(Health Korea News / Lee Chung-man) GeneOne Science has thrown down the gauntlet in the market for a triple-drug diabetes combination drug consisting of dapagliflozin, sitagliptin, and metformin.
Today (the 23rd), GeneOne Science received product approval from the Ministry of Food and Drug Safety for two dosage forms (5/50/1000mg, 10/100/1000mg) of ‘Positaem extended-release tablets’ (ingredient name: dapagliflozin + sitagliptin + metformin) as a prescription drug.
The target indication is to administer it as an adjunct to diet and exercise therapy to improve glycemic control in patients with type 2 diabetes who are suitable for combination therapy with dapagliflozin, sitagliptin, and metformin.
These ingredients treat diabetes through different mechanisms and effects.
① Dapagliflozin is an SGLT-2 inhibitor. It works by selectively inhibiting SGLT-2, which is involved in the reabsorption of glucose in the kidneys (renal tubules), thereby blocking the reabsorption of glucose excreted in urine into the bloodstream. The original drug is AstraZeneca’s ‘Forxiga’.
②Sitagliptin inhibits the DPP-4 enzyme, thereby preventing the decomposition of GLP-1, an insulin-secreting hormone, and inducing insulin production. MSD’s DPP-4 inhibitor ‘Januvia’ is the original drug.
③Metformin improves insulin sensitivity by preventing glucose production in the liver and reducing glucose absorption in the intestines.
Therefore, it is expected that ‘Positaem Serum Tablets’ will be able to manage diabetes more effectively by controlling blood sugar levels through different mechanisms.
The reason why ‘Positaem Extended-release Tablet’ was designed as an extended-release formulation is interpreted as a combination drug that combines different drugs. Extended-release formulations can minimize drug interactions by allowing each drug component to be released slowly without interfering with each other’s absorption and metabolism.
①+②+③ This is not the first time that a combination drug has received approval, as is Genewon Science’s ‘Positaem Extended-Rang Tablet’. In May 2023, Hanmi Pharmaceutical received approval from the Ministry of Food and Drug Safety for three doses (5/50/500mg, 5/50/750mg, 5/50/1000mg) of ‘Sildapaem Extended-Rang Tablet’ (ingredient name: dapagliflozin + sitagliptin + metformin).
Then, in June 2023, one month later, Daewon Pharmaceutical received approval from the Ministry of Food and Drug Safety for three dosages (5/50/500mg, 5/50/750mg, 5/50/1000mg) of ‘Dapagliflozin Extended-Range Tablet’ (ingredient name: dapagliflozin + sitagliptin + metformin).
Hanmi Pharmaceutical’s ‘Sildapaem Extended-Rang Tablet’ and Daewon Pharmaceutical’s ‘Dapasitaem Extended-Rang Tablet’ have shown strong sales since their launch in September 2023, demonstrating the growth potential of the ①+②+③ triple combination tablet market. According to U-BIST, ‘Sildapaem Extended-Rang Tablet’ and ‘Dapasitaem Extended-Rang Tablet’ recorded sales of approximately KRW 200 million over three months in 2023.
This is presumed to be the reason why Genewon Science entered the ①+②+③ combination market competition. However, as a latecomer, Genewon Science is attempting to differentiate itself by varying the dosage of the combination ingredients, unlike Hanmi Pharmaceutical or Daewon Pharmaceutical.
The dosages of ‘Sildapaem SR-T’ and ‘Dapasitaem SR-T’ are fixed at ①5mg and ②50mg, while the dosage of ③ has been made flexible at 500mg, 750mg, and 1000mg. This is because ① and ② are effective at relatively fixed dosages, but the side effects of ③ can vary from patient to patient depending on the dosage.
On the other hand, Genewon Science’s ‘Positaem SR tablet’ fixed the dosages of ① and ③ to 5 mg and 1000 mg, respectively, and subdivided the dosage of ② to 50 mg or 100 mg. It seems that they wanted to emphasize the differentiation of the product compared to ‘Sildapaem SR tablet’ and ‘Dapasitaem SR tablet’ by fixing the dosage of ③ to the maximum and designing the dosage of ② to be flexible.
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