[Reporter’s View] K-obesity drugs need to innovate

Go beyond copying products and lead the innovation

The global obesity treatment market is expected to continue its rapid growth.

 

Novartis ‘Wegovy’ and Eli Lilly's ‘Mounjaro’ are both now entering their third year as industry game-changers.

 

Both drugs are glucagon-like peptide-1 (GLP-1) receptor agonist injections that suppress appetite and reduce weight, popularizing the recognition that obesity is not merely a cosmetic issue but a ‘disease’.

 

In Korea, momentum is building, heralding the introduction of homegrown obesity drugs.

 

Major pharmaceutical companies like Hanmi Pharmaceutical, Daewoong Pharmaceutical, and HK Inno.N have successively unveiled new candidates and initiated clinical trials.

 

Their ambition is to reduce dependence on original drugs and secure market leadership through technological self-reliance.

 

Yet, challenges remain formidable.

 

The global leaders Wegovy and Mounjaro have already secured large-scale, long-term data after receiving FDA and EMA approvals through trials involving thousands of patients.

 

Furthermore, the market's focus is shifting from injectables to oral tablets.

 

Novo Nordisk's high-dose oral semaglutide and Eli Lilly's oral low-molecular-weight GLP-1 agonist ‘Orforglipron’ have both achieved positive results in Phase III clinical trials.

 

Novo Nordisk has submitted its new drug application to the U.S.

 

Food and Drug Administration (FDA), which is expected to make a decision on approval within the fourth quarter.

 

If approved, commercialization is expected within the next year.

 

Eli Lilly's Orforglipron has been designated for FDA Fast Track review and is currently under review.

 

The company plans to apply for approval as an obesity treatment within this year and as a type 2 diabetes treatment next year.

 

With the dawn of this ‘oral obesity drug’ era, the market landscape is expected to shift, driven by the convenience of administration and high treatment adherence rates offered by the oral formulations.

 

In contrast, domestic pharmaceutical companies are still just in the entry stage.

 

Major firms like Hanmi Pharma, Dong-A ST, Daewoong Pharmaceutical, and HK Inno.N have revealed their candidates and entered clinical trials, but most are still in the injectable formulation phase.

 

Compared to global companies already advancing oral formulations to commercialization, the development speed gap is clear.

 

Disparities exist not only in technological capability but also in clinical experience, data scale, and regulatory strategies.

 

Safety and misuse are also growing concerns.

 

While GLP-1 drugs deliver dramatic appetite suppression, they’ve also been linked to gastrointestinal disorders, muscle loss, and psychiatric side effects.

 

Misuse of “weight-loss injections” has already become a social issue in both Western and Korean markets.

 

If domestic pharmaceutical companies aim to enter the market with drugs using similar mechanisms, differentiating their safety profile is as essential as efficacy.

 

Economics present another hurdle.

 

Without reimbursement, the monthly cost of Wegovy or Mounjaro ranges from KRW 200,000 to KRW 500,000, depending on dosage.

 

For a homegrown drug to succeed, it must compete with big pharma treatments through low production costs and reasonable pricing to build market dominance.

 

Still, there are signs of promise.

 

Hanmi Pharmaceutical is advancing multiple novel candidates, including the triple-action obesity treatment ‘HM15275’ that minimizes muscle loss, the muscle-building obesity treatment ‘HM17321’, and the oral GLP-1 receptor agonist obesity treatment ‘HM101460.’ Companies like Dong-A ST, Progen, and D&D Pharmatech are developing next-generation GLP-1 drugs that apply dual-action mechanisms.

 

For domestically developed drugs to truly establish themselves as ‘K-Obesity drugs,’ four elements must align: technological capability, data, ethical standards, and speed.

 

‘Homegrown’ alone will not persuade patients or markets.

 

However, if the focus is on ‘innovation’ rather than mere replication, there is ample potential for K-Obesity drugs’ success in the global market.