• Delivers new drug for two consecutive years by obtaining product license on "Envlo", Korea's 36^th new drug from the Ministry of Food and Drug Safety
• Plans to enter the type 2 diabetes global market worth $71.4 billion
• Provides new and broad treatment options for patients with insufficient blood glucose control with three indications

SEOUL, South Korea, Dec. 6, 2022 /PRNewswire/ -- Daewoong Pharmaceutical (CEO Jeon Sengho, Lee Changjae), a global healthcare company, announced on 5^th that its "Envlo 0.3mg", a new sodium-glucose cotransporters 2 inhibitor (SGLT2) developed to treat type 2 diabetes mellitus obtained a product license from the Ministry of Food and Drug Safety on November 30. Envlo is indicated for monotherapy, combination therapy with Metformin and combination therapy with Metformin and Gemigliptin.

SGLT2 inhibitors, which are rapidly replacing the global type 2 diabetes market worth $71.4 billion, are known to account for about $20.7 billion globally and $100 million in Korea as of 2021.

Until now, the development and approval of SGLT2 inhibitors have been carried out mainly by multinational pharmaceutical companies. Daewoong Pharmaceutical, South Korea's leading healthcare company, became the first domestically to succeed in developing a new antidiabetic drug in this class by obtaining a product license. Daewoong Pharmaceutical plans to actively pursue the global market through this product.

Daewoong Pharmaceutical plans to move quickly with the procedures concerning Envlo's insurance coverage and price in order to register the drug in National Health Insurance System with an indication of monotherapy, combination therapy with Metformin or Metformin & Gemigliptin in the first half of 2023. At the same time, the company has developed a roadmap to enter the global market over 10 countries including China, Brazil and Saudi Arabia by 2025 and 50 countries by 2030. The company is also running clinical trials for indication expansion while developing combination drugs. Daewoong Pharmaceutical aims to deliver the metformin combination drug in the second half of 2023, by accelerating the trial. The company estimates to achieve a cumulative three-year sale of 100 billion Korean Won.

Earlier in October, Daewoong Pharmaceutical announced the Phase 3 study results of Envlo in patients with type 2 diabetes which have shown excellent hypoglycemic effect and the safety. In particular, Envlo has demonstrated its equivalent efficacy with 0.3 mg, which is less than one-thirtieth dosage of existing SGLT2 inhibitors. Its indication is also expected to provide a new treatment option for patients with insufficient blood sugar control.

An official from Daewoong Pharmaceutical said, "While SGLT2 inhibitors are drawing the most attention in the global market, it is meaningful that we are the first company in Korea to develop the new diabetes medication in this class." The company official also added, "We will make our best effort to improve the quality of life of patients by providing the best-in-class antidiabetic drug. We will also contribute to the development of global pharmaceutical industry by continuously strengthening new drug development and global business through open collaboration with various partners."

Meanwhile, Envlo, approved as the 36th new drug in Korea following the 34th new drug "Fexuclue" last year, listed its name as a first domestic drug to be designated for an accelerated approval by the Ministry of Food and Drug Safety in 2020.