Daewoong applies for approval of Envlo in Saudi Arabia

South Korea's Daewoong Pharmaceutical Co. announced on Friday that it has submitted an application for regulatory approval of its new diabetes treatment drug Envlo tablet (active ingredient: enavogliflozin) to the Saudi Food and Drug Authority (SFDA).

Envlo is a diabetes treatment medication developed by Daewoong Pharmaceutical using the mechanism of SGLT-2 (sodium-glucose co-transporter 2) inhibition, making it the first of its kind developed by a domestic drug company. It was officially launched in the South Korean market in May this year.

Daewoong has completed the submission of the approval application for the same drug in four ASEAN countries. With the initiation of the regulatory submission process in Saudi Arabia, the company aims to accelerate its global expansion.

According to IQVIA, a pharmaceutical market research organization, as of last year, the diabetes treatment drug market in Saudi Arabia reached $919 million, making it the largest in the Middle East. The SGLT-2 inhibitor market segment, which includes Envlo, has grown to a size of $116 million, more than doubling in the past two years.

"Using Saudi Arabia as a stepping stone for entering the Middle East market, we will do our best to ensure that our domestically developed new drug, Envlo, can grow into a global blockbuster," CEO of Daewoong Pharmaceutical Jeon Seng-ho said. 

Write to Ji-Hyun Lee at bluesky@hankyung.com