won). Hanmi will also separately collect tiered royalties linked to sales after the product's launch.
HM17321 is a urocortin-2 (UCN2) analog that works through a different mechanism from the existing incretin class based on glucagon-like peptide (GLP)-1, which regulates appetite and blood sugar. It is being developed as a potential first-in-class drug that addresses a limitation of existing treatments, which reduce lean body mass, including muscle, during weight loss.
In preclinical studies, HM17321 showed effects on weight loss and body composition both when administered alone and in combination with GLP-1 class treatments. As a peptide-based treatment, it holds potential for broader development, such as a fixed-dose combination combining it with a GLP-1 treatment in a single product or as a combination therapy.
Hanmi received approval for its investigational new drug application from the U.S. Food and Drug Administration (FDA) last November and is currently conducting a Phase 1 trial in healthy adults and obese patients. The trial evaluates safety, tolerability, pharmacokinetics and pharmacodynamics. After Hanmi completes the Phase 1 trial, Genentech will lead subsequent development from Phase 2.
Choi In-young, senior vice president at Hanmi Pharmaceutical, stressed that "obesity treatment is evolving beyond simple weight loss toward improving body composition and restoring metabolic health." Choi added that the deal is "recognition in the global market of HM17321's differentiated mechanism of action and development potential."
