Hanmi Pharmaceutical is sharpening its next-generation pipeline by changing and expanding the target indications of candidate treatments returned by global companies.

Hanmi Pharm said Monday that it had begun preparations to launch efpeglenatide, which it has been developing as a treatment for metabolic diseases in a once-weekly injection formulation, as a treatment for obesity. The company submitted an IND (investigational new drug) application to the Ministry of Food and Drug Safety last month to proceed with phase 3 clinical trials.

Efpeglenatide is a new drug candidate that Hanmi signed a licensing agreement with global pharmaceutical giant Sanofi in 2015. Sanofi returned the rights to Hanmi in June 2020 after conducting five global phase 3 studies involving more than 6,000 patients with metabolic diseases.

Despite the return of the technology, Hanmi emphasized that Sanofi presented eight oral presentations of the clinical results at the American Diabetes Association (ADA) in June 2021, recognizing the potential of efpeglenatide. The presentation was also published in the New England Journal of Medicine (NEJM)., it added.

Accordingly, Hanmi plans to develop efpeglenatide as an obesity treatment of the GLP-1 (glucagon-like peptide-1) family, which has recently been spotlighted. The company revealed its goal to develop it as a “Korean-customized GLP-1” optimized for Korean obesity standards (body mass index 25kg/㎡).

Imported GLP-1 obesity drugs are costly as they don’t get insurance coverage, and the timing of their arrival in the Korean market is unclear due to the global supply shortage.

Against this backdrop, Hanmi says that efpeglenatide can offer a more competitive price to the market while ensuring a stable supply.

"We believe that Korean-optimized efpeglenatide will be more competitive than foreign GLP-1 obesity drugs developed for Western patients with relatively high BMI levels," said Kim Na-young, executive vice president of new product development at Hanmi. "As the innovative potential of efpeglenatide has been confirmed through large-scale global clinical trials, we plan to conduct clinical trials in Korea quickly and launch it in the domestic market as soon as possible."

This is not the first time Hanmi has repurposed a drug candidate returned by its global partners. In June, Hanmi identified BTK inhibitor poseltinib (HM71224) as a potential treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Interim results from the phase 2 study of the three-drug combination, including poseltinib, were presented at the European Society of Hematology in Frankfurt, Germany.

Poseltinib is a new drug candidate that Hanmi exported to Eli Lilly in 2015, transferring worldwide rights except for Korea, with a total payment of $765 million (about 850 billion won). However, Lilly returned the development and commercialization rights in January 2019 after failing to confirm efficacy in the phase 2 rheumatoid arthritis trial.

In October 2021, Hanmi signed a joint development agreement with Genome Opinion to confirm the therapeutic effectiveness of a three-drug combination therapy combining poseltinib, CD3xCD20 bispecific antibody glopitumumab, and immunomodulator lenalidomide.

Besides, Hanmi has changed the target indication of the obesity and diabetes drug efinopegdutide (HM12525A), which was returned by Janssen in 2019, to non-alcoholic steatohepatitis (NASH) and transferred the technology to MSD in 2020. A phase 2b study is underway in Korea to compare the efficacy of NASH treatment with semaglutide.

"The development of efpeglenatide to treat obesity is one of the strategies that falls under the 'medium-term' category of Hanmi Group's recently announced R&D mid- to long-term plan, and Hanmi Group plans to invest the resources generated from this to focus on the R&D of innovative new drugs," Hanmi Pharmaceutical said.