Hanmi Pharmaceutical is expanding the indications for its GLP-1 drug, epeglanatide, to include diabetes treatment. The company views obesity not as a standalone disease but as part of a complex metabolic disorder that includes type 2 diabetes and cardiovascular diseases. To this end, Hanmi is implementing a Life Cycle Management (LCM) strategy to broaden the use of epeglanatide, aiming to develop a 'metabolic disease integrated platform' that connects obesity, diabetes, and cardiovascular conditions.
On May 18, Hanmi announced that it has begun dosing participants in a Phase 3 clinical trial in South Korea to expand the drug's indications for diabetes treatment. The trial evaluates the blood sugar control effects of a combination therapy involving epeglanatide, metformin, and SGLT2 inhibitor dapagliflozin in patients with type 2 diabetes, with the first doses administered last month.
The Phase 3 trial is being conducted as a multicenter, randomized, double-blind, placebo-controlled study involving domestic patients. The trial is expected to conclude in 2028.
Hanmi plans to secure diabetes indications based on its global development experience involving 6,000 type 2 diabetes patients in collaboration with its partners.
According to the company, epeglanatide not only shows weight loss and blood sugar control effects but also has potential cardiovascular and kidney protective benefits.
Kim Na-young, head of Hanmi's Innovation Growth Division, stated, "Epeglanatide has the potential to expand its treatment area beyond obesity to various metabolic diseases, including diabetes and cardiovascular and kidney diseases."
Meanwhile, Hanmi submitted a product approval application for its obesity drug epeglanatide to the Ministry of Food and Drug Safety in December last year. It has been designated for the Global Innovative Fast Track (GIFT) program, which is expected to shorten the review period compared to standard approval processes.
The company emphasizes that epeglanatide has been directly tested for efficacy and safety in Koreans, unlike major global products such as 'Wegovy,' and aims to enter not only the domestic market but also the global market, including Asia.
The global obesity treatment market is experiencing rapid growth. 'Mounjaro' generated $8.7 billion in sales in the first quarter of this year, surpassing cancer drug 'Keytruda' to become the world's best-selling drug. During the same period, 'Wegovy' recorded sales of 18.235 billion kroner (approximately $4 billion), solidifying the position of obesity and diabetes new drugs as key growth drivers in the global pharmaceutical market.
On May 18, Hanmi announced that it has begun dosing participants in a Phase 3 clinical trial in South Korea to expand the drug's indications for diabetes treatment. The trial evaluates the blood sugar control effects of a combination therapy involving epeglanatide, metformin, and SGLT2 inhibitor dapagliflozin in patients with type 2 diabetes, with the first doses administered last month.
The Phase 3 trial is being conducted as a multicenter, randomized, double-blind, placebo-controlled study involving domestic patients. The trial is expected to conclude in 2028.
Hanmi plans to secure diabetes indications based on its global development experience involving 6,000 type 2 diabetes patients in collaboration with its partners.
According to the company, epeglanatide not only shows weight loss and blood sugar control effects but also has potential cardiovascular and kidney protective benefits.
Kim Na-young, head of Hanmi's Innovation Growth Division, stated, "Epeglanatide has the potential to expand its treatment area beyond obesity to various metabolic diseases, including diabetes and cardiovascular and kidney diseases."
Meanwhile, Hanmi submitted a product approval application for its obesity drug epeglanatide to the Ministry of Food and Drug Safety in December last year. It has been designated for the Global Innovative Fast Track (GIFT) program, which is expected to shorten the review period compared to standard approval processes.
The company emphasizes that epeglanatide has been directly tested for efficacy and safety in Koreans, unlike major global products such as 'Wegovy,' and aims to enter not only the domestic market but also the global market, including Asia.
The global obesity treatment market is experiencing rapid growth. 'Mounjaro' generated $8.7 billion in sales in the first quarter of this year, surpassing cancer drug 'Keytruda' to become the world's best-selling drug. During the same period, 'Wegovy' recorded sales of 18.235 billion kroner (approximately $4 billion), solidifying the position of obesity and diabetes new drugs as key growth drivers in the global pharmaceutical market.
* This article has been translated by AI.
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