Daewoong 바카라 사이트 추천디시 secures Indonesian marketing approval for diabetes drug ‘Envlo’, marking full-scale entry into Southeast Asia

[by Kang, In Hyo] Daewoong Pharmaceutical announced on December 24 that its in-house-developed treatment for type 2 diabetes, ‘Envlo (enavogliflozin),’ has received final product approval from Indonesia’s drug regulatory authority, the National Agency of Drug and Food Control (BPOM).

The approval is significant as it represents a full-scale entry into a key Southeast Asian market. Indonesia, the most populous and economically dynamic country in Southeast Asia, is widely regarded as a benchmark market for regional healthcare. As such, it is a strategic priority for global 바카라 사이트 추천디시 companies seeking to expand in Southeast Asia, and this milestone further strengthens Daewoong 바카라 사이트 추천디시's foundation for broader business expansion across the region.

According to the International Diabetes Federation (IDF), Indonesia recorded approximately 20.4 million adults living with diabetes last year, ranking fifth worldwide. The country’s diabetes treatment market is projected to reach around USD 380 million (approximately KRW 510 billion) this year.

The company noted that approval of Envlo is meaningful in that it expands treatment options for Indonesian patients, given the country’s large diabetes population and the significant number of patients who remain inadequately controlled on existing therapies. Daewoong Pharmaceutical is also preparing to roll out the product in other major Southeast Asian markets, including the Philippines and Thailand, where regulatory approval has already been secured.

The regulatory track record accumulated by Envlo in multiple jurisdictions is expected to serve as a positive reference for future approvals in other key markets. As Daewoong 바카라 사이트 추천디시 accelerates global commercialization, having recently secured export bases in 10 additional Latin American countries, this Indonesian approval is expected to be a significant step forward for Envlo's global market entry.

Envlo is Korea's 36th domestically developed novel drug. In Phase 3 clinical trials, it demonstrated non-inferior glycemic control compared with the established SGLT-2 inhibitor dapagliflozin at a low, once-daily dose of 0.3 mg. Daewoong 바카라 사이트 추천디시 highlighted that clinical trials, particularly those involving Asian patient populations, showed a higher HbA1c target achievement rate of 78.1% (compared to 65.7% for dapagliflozin), alongside reductions in fasting plasma glucose (FPG) and a 60% improvement in insulin resistance. The company further emphasized that a favorable safety profile was confirmed, even under conditions of long-term use.

Sodium–glucose cotransporter-2 (SGLT-2) inhibitors are antidiabetic agents that reduce blood glucose levels by blocking the activity of SGLT-2, a renal transport protein responsible for reabsorbing glucose and sodium in the kidneys, thereby promoting urinary excretion of glucose and sodium. In addition to improving glycemic control, this mechanism promotes weight loss and reduces blood pressure. It also has a positive impact on overall metabolism and protects cardiovascular and renal function.

“Envlo’s approval in Indonesia represents a meaningful milestone that strengthens our presence in major Asian markets and further accelerates the momentum of our global strategy to enter 30 countries by 2030,” said Park Seong-soo, CEO of Daewoong Pharmaceutical. “We will continue to pursue regulatory approvals worldwide to enhance our international regulatory competitiveness and to deliver improved treatment options for diabetes patients around the world,” he added.