Hanmi Pharm headquarters. [Hanmi Pharm]
Hanmi Pharm headquarters. [Hanmi Pharm]

Hanmi Pharm has licensed its internally developed next-generation obesity drug candidate to Genentech, a subsidiary of the Roche Group, in the largest licensing deal ever recorded for a single drug candidate in Korean pharmaceutical and biotech history.

The deal surpasses Hanmi Pharm's own previous record set in 2015, when a string of landmark licensing agreements shook the global biotech industry, and marks the company's biggest research and development achievement since the death of its founder and late chairman Lim Sung-ki. The drug candidate's novel mechanism addresses muscle loss — long considered the most critical drawback of existing glucagon-like peptide-1 (GLP-1) therapies — and could prove a turning point in the next-generation obesity treatment market.

Hanmi Pharm announced Monday that it had signed an exclusive licensing agreement with Genentech covering HM17321, a UCN2 analog and innovative drug candidate for the treatment of obesity and metabolic diseases.

Under the agreement, Genentech gains exclusive rights to develop, manufacture and commercialize HM17321 in all markets outside South Korea. Hanmi Pharm will receive a confirmed upfront payment of $190 million, equivalent to 285 billion won, with the total deal value reaching up to $2.3 billion including milestone payments tied to development, regulatory approval and commercialization. Hanmi Pharm will also receive separate royalties on net sales after commercialization.

The deal carries deep symbolic weight in Hanmi Pharm's more than 50-year research and development history. In 2015, the company signed a series of major licensing agreements — including the Quantum Project with France's Sanofi worth 3.9 billion euros ($4.55 billion), as well as deals with Janssen, Eli Lilly and Germany's Boehringer Ingelheim — generating a total of 8 trillion won in technology exports in a single year and cementing Hanmi Pharm's reputation as a licensing powerhouse.

Several of those agreements, including the Sanofi Quantum Project and deals with Janssen and Boehringer Ingelheim, were later returned — a painful but formative setback. Hanmi Pharm continued investing in research and development and deepening its proprietary pipeline. The result is a deal that surpasses all previous records on a single-candidate basis and demonstrates the global research and development competitiveness of the company's post-Lim era, as the largest commercialization achievement built on its own technology since the founder's passing.

HM17321 is a non-incretin UCN2 (urocortin-2) analog developed entirely in-house by Hanmi Pharm, and is a first-in-class drug candidate designed to reduce body weight and preserve muscle mass simultaneously. Leading incretin-based obesity drugs on the market — including Wegovy and Mounjaro — have faced persistent criticism for causing significant loss of lean body mass, including muscle, alongside fat reduction.

In preclinical studies, HM17321 demonstrated weight loss and muscle preservation effects even when administered alone. When combined with existing GLP-1 agents, it dramatically improved body composition while enhancing weight-loss outcomes. As a peptide-based compound, it also holds broad potential for future development as a fixed-dose combination product. Hanmi Pharm received FDA approval for a Phase 1 trial investigational new drug application in November last year and is currently conducting the trial; from Phase 2 onward, Genentech will lead global development.

The licensing deal is the largest ever for a single drug candidate in the Korean pharmaceutical industry, and its significance extends beyond scale. It comes at an inflection point in the global obesity market, where the paradigm is shifting from simple weight reduction to body composition improvement centered on muscle preservation — and it represents global validation of Hanmi Pharm's proprietary research and development capabilities as a new standard in that space.

"The paradigm of obesity treatment is evolving beyond simple weight loss toward improving body composition and restoring metabolic health," said Choi In-young, executive vice president and head of future growth at Hanmi Pharm. "With HM17321's differentiated scientific mechanism and development potential now recognized in the global market, we will do our utmost to advance innovative new drug development."

Boris L. Zeistra, head of corporate business development at Roche, said the company plans to pursue a differentiated treatment strategy by in-licensing a next-generation candidate with first-in-class potential from Hanmi Pharm, targeting selective reduction of fat mass while improving muscle mass and function.


silverpaper@heraldcorp.com