Daewoong Pharmaceutical submits a new drug application (NDA) for Enavogliflozin in Mexico

Daewoong Pharmaceutical submits a new drug application (NDA) for Enavogliflozin in Mexico - Aims to enter Mexican diabetes treatment market worth USD 1.5 billion, Enavogliflozin planned to be released in 2025 Daewoong Pharmaceutical has begun a full-fledged push into the global market with its novel drug, Enavogliflozin, a treatment for type 2 diabetes. Daewoong Pharmaceutical (CEO Seongsoo Park, Chang-jae Lee) announced the submission of a New Drug Application (NDA) for their Enavogliflozin to the COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico. According to data from Mordor Intelligence™, the Mexican market for type 2 diabetes treatment is currently valued at USD 1.5 billion and is projected to reach USD 2 billion by 2029. Last year, Daewoong Pharmaceutical secured a License and Distribution Agreement for Enavogliflozin with M8, a leading pharmaceutical company in Mexico. Daewoong Pharmaceutical anticipates receiving New Drug Approval for Enavogliflozin in Mexico by 2025. Seongsoo Park, CEO of Daewoong Pharmaceutical, stated, “With SGLT-2 inhibitors rapidly gaining traction in the global market, our submission of Enavogliflozin for product approval in Mexico marks a significant milestone. We hope that Enavogliflozin, Korea’s first novel SGLT2 inhibitor, will not only expand in Mexico but also into other Latin American markets, including Brazil.” SGLT-2 inhibitors are experiencing significant growth in the global diabetes treatment market. A report by Mordor Intelligence™ estimates that the market will be valued at USD 11.42 billion in 2024 and is expected to rise to USD 17.32 billion by 2029, reflecting a compound annual growth rate (CAGR) of 8.68% from 2024 to 2029. Enavogliflozin, administered at just 0.3mg—which is 1/30th the dosage of existing SGLT2 inhibitors—has proven equally or more effective in reducing glycated hemoglobin (HbA1c) and fasting blood glucose levels compared to current market drugs. These results are supported by phase 3 clinical trials involving patients with type 2 diabetes, confirming Enavogliflozin’s favorable safety profile. Forward-Looking Statements This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical’s business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

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