New Type 2 Diabetes Drug 'Enblojeong' Approved by MFDS
SGLT-2 Inhibitor Mechanism... Market Launch Targeted for Next Year
Daewoong Pharmaceutical's diabetes treatment 'Enblo (active ingredient: Inavogliflozin)' logo (Photo by Daewoong Pharmaceutical)
[Asia Economy Reporter Lee Chun-hee] Daewoong Pharmaceutical announced on the 1st that its new drug for type 2 diabetes, "Enblo Tablets 0.3 mg (active ingredient: Inavogliflozin)," received approval from the Ministry of Food and Drug Safety on the 30th of last month.
With this, Daewoong Pharmaceutical has succeeded in obtaining approval for a new drug for two consecutive years, following last year's 34th domestic new drug, the gastroesophageal reflux disease treatment "Pexuclu," and this year's 36th new drug, Enblo.
Diabetes is classified into type 1 diabetes, in which immune cells attack and destroy pancreatic beta (β) cells due to genetic factors, resulting in insufficient insulin production, and type 2 diabetes, generally considered an "adult disease," which occurs in adults over 40 years old due to factors such as obesity and aging that reduce insulin secretion.
Enblo Tablets were developed as an adjunct to diet and exercise therapy essential for improving blood glucose control in type 2 diabetes patients. It selectively inhibits the sodium-glucose co-transporter (SGLT)-2 involved in glucose reabsorption in the kidneys, blocking the reabsorption of glucose into the bloodstream and promoting its excretion in urine, thereby lowering blood glucose levels.
SGLT-2 inhibitors are estimated to have a global market size of approximately 27 trillion KRW and a domestic market size of about 150 billion KRW as of last year. It is analyzed that they are rapidly replacing the global type 2 diabetes market, which amounts to over 93 trillion KRW. Last year, the Korean Diabetes Association also prioritized recommending treatments including SGLT-2 inhibitors, which have proven cardiovascular benefits for diabetic patients with heart failure.
In the previously disclosed phase 3 clinical trial of Enblo, Daewoong Pharmaceutical conducted a 24-week administration on a total of 160 type 2 diabetes patients. The treatment group showed about a 1 percentage point reduction in glycated hemoglobin (HbA1c) compared to the placebo group, with statistical significance achieved. Furthermore, significant improvements were confirmed in indicators such as body weight, blood pressure, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared to placebo.
Additionally, in combination therapies with two drugs including metformin and three drugs including metformin and gemigliptin, non-inferiority was demonstrated in HbA1c change rates compared to the active comparator dapagliflozin. Accordingly, the approved indications now include monotherapy as well as two-drug and three-drug combination therapies. Daewoong Pharmaceutical stated, "Notably, we proved equivalent efficacy with only 0.3 mg, which is less than one-thirtieth of existing SGLT-2 inhibitors," adding, "This will provide a new treatment option for patients with insufficient blood glucose control."
For domestic market launch, Daewoong Pharmaceutical plans to immediately proceed with reimbursement and pricing procedures for Enblo Tablets and aims to have all three indications listed for reimbursement by the first half of next year. Global expansion is also underway, with plans to enter about 10 major countries including China, Brazil, and Saudi Arabia by 2025, and approximately 50 countries worldwide by 2030.
Moreover, clinical trials for additional indications and development of combination drugs with various ingredients are in progress. Currently, clinical trials for a metformin combination drug are underway, with the goal of completing them soon and launching the product in the market by the second half of next year. Through this, they have set a target of achieving cumulative sales of 100 billion KRW over three years.
Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, "It is highly significant that we developed Enblo Tablets, an SGLT-2 inhibitor, which is one of the most notable diabetes treatments globally, using domestic technology for the first time in Korea," adding, "The significant reduction in clinical trial duration compared to competitors is also noteworthy." He continued, "We will strive to improve the quality of life for diabetic patients domestically and internationally by providing the best-in-class new diabetes drug," and "We will continuously strengthen our new drug development capabilities and global business to steadily contribute to the advancement of the domestic pharmaceutical industry."
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