A Hanmi Jackpot After 11 Years... New Mechanism Pays Off

From Platform Technology to Obesity-Focused Strategy
Achievement in Three Years of the H.O.P Project

Hanmi Pharmaceutical's technology transfer of a novel obesity drug candidate to Genentech, a subsidiary of the Swiss Roche Group, is seen as particularly significant, as it demonstrates competitiveness against global pharmaceutical powerhouses in the race for next-generation mechanisms.

Hanmi Pharmaceutical.

The 'Quantum Project' technology transfer to Sanofi in 2015, valued at 3.9 billion euros (approximately 4.8 trillion won at the time), was an improvement in technology aimed at enhancing the persistence of existing glucagon-like peptide-1 (GLP-1) therapies. In contrast, the recent agreement involves a candidate based on a novel mechanism that has not yet been commercialized, highlighting Hanmi Pharmaceutical's advanced R&D capabilities. The contract with Genentech is worth a total of 2.3 billion dollars (about 3.5 trillion won), making it Hanmi Pharmaceutical's largest single-asset technology transfer to date.

According to the pharmaceutical industry on August 25, the obesity drug candidate HM17321 recently out-licensed to Genentech is a non-incretin novel drug that stimulates corticotropin-releasing factor receptor type 2 (CRF2). It has the potential to become the first-in-class drug in its category, able to achieve both weight loss and muscle preservation or increase simultaneously.

Next-Generation Obesity Drug Targets 'Qualitative Weight Loss'

To demonstrate the competitiveness of its candidate compound, Hanmi Pharmaceutical targeted various areas for improvement over existing GLP-1 therapies, which currently dominate the market. In June, the company simultaneously presented findings from seven related studies at the American Diabetes Association (ADA) annual scientific sessions, significantly strengthening its preclinical evidence base.

In non-clinical studies of HM17321, a four-week administration to obese mice resulted in up to 17.5% weight loss. Body fat decreased by over 40%, while muscle mass increased and grip strength and other muscle functions were improved as well. Unlike existing drugs that only increase muscle mass, this agent improved both the quantity and quality of muscle. When used in combination with an amylin-class obesity drug, fat reduction increased to a maximum of 56.5%—without appetite suppression—and muscle mass gain doubled compared to HM17321 monotherapy. This confirms that drugs with different mechanisms can yield benefits without added side effects.

The efficacy of HM17321 was also validated in metabolic disease models. In hypertensive rats, four months of administration lowered blood pressure and heart rate, and the decline in renal function seen in semaglutide (active ingredient of Wegovy) groups was prevented. Regarding heart failure, HM17321 improved ventricular hypertrophy and diastolic function, and in particular, lowered blood pressure in obese monkeys without increasing heart rate. The compound also improved joint and muscle structure and function in models of osteoarthritis, osteoporosis, and age-related sarcopenia.

Strategy to Build a Pipeline Centered on 'Obesity as a Disease'

Hanmi Group's R&D strategy, aimed at supplementing shortcomings of existing therapies, is an extension of the ambitious 'H.O.P. (Hanmi Obesity Pipeline)' project unveiled in 2023. The portfolio includes cost-effective GLP-1 agents, next-generation triple agonists, new drugs to prevent muscle loss, oral formulations, and digital therapeutics, covering obesity prevention, treatment, and post-treatment management. HM17321, now out-licensed, was developed specifically to prevent muscle loss as part of this pipeline.

Launched in the midst of leadership concerns following the passing of founder Lim Sung-ki in 2020, the H.O.P. project was interpreted as evidence that the group's commitment to new drug development remains unwavering. Whereas Hanmi Pharmaceutical previously grew by developing platform technologies applicable to multiple diseases, the H.O.P. project takes the opposite approach by focusing on obesity as a singular disease area and securing candidates with various mechanisms and formulations within it. This latest technology transfer marks the first instance in which the market has recognized the value of Hanmi Pharmaceutical's shift in R&D strategy.

Expectations are growing that the 'Hanmi Jackpot' will not be a one-off event. In addition to Efeglenatide (product name: Ephe), developed through the H.O.P. project and slated for release later this year, Hanmi Pharmaceutical has several next-generation candidates in the pipeline—including the triple agonist HM15275 in Phase 2 clinical trials for obesity and type 2 diabetes, an eating disorder treatment, and an oral GLP-1 agent. With the effectiveness of the H.O.P. strategy now validated in the market, these pipeline assets are drawing attention as the next major out-licensing candidates.

A Hanmi Pharmaceutical spokesperson said, "This technology transfer achievement is the result of our determination to carry on the value of R&D, even amid the turbulent circumstances following the passing of our former chairman."

This content was produced with the assistance of AI translation services.