Daewoong Pharmaceutical's Envlo to enter the global market in full swing with filing for product license in three ASEAN countries

• Submitted an NDA to Indonesia, Philippines and Thailand
• Signed the export contract in Brazil and Mexico in last February
• Aiming to enter 50 countries by 2030

SEOUL, South Korea, March 22, 2023 /PRNewswire/ -- Daewoong Pharmaceutical began the advance into the global market in full swing with their national new diabetes drug, Envlo (ingredient: enavogliflozin).

Daewoong Pharmaceutical (CEO Seng-ho Jeon and Lee Chang-jae) recently revealed that they submitted a new drug application (NDA) in Indonesia, Philippines and Thailand, the largest markets in Southeast Asia for Envlo, the SGLT2 enzyme inhibitor type new drug for diabetes. 

Daewoong Pharmaceutical plans to accelerate the advance into the ASEAN countries, starting with the submission of NDA for Envlo in Indonesia, Philippines and Thailand. They also plan to spur the entry into other countries such as China, Saudi Arabia and Russia to penetrate 15 countries by 2025 and 50 countries by 2030, growing it into the nation's Best-in-class drug.

According to data from Global IMS in 2021, the size of the diabetes market in ASEAN countries is USD 1.3 billion, specifically with Indonesia accounting for USD 226 million, Thailand USD 308 million and Philippines USD 365 million. ASEAN countries are growing steadily every year, gaining attention as an emerging market in the global pharmaceutical and bio industry, and in particular, Indonesia has the fourth most population in the world and is one of the countries that most consume medications in Asia.

‌Daewoong Pharmaceutical plans to minimize the gap between the time of release in major countries after the launch in the first half of this year in Korea. They expect that it will bring a longer patent duration than other rival drugs in the countries, maximizing the position as the original new drug in the countries.

Last month, Daewoong Pharmaceutical signed a USD 84.36 million export contract with Brazil and Mexico. The size of diabetes market of Brazil and Mexico is approximately USD 1.54 billion, accounting for 70% of the entire diabetes market in Central and South America. The local partner is M8 Pharmaceuticals (CEO Joel Barlan), and Envlo is aimed to be released in the second half of 2024 by moving quickly with local licensing procedures.

Envlo is the nation's first sodium glucose cotransporter 2 (SGLT2) inhibitor for diabetic treatment developed last November by Daewoong Pharmaceutical. It has been proven to show equal medicinal effect with only 0.3mg which is 1/30 of the amount of existing SGLT2 inhibitor and outstanding glycated hemoglobin (HbA1c) and fasting blood sugar reduction effects compared to the existing drugs in the market through phase 3 clinical trials on type 2 diabetic patients, as well as safety. In addition, the proportion of patients with a glycated hemoglobin reduction of more than 0.5% compared to before treatment also recorded up to 82.9%, compared to the 40-60% level of drugs in the same class.

Envlo, which showed effects on weight loss, blood pressure reduction, lipid profile improvement, and insulin resistance improvement, as well as excellent blood sugar lowering and proteinuria improvement effects compared to the same class of drugs in type 2 diabetic patients with reduced renal function, is expected to be a new treatment option for patients with insufficient blood sugar control. Currently, there are three indications secured: - monotherapy - metformin combination therapy - metformin and gemigliptin combination therapy.

CEO Seng-ho Jeon from Daewoong Pharmaceutical stated, "The recent product license application in Indonesia, Philippines and Thailand for Envlo following Fexuclue is astonishing achievement for our move to grow the domestic synthetic new drug into a global blockbuster", adding "With the product license application in the ASEAN countries as a starting point, we expect that Envlo will expand its entry into the global market in future."

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