Hanmi Pharmaceutical said it has submitted an investigational new drug (IND) application for a phase 1 clinical trial of its obesity treatment candidate HM15275 to the Ministry of Food and Drug Safety (MFDS). Hanmi also plans to submit the IND application to the U.S. FDA this month.

HM15275 is an obesity treatment candidate, and HM11260C (efpeglenatide), a triple agonist at the GLP-1/GIP/glucagon receptor. Hanmi expects HM15275 to have therapeutic effects on obesity-related metabolic diseases, such as dyslipidemia, type 2 diabetes, and cardiovascular diseases, in addition to severe obesity.

Hanmi promotes the H.O.P. Project, which seeks to develop a full-cycle treatment for obesity, from treatment to management and prevention. In addition to HM11260C and HM15275, the company has also developed an eating disorder improvement drug, an oral obesity treatment drug, and a digital treatment drug for obesity prevention and management.

"HM15275 incorporates the research knowledge and know-how that Hanmi has accumulated over 20 years of research in the field of incretins," a Hanmi Hanmi Pharmaceutical official said. "We will do our best to develop next-generation obesity treatments that overcome the limitations of existing treatments and innovatively increase their effectiveness."

Hanmi Pharmaceutical will present the results of HM15275 at the 2024 American Diabetes Association (ADA) meeting in June.