Daewoong Pharmaceutical announced on the 21st that it has submitted New Drug Application (NDA) dossiers for 'Envlo,' a new SGLT2 inhibitor class diabetes drug, to three countries: Indonesia, the Philippines, and Thailand.
Daewoong Pharmaceutical plans to accelerate its entry into ASEAN countries starting with the NDA submissions for Envlo in Indonesia, the Philippines, and Thailand. The company also aims to expand further overseas, targeting entry into 15 countries by 2025 and 50 countries by 2030.
According to 2021 global IMS data, the diabetes market size in the ASEAN region totals 1.7 trillion KRW. By country, the market size is 300 billion KRW in Indonesia, 400 billion KRW in Thailand, and 480 billion KRW in the Philippines. In particular, Indonesia is the fourth most populous country in the world and is one of the largest consumers of pharmaceuticals in Asia, according to Daewoong Pharmaceutical.
Daewoong Pharmaceutical plans to minimize the time gap between the domestic launch of Envlo in the first half of this year and its release in major overseas countries. Through this, the company expects to secure the patent duration for as long as possible compared to competing drugs, maximizing the status of Envlo as an original new drug product.
Envlo is a diabetes treatment drug with the SGLT2 (sodium-glucose co-transporter 2) inhibitor mechanism, successfully developed by Daewoong Pharmaceutical in November last year, making it the first domestic pharmaceutical company to achieve this.
Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, "The NDA submissions for Indonesia, the Philippines, and Thailand mark the launch signal for Daewoong Pharmaceutical’s global blockbuster development of domestically synthesized new drugs, following Fexuclue and now Envlo." He added, "Starting with these ASEAN country NDA submissions, we expect that Envlo, the 36th domestically developed new drug, will expand its entry into global markets worldwide."
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