Eli Lily's Mounjaro (tirzepatide), the first once-weekly GIP·GLP-1 receptor agonist, will enter the market with its diabetes and obesity indications.

Unlike already launched Wegovy (semaglutide), Mounjaro has two indications: diabetes and obesity.

Experts anticipate that Mounjaro's sales strategy will be focused on diabetes treatment although a separate indication is not a chief factor for medication choice in clinical practices.

Mounjaro is a single molecule that activates both GIP and GLP-1 receptors, which are primary incretin hormones that stimulate insulin secretion in the body.

Mounjaro received the Ministry of Food and Drug Safety (MFDS) approval for the treatment of type 2 diabetes in June 2023. In August, it added an indication to treat chronic weight management, resulting in two indications.

Mounjaro generated significant sales in the global market, so it has high expectations for the Korean market.

Mounjaro's sales in Q3 amounted to US$3.11 billion (KRW 4.29 trillion), an increase from US$1.41 billion (KRW 1.9683 trillion) last year. Zepbound recorded US$1.26 billion (KRW 1.73 trillion).

In South Korea, 73.6% of patients with diabetes are overweight and obesity patients. Therefore, the analysis suggests that Mounjaro has a high potential.

Hyuk-Sang Kwon, Korean Diabetes Association (Endocrinology at The Catholic University of Korea Yeouido St. Mary's Hospital), said that "Type 2 diabetes patients with obesity must be treated with a goal of improving glycated hemoglobin and weight loss." Kwon explained, "Still, many type 2 diabetes in South Korea have difficulty managing glycated hemoglobin (HbA1c) and body mass index (BMI). We need a proactive treatment to improve treatment prognosis."

SungHee Choi, Korean Diabetes Association (Endocrinology at Seoul National University Bundang Hospital), said, "Mounjaro is administered as an adjuvant treatment to dietary therapy and physical therapy to improve regulation of blood sugar in adult patients with type 2 diabetes." Choi said, "Wegovy with semaglutide was recently launched. It is said that Mounjaro is positioned as the treatment for obesity rather than diabetes, but in my opinion, it must be focused as a diabetes treatment."

Lily Korea says that the company is preparing for reimbursement before announcing the launch date.

"We are closely discussing with the Ministry of Health and Welfare (MOHW) for reimbursement, and we have invested over US$20 billion in the past four years to expand production and distribution capacities," Lily's representative said. "In South Korea, we are putting our best efforts into supplying Mounjaro stably."

Clinical practices point out high costs as a barrier. The company is expected to determine a launch date after weighing the options for reimbursement strategy and the possibility of a non-reimbursement.

As the domestic distributor candidates for Mounjaro are being discussed, the industry anticipates the launch date of Mounjaro in the first half of 2025. It is said that Mounjaro will enter the market before Wegovy launches and has a market-dominating effect.

Meanwhile, the latest Mounjaro's SURMOUNT-1 study results will positiviely affect obtaining reimbursement.

Sub-group analysis of adults who participated in the randomized Phase 3 SURMOUNT-1 trial showed that the risk of diabetes progression was reduced by 94% after patients were treated with Mounjaro for about 3 years.

The average rate of weight loss during the treatment was 15.4-22.9% for the Mounjaro group, and the average weight was reduced by 34.6~54.2lb from about 236.8lb. Mounjaro's weight loss effects observed in the early treatment stage were maintained throughout the study period.