Hanmi Pharm Signs Up to $2.3 Billion Genentech Deal for Obesity Candidate HM17321

Hanmi Pharm has entered into an exclusive licensing agreement with Genentech, a member of the Roche Group, for the development, manufacturing and commercialization of HM17321, an investigational metabolic drug candidate being developed for obesity and associated conditions, including type 2 diabetes and cardiovascular diseases.

Under the agreement, Genentech will obtain exclusive rights to HM17321 worldwide except South Korea. Hanmi will complete the candidate’s ongoing Phase 1 clinical development, after which Genentech will assume development responsibilities beginning with Phase 2.

Non-Incretin Mechanism of Action

HM17321 is a proprietary urocortin-2 (UCN2) analog designed to selectively activate the corticotropin-releasing factor 2 (CRF2) receptor. Hanmi describes it as a long-acting UCN2 analog being developed to reduce fat mass while preserving or increasing lean mass.

The mechanism differentiates HM17321 from established incretin-based obesity treatments, including GLP-1-based therapies. Hanmi is developing the candidate as a potential first-in-class approach focused not only on weight reduction but also on body composition.

Preclinical Body-Composition Findings

Preclinical studies have reported reductions in body weight and fat mass with preservation or increases in lean mass in obese animal models. Hanmi has also presented non-human-primate data showing selective fat reduction with preserved lean mass.

The company is also evaluating HM17321 in combination with incretin-based therapies. These studies are intended to assess whether the non-incretin mechanism can complement existing obesity treatments.

These findings remain preclinical and do not establish the safety or efficacy of HM17321 in humans.

Phase 1 Clinical Trial

Hanmi received U.S. FDA Investigational New Drug clearance for HM17321 in November 2025 and subsequently initiated a Phase 1 clinical study in the United States.

The ongoing study, is a randomized, double-blind, placebo-controlled Phase 1 trial (NCT07219589) evaluating single and multiple ascending doses of subcutaneous HM17321 in healthy participants and people with obesity. The study is designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics and is expected to enroll approximately 90 participants.

The study includes a single-ascending-dose component in healthy participants and a multiple-ascending-dose component in healthy participants with obesity. The latter evaluates once-weekly subcutaneous dosing over 12 weeks.

Development Transition

Hanmi will remain responsible for completing the ongoing Phase 1 clinical trial. Following completion, Genentech will take over development beginning with Phase 2 clinical trials.

The agreement gives Genentech access to an investigational obesity candidate with a mechanism distinct from incretin-based therapies, while Hanmi retains rights in South Korea.

$2.3 Billion Potential Deal

Under the licensing agreement, Hanmi will receive $190 million upfront from Genentech. Including development, regulatory and commercial milestone payments, the total value of the transaction could reach approximately $2.3 billion. Hanmi will additionally be eligible for tiered royalties on future product sales following commercialization.

In-Young Choi, Senior Executive Vice President and Head of the R&D Division at Hanmi Pharm, said the obesity-treatment paradigm is evolving beyond weight reduction toward improving body composition and restoring metabolic health.

Boris L. Zaïtra, Head of Roche Corporate Business Development, said Roche and Genentech will pursue HM17321 as a differentiated approach aimed at selectively reducing fat mass while improving muscle mass and muscle function.

Path Forward

The immediate priority for HM17321 is completion of the Phase 1 clinical program. The study will provide initial human data on the candidate’s safety, tolerability and pharmacological profile.

Whether the body-composition effects observed in preclinical studies translate into meaningful clinical benefits will depend on results from subsequent human trials. HM17321 therefore remains an investigational candidate, with its potential as a first-in-class non-incretin obesity treatment yet to be established clinically.

Reference

Hanmi Pharm Signs Exclusive Licensing Deal with Genentech for Novel Obesity Therapy | Hanmi Pharmaceutical