Hanmi Pharm "Once-Weekly GLP-1 Obesity Treatment, Phase 3 Clinical Trial Approved"

Korean-Optimized Obesity Drug 'Epeglenaide'
Phase 3 Approval 3 Months After IND Submission
Clinical Development to Begin Late This Month... Commercialization Targeted Within 3 Years

Hanmi Pharmaceutical announced on the 23rd that it has obtained approval from the Ministry of Food and Drug Safety (MFDS) for the Phase 3 clinical trial plan of 'Epeglenatide (development code HM11260C),' a glucagon-like peptide-1 (GLP-1) receptor agonist drug developed in-house.

Exterior view of Hanmi Pharmaceutical headquarters. [Photo by Hanmi Pharmaceutical] [Image source=Yonhap News]

Epeglenatide is a once-weekly formulation GLP-1 receptor agonist that acts as an analog of the GLP-1 hormone, which helps insulin secretion and appetite suppression in the body. Originally developed as a treatment for type 2 diabetes, this compound demonstrated weight loss and blood glucose control efficacy in global Phase 3 clinical trials conducted after its technology was licensed out to the global pharmaceutical company Sanofi in 2015. At the same time, it significantly reduced the incidence of major cardiovascular and renal diseases, with these results published in numerous academic journals. The related rights to Epeglenatide were returned to Hanmi Pharmaceutical in 2020.

Hanmi Pharmaceutical, which submitted an Investigational New Drug (IND) application to the MFDS in July, emphasized that it was able to receive rapid approval through various development support programs operated by the MFDS. First, through close one-on-one consultations under the MFDS's 'Global Innovative Fast Track (GIFT)' system, it established a biopharmaceutical development strategy and conducted a customized consultation program for recombinant drugs for additional product development consulting. Through this, Hanmi Pharmaceutical secured close communication opportunities with regulatory authorities regarding the clinical and approval strategies for Epeglenatide and was able to resolve a significant portion of anticipated challenges in advance, according to the company.

Hanmi Pharmaceutical plans to rapidly commercialize Epeglenatide as a 'GLP-1 obesity treatment optimized for Koreans.' Given that the potential of Epeglenatide has been confirmed through global clinical trials, the company intends to proceed with accelerated clinical development aiming for domestic commercialization within three years.

Epeglenatide will be produced at Hanmi Pharmaceutical's dedicated biopharmaceutical factory, the 'Pyeongtaek Smart Plant.' Hanmi Pharmaceutical explained that, unlike imported products experiencing supply shortages, stable supply will be possible through this facility, and the drug can be supplied at a more economical cost.

Meanwhile, Hanmi Pharmaceutical recently launched the 'H.O.P Project,' which seeks a full-cycle treatment approach from obesity treatment to management and prevention. Epeglenatide is the first commercialization model of H.O.P.

The H.O.P Project includes, besides Epeglenatide, ▲ LA-GLP/GIP/GCG, which has shown effects comparable to surgical weight loss methods ▲ a biopharmaceutical that can prevent muscle mass loss and help suppress rebound effects during GLP-1 therapy ▲ an eating disorder improvement agent ▲ oral obesity treatments ▲ and digital therapeutics applicable to obesity prevention and management.

Hanmi Pharm H.O.P Project.
[Image provided by Hanmi Pharm]

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