As more people are living with obesity in the world, obesity treatment is gaining popularity. According to the World Obesity Federation report, more than half of the world's population in 2035, 10 years from now, will be categorized as overweight or obese. South Korea is projected to have a similar rate.

At the end of last year, Novo Nordisk's obesity drug 'Wegovy (semaglutide),' which gained popularity and was in short supply in the global market, was finally introduced to clinical practices in South Korea.

After that, new drugs with significant weight-loss effects are being introduced into South Korea, indicating a shift in the paradigm of obesity treatment. The companies have applied for expanded indications for these drugs, influencing clinical areas.

According to pharmaceutical industry sources on January 6, Novo Nordisk Korea has been supplying 'Wegovy Prefilled Pen Inj' to clinical practices since mid-October last year.

Wegovy received domestic marketing authorization in April with indications to aid weight-loss overweight patients who have a Body Mass Index (hereafter referred to as BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and having one or more weight-related accompanying diseases.

Additionally, in July 2024, Wegovy also receive approval for the indication to reduce risks of major cardiovascular events (death from cardiovascular diseses, non-fatal cardial infarction, or non-fatal cerebral strok) in overweight or obese patients with early BMI of 27 kg/m² or higher with cardiovascular diseases.

Upon the launch of Wegovy, Novo Nordisk Korea actively worked to secure market dominance in the Korean obesity treatment market, using about 80 sales and marketing employees. As a result, Wegovy is currently being used in medical clinics as a non-reimbursable drug. Patients pay an average cost of KRW 700,000-800,000 per month for treatment.

"Japan's drug price seems to be the world's lowest, but it is covered by insurance. It has been launched as the lowest price globally among non-reimbursed drugs," Chul Jin Lee, President of the Korean Society for the Study of Obesity (Joeun Family Health Clinic), said. "It is likely that the company has considered the potential launch of Mounjaro (tirzepatide) in Korean clinical practices."

Wegovy's company seems to be attempting to dominate the market by entering the domestic clinical field ahead of Mounjaro.

The industry's interest is now on the launching date of 'Mounjaro,' known as Wegovy's rival. Lily Korea plans to introduce the drug to clinical practices in South Korea this year.

In addition to Mounjaro's approval for type 2 diabetes, Lily Korea received extended approval for the drug as an adjuvant therapy for chronic weight control, which is similar to Wegovy. Although it is being sold in the market for obesity treatment as the product name 'Zepbound,' Mounjaro will be used for treating diabetes and obesity in South Korea.

Regarding this, Lily's recent announcement of the top-line results of the open-label SURMOUNT-5 Phase 3 clinical trial draws attention. This study directly compared the effects of Mounjaro to Wegovy.

According to the results presented, patients treated with Mounjaro had greater weight loss effects compared to those treated with Wegovy. This finding indicates that Mounjaro is superior in a one-on-one comparison to Wegovy.

In the clinical study involving 751 patients who are obese or overweight without diabetes, patients treated with Mounjaro for 72 weeks had a weight loss of 22.67kg, which is an average loss of 20.2% of the body weight.

During the same period, patients treated with Wegovy had a weight loss of 13.7% (14.96kg). When the weight loss range was compared, Zepbound showed about 47% superior effects than Wegovy.

Consequently, when Mounjaro becomes available in the Korean market, Wegovy will likely face a short-lived 'popularity.'

"Mounjaro in the form of vial is under consideration of domestic approval," Lee said. "Mounjaro's yearly cost is about KRW 3 million less than what Wegovy costs. Moreover, the drug price of vial formation saw a 50% reduction in the United States. When it launches in South Korea after obtaining approval, Mounjaro will likely priced significantly less. For this reason, clinical practices are closely watching Mounjaro."

"When vial formation becomes available, doctors prefer using those than pen types," Lee added. "A weekly vial package treatment regimen would be optimal."

Due to Wegovy and Mounjaro's success, GLP-1 emerged as the R&D trend in the domestic and foreign pharmaceutical and biotech industries.

Recently, the FDA granted approval for Zepbound, containing a similar active ingredient to Mounjaro, for sleep apnea. In addition to its diabetes and obesity indications, the extended indication of sleep apnea suggests an increased volume of usage. Also, an extended indication is likely approved in South Korea.

Companies witnessing these successes are evaluating the possibility of metabolic dysfunction-associated steatohepatitis (MASH) treatment since GLP-1 improves insulin secretion and sensitivity, improving blood glucose control.

Because MASH is caused by fat buildup in the liver of people who consume little or no alcohol, weight loss can have a positive effect on patients.

For this reason, pharmaceutical companies have determined that GLP-1 can be a treatment for MASH, alongside diabetes and obesity, and are currently conducting clinical trials.

The same goes for Wegovy and Mounjaro's active ingredients, semaglutide and tirzepatide.

Novo Nordisk and Lily are assessing the clinical utility of those drugs in patients with MASH, conducting phase 2 and phase 3 clinical trials, respectively. The industry is anticipating potential extended indications.

Additionally, survodutide, under development by Boehringer Ingelheim, demonstrated clinical utility in a phase 2 trial, emerging as a new drug candidate for MASH.

The biotech industry in South Korea is also considering the possibility of new GLP-1 drugs. Many companies have begun clinical studies.

The outstanding companies are ProGen and D&D Pharmatech.

ProGen is gaining attention for its new drug development in diabetes and obesity fields. The company is developing 'PG-102,' which works bi-specifically by binding GLP-1·GLP-2.

ProGen's new drug candidate received approval from the Ministry of Food and Drug Safety (MFDS) for conducting a domestic phase 2 trial. ProGen aims to maximize the effects, such as improving intestine function, glucose uptake in adipose tissue, and alleviating chronic inflammation by targeting both GLP-1 and GLP-2.

Kun-Ho Yoon, Chief Medical Officer of Progen (Endocrinology Specialist), says the significance of the study is that "Since there have been no new drug candidates that simultaneously target both GLP-1 and GLP-2, ProGen's 'PG-102' can be a first-in-class candidate treatment."

D&D Pharmatech is conducting clinical trials for its GLP-1 agent for various fields, including MASH, Parkinson's disease, and dementia. Last year, the company initiated a Phase 2 trial after receiving the FDA approval of its Phase 2 trial Investigational New Drug (IND) application.

The Phase 2 trial is being conducted in 10 clinical trial centers, and the trial involves 68 patients who are overweight or obese with accompanying MASH. The Korean clinical practices are closely watching the D&D Pharmatech's achievements.

"D&D Pharmatech has GLP-1 and GLP-2 bi-specific agents and amylin-based products," Lee said. "The company has a competitive edge, especially having a proprietary platform for switching an agent to oral formation alongside having injectable."

"Regarding developing a GLP-1 formation, the key to success is which company could diversify with lesser cost," Lee remarked. "The success in the market competition will be determined by providing various clinical benefits at lower prices for injectable, vial, and oral formations," Lee projected.