Daewoong Pharmaceutical’s type 2 diabetes treatment has secured product approval in Mexico, a key market in Latin America.
Daewoong Pharmaceutical announced on Wednesday that its type 2 diabetes treatment Envlo 0.3 mg (active ingredient: Inavogliflozin) has received product approval in Mexico.
The company emphasized that this approval is particularly significant as it marks their first product authorization in a major Latin American country. Daewoong Pharmaceutical is actively pursuing a global expansion strategy in international markets. Out of 12 Latin American countries where product approvals were sought, the company has now secured approvals in seven countries, including Mexico, Ecuador, El Salvador, Guatemala, Honduras, the Dominican Republic, and Panama.
Daewoong Pharmaceutical has been steadily expanding its Envlo business collaboration with its local partner Arcera, which boasts a robust distribution network across Latin America. The company has signed Enblo supply contracts with 12 key countries, including Brazil and Mexico, the largest markets in Latin America, and is accelerating its local market penetration efforts.
Daewoong Pharmaceutical explained that this expansion is significant as it effectively captures the major Latin American markets, given that these 12 countries account for over 90% of the region’s total economic scale.
Starting this year, Daewoong Pharmaceutical plans to roll out Envlo launches sequentially across Latin America, ramping up its efforts to nurture a global new drug. According to a report by the International Diabetes Federation (IDF), the number of diabetes patients in Latin America is rapidly increasing due to reduced physical activity from rapid urbanization, a shift towards high-calorie diets centered on ultra-processed foods, and a growing obese population.
Market research firm IQVIA reported that the diabetes treatment market in Latin America reached about 5.5 billion USD as of 2024. Notably, the SGLT-2 inhibitor segment has more than doubled, growing from about 573 million USD in 2022 to approximately 1.23 billion USD in 2024. It has recorded a steep growth rate of nearly 100% over the past two years, gaining attention as a next-generation growth driver.
Envlo is a domestically developed type 2 diabetes treatment in the SGLT-2 inhibitor class, which works by inhibiting glucose reabsorption in the kidneys and excreting it through urine to lower blood sugar levels.
This class is recognized for its excellent blood sugar-lowering effects and safety, as well as therapeutic advantages in kidney disease and heart failure, making it highly competitive in the Latin American market.
Enblo has demonstrated equivalent or superior blood sugar-lowering effects at a low dosage of 0.3 mg, which is about one-thirtieth of existing global pharmaceutical companies’ SGLT-2 inhibitors, based on its high selectivity for the SGLT-2 transporter. It also showed strengths in managing metabolic diseases, such as weight loss and blood pressure improvement.
Generally, SGLT-2 inhibitors are known to have reduced efficacy in patients with declining kidney function. In contrast, Envlo showed significant improvements in diabetic patients with declining kidney function in terms of the urine glucose to creatinine ratio (UGCR), liver fat indicators, and insulin resistance indicators (HOMA-IR).
Positive changes were also observed in albuminuria and cardiac stress indicators (NT-proBNP). The company stated that these results suggest Envlo can provide heart and kidney protection effects from the early stages, beyond just blood sugar control.
Park Seong-soo, Chief Executive Officer (CEO) of Daewoong Pharmaceutical, stated that this approval in Mexico marks the first milestone proving the success of the strategy to expand into the Latin American market alongside our global partners. It will accelerate the local commercialization in Mexico based on its partner’s local network and regulatory expertise, and expand Envlo’s supply throughout Latin America to quickly enhance the influence of our domestic new drug Envlo in the global diabetes market.
