Daewoong Pharmaceutical’s Enblo Receives Product Approval in Indonesia

Indonesia Ranks Fifth Globally in Diabetes Patients
Accelerating the Goal of Entering 30 Countries by 2030

Daewoong Pharmaceutical announced on the 24th that its independently developed new drug for the treatment of type 2 diabetes, Enblo, has received final product approval from Indonesia’s National Agency of Drug and Food Control (BPOM).

New Diabetes Treatment Drug Enblo. Daewoong Pharmaceutical

This approval is significant as it marks the company’s official entry into a key Southeast Asian market. Indonesia is the largest country in Southeast Asia in terms of both population and economic scale and is considered a benchmark nation representing the regional healthcare market.

According to the International Diabetes Federation (IDF), Indonesia had approximately 20.4 million adult diabetes patients as of 2024, ranking fifth in the world. The diabetes treatment market in Indonesia is projected to reach about 380 million dollars (approximately 563.2 billion won) in 2025. Daewoong Pharmaceutical is also preparing to launch Enblo in other major Southeast Asian countries, such as the Philippines and Thailand, where product approvals have already been obtained.

Enblo is the 36th new drug developed in South Korea. In phase 3 clinical trials, a once-daily low dose of 0.3 mg demonstrated a non-inferior blood glucose-lowering effect compared to the existing SGLT-2 inhibitor, dapagliflozin. Notably, clinical studies including Asian patient groups showed a 78.1% achievement rate for glycosylated hemoglobin (HbA1c) targets (compared to 65.7% for dapagliflozin), a reduction in fasting plasma glucose (FPG), and a 60% improvement in insulin resistance. The safety profile was also confirmed, taking into account long-term administration.

SGLT-2 inhibitors are treatments that lower blood glucose by inhibiting the action of the SGLT-2 protein, which is responsible for the reabsorption of glucose and sodium in the kidneys, thereby promoting the excretion of glucose and sodium through urine. In addition to blood glucose control, these drugs are expected to contribute to weight loss and blood pressure reduction. They are also known to have positive effects on overall metabolic health, including the protection of heart and kidney function.

Park Sungsoo, CEO of Daewoong Pharmaceutical, stated, “Enblo’s approval in Indonesia is an important achievement that expands our global presence in major Asian markets and adds momentum to our global strategy of entering 30 countries by 2030. We will continue to strengthen our international regulatory competitiveness by securing ongoing global approvals and provide better treatment options for diabetes patients worldwide.”

This content was produced with the assistance of AI translation services.