As obesity drugs have been found not only to reduce weight but also to slow the progression of metabolic and cardiovascular diseases such as diabetes and heart disease, the global market is growing rapidly. With U.S.-based Eli Lilly and Denmark's Novo Nordisk forming a two-horse race in the global market, new obesity drug candidates under development in Korea are drawing market attention.
Domestic corporations are developing new drugs that add novel targets to existing obesity medications to reduce side effects, while extending the duration of action to cut dosing frequency and improve patient convenience. Development is also underway to convert injectables into oral formulations. Domestic corporations are targeting not only the domestic market but also overseas markets through technology exports.
◇ Hanmi Pharmaceutical, strategy to enter the global market with performance as a national obesity drug
Hanmi Pharmaceutical is the leading domestic company in obesity drug development. It recently drew attention by announcing phase 3 trial results confirming the safety and weight-loss efficacy of the glucagon-like peptide (GLP)-1 class obesity drug candidate "efpeglenatide."
Hanmi Pharmaceutical's phase 3 trial was conducted at domestic university hospitals with adult obese patients without diabetes. According to the company, at week 40 of dosing, the average weight loss rate was 9.75%. Some patients showed a reduction rate reaching 30% at week 40. Based on these phase 3 results, Hanmi Pharmaceutical plans to apply for domestic product approval within the year and aims to launch around the end of next year.
If Hanmi Pharmaceutical's obesity drug succeeds, it would mark the first appearance of a Korea-made new drug in a domestic market dominated by global drugmakers, but there is a limitation in that the trial was confined to Korea, potentially restricting it to domestic use.
Global clinical trials are more complex and entail far greater expense than domestic trials. Trial designs must account for race, and recruiting hospitals and patients is no easy task. This is why domestic corporations seek to pursue global trials through technology transfer.
Hanmi Pharmaceutical is seen as aiming to first succeed with efpeglenatide as a "national obesity drug" in Korea, then invest the revenue in developing five other obesity drug candidates to boost the potential for global technology exports. According to the company, the drug was more effective in women with a body mass index (BMI, weight (kg) divided by height squared (m²)) of 30 or lower. This suggests it could be an obesity drug suited to Koreans, among whom extreme obesity is less common.
◇ Ildong Pharmaceutical·D&D Pharmatech show results in oral obesity drugs
Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, currently sold on the market, are both subcutaneous injections that patients administer by inserting the needle into the skin themselves, with weekly dosing required. This causes inconvenience for patients and a heavy cost burden. A one-month supply of the lowest dose costs in the 200,000-won range, while the highest dose is around 400,000 to 500,000 won. Because of these issues, patients arbitrarily discontinuing treatment or dosing irregularly has been cited as a major limitation.
Domestic corporations are seeking differentiation by overcoming the limits of existing obesity drugs. Unovia, a research and development (R&D) subsidiary of Ildong Pharmaceutical, and D&D Pharmatech, founded by Sungkyunkwan University College of Pharmacy distinguished professor Lee Kang-chun and his son, Johns Hopkins University School of Medicine professor Lee Seul-gi, are developing oral obesity drug candidates.
On the 29th, Ildong Pharmaceutical announced at an investor relations (IR) session the results of a phase 1 trial of its in-house oral GLP-1 class obesity drug candidate "ID110521156." In a domestic trial with 36 adults taking a once-daily dose, the high-dose (200 mg) group recorded an average 9.9% (8.8 kg) weight loss after four weeks.
This figure outperformed the weight-loss data confirmed in trials for Eli Lilly's oral obesity drug in development "orforglipron" and Swiss Roche's oral obesity drug candidate "RG6652." Orforglipron showed a 6.4% reduction in the high-dose group at week 4, while Roche's RG6652 posted 7.3%.
Ildong Pharmaceutical said it plans to conduct a phase 2 trial in the United States next year. Lee Jae-joon, Ildong Pharmaceutical's chief operating officer (COO) and Unovia CEO, said, "ID110521156 is superior in manufacturing efficiency, cost-effectiveness, and user convenience compared with existing peptide injectables," adding, "The production cost is also far lower, which will favor commercialization."
On the 31st, D&D Pharmatech's share price hit a record high. The rise followed reports that Novo Nordisk, after Pfizer, had made an acquisition offer for U.S. obesity drug developer Metsera. In 2023 and last year, D&D Pharmatech transferred six obesity drug candidates, including the oral GLP-1 class "DD02S," to Metsera in deals worth about 1.1 trillion won.
The company will also unveil, for the first time on the 6th, preclinical results for the oral obesity drug candidate "MET-GGo." This candidate is a dual agonist that acts on gastric inhibitory polypeptide (GIP) along with GLP-1. GIP breaks down fat cells and reduces nausea, the company said. Lee Seul-gi, CEO of D&D Pharmatech, said, "As Metsera's first oral obesity therapy, MET-GGo is expected to draw strong market interest."
◇ Corporations with long-acting technologies also in focus
Other corporations are taking on the challenge with differentiated technologies. G2GBIO is developing an obesity treatment platform that can be dosed once a month, with plans to enter clinical trials next year. The company has a platform called "Inno.LAMP" that prolongs drug efficacy.
Simply put, Inno.LAMP is a technology that encapsulates a drug in small, round microparticles so it is released slowly in the body. This allows for longer intervals between injections. Leveraging this technology, the company is attempting to convert existing weekly-dosed obesity drugs into once-monthly or three-times-monthly dosing regimens.
According to G2GBIO, development of a one-month formulation of semaglutide, the active ingredient in Wegovy, has been completed, with entry into clinical trials targeted for the first half of next year. A three-month formulation is also under development. The company has research collaboration agreements to co-develop long-acting injectables with four global big pharma companies, including C. H. Boehringer Sohn AG & Co. KG, and is developing new drug candidates not only for obesity but also for schizophrenia and dementia.
Peptron also signed a technology evaluation agreement with Eli Lilly last year for long-acting formulation technology and is conducting joint research. The market is watching to see whether this will lead to a definitive technology transfer contract.