Korea approves Daewoong Pharmaceutical's diabetes drug

DAEWOONG PHARMACEUTICAL has received domestic approval for its diabetes drug Envlo with the active ingredient enavogliflozin, the second straight year for the company to release a self-developed medication following last year's Fexuclue, which treats gastroesophageal reflux with the active ingredient Fexuprazan.

The company on Thursday said the Ministry of Food and Drug Safety approved the day before the 0.3-mg tablet of Envlo, a diabetes drug with a sodium-glucose cotransporter 2 (SGLT2) inhibitor mechanism.

Envlo has three forms of therapy: monotherapy, combination therapy with metformin, and combination therapy with metformin and gemigliptin.

Daewoong Pharmaceutical said the global market for diabetes treatment using SGLT2 inhibitors last year was worth about 27 trillion won ($20.7 billion), with the Korean market alone valued at 150 billion won. The company could thus gain a major presence on the global market for Type 2 diabetes treatment, which is worth about 93 trillion won.

Citing Envlo's approval, Daewoong Pharmaceutical said it is Korea's first company to develop a new diabetes drug. It plans to enter the global market for SGLT2 inhibitor-based medications, a sector whose R&D and approved medications have been dominated by multinational pharmaceutical giants.

Envlo's release in Korea is scheduled for the first half of next year after reimbursement and drug pricing procedures are conducted, with reimbursement registration eyed for the first half of 2023. The company is also prepping to enter 10 major export markets by 2025 including China, Brazil and Saudi Arabia and 50 by 2030 with a sales goal of a combined 100 billion won over three years.

Daewoong Pharmaceutical said Envlo will offer a new treatment option for patients whose bodies cannot properly regulate blood sugar levels.

CEO Lee Chang-jae said, "The independent development of Korea's first drug using an SGLT2 inhibitor, the most notable diabetes treatment on the global market, is a significant achievement," adding, "We will seek to raise the quality of life of diabetic patients at home and abroad by providing the best new diabetes drugs to them." 

Write to Jung-Eun Kim at likesmile@hankyung.com