KB News Desk
Hanmi Pharmaceutical said Monday it has inked an exclusive licensing agreement with Genentech for its obesity drug candidate HM17321 in a deal that could be worth up to $2.3 billion, setting new record for the firm for a licensing contract of a single drug candidate.
Under the contract, Hanmi will receive an upfront payment of $190 million from Genentech, a US biotechnology subsidiary of Swiss multinational pharmaceutical giant Roche.
The total value of the deal could reach as much as $2.3 billion, including development, regulatory and commercialization milestones. Hanmi Pharmaceutical will also be eligible to receive royalties on sales following the product’s launch.
Genentech will obtain exclusive rights to develop, manufacture and commercialize HM17321 worldwide, excluding South Korea. Hanmi Pharmaceutical’s drug candidate is being developed to treat obesity and associated conditions such as type 2 diabetes and cardiovascular diseases.
HM17321 is a non-incretin Urocortin-2, or UCN2, analog independently developed by Hanmi Pharmaceutical. The Korean drugmaker is seeking to turn it into a first-in-class treatment that can simultaneously reduce body weight and preserve lean mass.
While GLP-1-based incretin therapies such as Eli Lilly’s Mounjaro and Novo Nordisk’s Wegovy have demonstrated noticeable weight-loss benefits, reductions in lean body mass during treatment have emerged as a limitation.
Hanmi Pharmaceutical said preclinical studies showed that HM17321 delivered promising results in both weight reduction and body composition when administered alone or in combination with GLP-1 therapies.
As a peptide-based drug candidate, HM17321 could also potentially be developed as a fixed-dose combination with incretin-based therapies or used as part of combination treatment strategies, according to the Korean company.
“The paradigm of obesity treatment is evolving beyond simple weight reduction toward improving body composition and restoring metabolic health,” said Choi In-young, head of R&D at Hanmi Pharmacuetical.
“We are very pleased that the differentiated scientific mechanism and development potential of HM17321 have been recognized by the global market.”
In November last year, Hanmi Pharmaceutical received the US Food and Drug Administration’s clearance for an investigational new drug application for HM17321. It is currently conducting a Phase 1 clinical trial involving healthy adults and people with obesity to assess the candidate’s safety, tolerability, pharmacokinetics and pharmacodynamics.
Hanmi plans to complete its ongoing Phase 1 trial, after which Genentech is expected to take over development, beginning with Phase 2 trials.
“By licensing this next-generation investigational therapy with first-in-class potential from Hanmi, Roche and Genentech will pursue a differentiated approach to selectively reduce fat mass while improving both muscle mass and muscle function,” said Boris L. Zaitra, head of Roche corporate business development.
“We look forward to further developing this medicine in order to address important unmet needs for people living with obesity and other metabolic diseases.”
Shares of Hanmi Pharmaceutical, which is listed on Korea’s main bourse Kopsi, jumped on the deal announcement, hitting the daily upper limit of 30 percent at 540,000 won ($392) as of 2 p.m.
