[Edaily Reporter KIM JI-WAN ] HanmiPharm(128940)announced on the 24th that it has signed an exclusive licensing agreement with Genentech, a subsidiary of the Roche Group, for “HM17321 (UCN2 analog),” an innovative new drug candidate for the treatment of metabolic disorders such as obesity, type 2 diabetes, and cardiovascular disease. Under this agreement, Genentech secures exclusive rights to the development, manufacturing, and commercialization of HM17321 worldwide, excluding South Korea.

HM17321 is a non-incretin UCN2 (Urocortin-2) analog developed in-house by HanmiPharm and is being developed with the goal of becoming the first-in-class drug capable of simultaneously achieving weight loss and muscle preservation. While existing GLP-1-based incretin-class obesity treatments have demonstrated significant weight loss effects, a limitation has been pointed out: they are often accompanied by a reduction in lean body mass during treatment.

In preclinical studies, HM17321 demonstrated excellent results in terms of weight loss and improvements in body composition, both when administered alone and in combination with GLP-1-based therapies. Furthermore, as it is being developed as a peptide-based therapy, there is potential for future development as a fixed-dose combination (FDC) with incretin-based therapies and for expansion into combination therapy strategies.

In November 2025, HanmiPharm received approval from the U.S. FDA for an Investigational New Drug (IND) application for HM17321’s Phase 1 clinical trial and is currently conducting a Phase 1 trial to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adults and obese patients. HanmiPharm plans to complete the Phase 1 clinical trial, after which Genentech will take over development starting with Phase 2.

Choi In-young, Executive Vice President of HanmiPharm (Head of Future Growth Division), stated, “The paradigm of obesity treatment is evolving beyond simple weight loss to include body composition improvement and the restoration of metabolic health.” She added, “We find it deeply meaningful that HM17321’s differentiated scientific mechanism and development potential have been recognized by the global market. HanmiPharm will continue to do its utmost to develop innovative new drugs so that we can provide patients with more fundamental and differentiated therapeutic value.”

Boris L. Zaitra, Head of Corporate Business Development at Roche, said, “Based on the expansion of our cardiometabolic disease pipeline and our excellent diagnostic capabilities, Roche is building an innovative portfolio capable of meeting the diverse treatment needs of patients with obesity and related diseases,” and “By acquiring this next-generation candidate with first-in-class potential from HanmiPharm, Roche and Genentech plan to pursue a differentiated therapeutic strategy that selectively reduces fat mass while improving muscle mass and function,” he stated. He added, “We will further accelerate the development of this candidate to address significant unmet medical needs in the field of obesity and metabolic diseases.”

Under this agreement, HanmiPharm will receive an upfront payment of $190 million (285 billion won) from Genentech. The total value of the agreement could reach approximately $2.3 billion (3.5 trillion won), including future clinical development, regulatory approval, and commercialization milestones. Additionally, HanmiPharm is set to receive separate royalties following the product’s launch.