The 36th Korean new drug has come out. ‘Envlo tablet (active ingredient: enavogliflozin)’, Daewoong Pharmaceutical’s new drug for diabetes mellitus obtained domestic approval on November 30th.
Envlo tablet is a diabetes drug based on a mechanism of inhibiting SGLT2 (sodium glucose cotransporter 2). It has three indications: monotherapy, metformin combination therapy, and metformin/gemigliptin combination therapy.
SGLT2 inhibitor diabetes drugs, which are rapidly replacing existing drugs in the global type 2 diabetes market worth 93 trillion won, have a market size of 27 trillion won globally and 150 billion won domestically as of 2021.
In the field of SGLT2 inhibitors, which have been thus far developed and licensed mainly by multinational pharmaceutical companies, Daewoong Pharmaceutical has become the first company in Korea to develop a new diabetes drug with this mechanism successfully upon the occasion of the product approval for Envlo tablet.
For the launch in the domestic market, Daewoong Pharmaceutical plans to proceed with the health insurance and drug price related procedures for Envlo tablet immediately, and list all monotherapy, metformin combination therapy, and metformin and gemigliptin combination therapy in the first half of 2023.
At the same time, the company also prepared for entry into the global market, establishing a roadmap to enter 10 major countries including China, Brazil, and Saudi Arabia by 2025 and over 50 countries around the world by 2030.
Daewoong Pharmaceutical plans to complete the clinical trials of the metformin combination therapy as soon as possible while conducting clinical trials to secure additional indications and developing combination therapies with various ingredients. Through this, it plans to achieve cumulative sales of 100 billion won over three years.
Mr. Lee Chang-Jae, CEO of Daewoong Pharmaceutical, said, “It is very significant that we developed the SGLT2 inhibitor Envlo tablet, which is the most notable diabetes treatment in the global market, for the first time in Korea with our own technology. It is also noteworthy that the time spent on clinical trials was significantly shortened compared to competitors.”
[WIKI KOREA=Cho Pil Hyun, Staff Reporter]
chop23@wikileaks-kr.org