Oral Obesity Drug Launched in the U.S.… Where is K-Bio Pharmaceutical Now?

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‘Wegovy Pill’ Emerges as a Game Changer… D&D Pharmatech, Il Dong Pharmaceutical, and Others Intensify Development Efforts

Denmark's Novo Nordisk announced on January 5 (local time) that its oral obesity drug 'Wegovy Pill' has been launched in the United States. Photo=Novo Nordisk

Denmark's Novo Nordisk's obesity drug ‘Wegovy Pill (ingredient name Semaglutide)’ has recently been launched in the U.S. as the first oral medication in its class. Its biggest competitor, Eli Lilly's oral obesity drug, is also in the approval process in the U.S. As the global obesity market rapidly expands, K-pharmaceutical and biotech companies, led by D&D Pharmatech, are making every effort to accelerate the development of oral obesity drugs, which are still in the early stages.

According to the pharmaceutical and biotech industry on the 9th, Novo Nordisk launched the Wegovy Pill, which is taken orally once a day, in the U.S. just about two weeks after receiving approval from the Food and Drug Administration (FDA) at the end of last month.

The Wegovy Pill is the oral version of the obesity injection ‘Wegovy’ developed by Novo Nordisk, which works through the ‘Glucagon-like Peptide (GLP)-1’ mechanism. This drug has already been distributed globally as an oral diabetes treatment called ‘Rybelsus’. It is analyzed that the rapid launch of the Wegovy Pill was possible due to the established distribution and production networks.

Industry insiders predict that the introduction of the Wegovy Pill will significantly shake up the treatment paradigm of the injection-based obesity drug market, which is administered once a week.

According to a report released by Eugene Investment & Securities on the 8th, the global sales of Eli Lilly's obesity injection ‘Zepbound (ingredient name Tirzepatide, domestic product name Maunza)’ and Wegovy are projected to be $35.8 billion (approximately 52.9 trillion won) and $35.6 billion (approximately 51.7 trillion won) respectively by 2025. Zepbound is a drug that will be launched in December 2024, about three and a half years later than Wegovy in the U.S. The average weight loss rate of Zepbound, which is a dual-action drug with GLP-1 and ‘Glucose-dependent Insulinotropic Polypeptide (GIP)’, is about 20%, surpassing Wegovy's 15%, indicating a strong market response.

An industry official involved in obesity drug development stated, “Zepbound, which has a superior efficacy, has surpassed Wegovy, which was the frontrunner in its first year of launch,” and added, “The emergence of the Wegovy Pill will likely put a brake on Zepbound's growth.”

Domestic and foreign latecomers have also jumped into the development of oral obesity drugs. Eli Lilly, for instance, submitted an application for approval for its oral obesity drug pipeline ‘Orforglipron’ to the FDA in December last year. This substance is known to have a single-action mechanism like the Wegovy Pill. Thus, the likelihood of Novo Nordisk and Eli Lilly clashing again in the oral obesity drug market this year has increased.

In contrast, K-pharmaceutical and biotech companies are significantly lagging in the competition for oral obesity drugs. They remain in the early development stages of obesity oral drug candidates (pipelines), such as preclinical or phase 1 clinical trials. Among them, D&D Pharmatech is receiving the most attention.

This company has exported technology for oral GLP-1 or GIP receptor-based obesity drug candidates to its U.S. partner, Metsera, between 2023 and 2024. Included in this was DD02S (Metsera's development name MET-002), which is currently undergoing phase 1 clinical trials in the U.S. for obesity indications. This substance has garnered attention for having over ten times the absorption rate in the body compared to the Wegovy Pill during preclinical stages. Last November, Pfizer's acquisition of Metsera heightened expectations for the success of the obesity drug pipeline.

Additionally, Il Dong Pharmaceutical has successfully completed phase 1 clinical trials for its oral obesity drug candidate ‘ID110521156’, which operates through the GLP-1 mechanism, developed through its subsidiary Unovia. Chung Kun Dang aims to complete the entry into phase 1 clinical trials for its GLP-1 class oral obesity drug candidate ‘CKD-514’ by the second half of this year.

Another industry official in obesity drug development remarked, “It will take at least four more years for the obesity drugs being developed by domestic companies to go through phase 3 trials and reach the approval stage,” and added, “Nevertheless, as the obesity market is rapidly expanding, even capturing just 1% of the market share can be a key factor for performance improvement.”

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