[관련기사 = 대웅제약, 국내 첫 SGLT-2 억제제 신약 '엔블로정' 출시 동시에 보험급여 적용]

Daewoong Pharmaceutical has succeeded in localizing a SGLT-2 inhibitor drug for the treatment of diabetes, becoming the first domestic pharmaceutical company to do so. 

The company announced on May 1 that its new drug, Envlo, has been approved for insurance coverage and will be officially launched in Korea. 

Envlo is available in a 0.3mg dose (ingredient name: enavogliflozin) and has been approved for three indications: monotherapy, combination therapy with metformin, and combination therapy with metformin and gemigliptin. Envlo is a member of the SGLT-2 inhibitor drug class, which helps lower blood sugar levels by inhibiting the sodium-glucose cotransporter 2. 

The drug has demonstrated comparable efficacy to other SGLT-2 inhibitors with a much lower dose, proving its excellent blood glucose-lowering effects and safety. 

Envlo's 0.3mg dose has shown to reduce glycated hemoglobin by approximately 1% compared to placebo, achieve a high target blood glucose level of less than 7% in approximately 70% of patients, and improve cardiovascular risk factors such as weight, blood pressure, and lipids.

In a highly competitive diabetes treatment market, Envlo is expected to become the next blockbuster domestic drug, drawing attention for its low dose and superior efficacy. 

As the first domestic SGLT-2 inhibitor, Envlo represents a significant milestone for Daewoong Pharmaceutical and the Korean pharmaceutical industry, as it is expected to contribute to the advancement of diabetes research and treatment globally.

SGLT-2 inhibitor drugs for the treatment of diabetes are not only known for their blood glucose-lowering effects, but also for their benefits in preventing cardiovascular and renal diseases, promoting weight loss, and lowering blood pressure. 

Globally, these drugs are considered the next-generation diabetes treatment, and Daewoong Pharmaceutical has taken notice of this paradigm shift in the diabetes treatment market. As the first domestic pharmaceutical company to succeed in localizing a SGLT-2 inhibitor drug, Daewoong Pharmaceutical is leading the way in this field.

Unlike conventional diabetes treatments that stimulate insulin secretion or inhibit insulin breakdown, SGLT-2 inhibitors work by excreting glucose in the urine, making them effective when combined with other medications. 

Through large-scale long-term studies, these drugs have been shown to improve cardiovascular health by reducing the risk of cardiovascular diseases or mortality. 

They have also been shown to reduce hospitalizations due to heart failure and protect kidney function. As such, they are valuable for treating diabetes, metabolic disorders, heart failure, and kidney disease all at once. 

Based on the differentiated strengths and marketability of SGLT-2 inhibitors, Daewoong Pharmaceutical has developed its own domestic diabetes treatment and plans to promote it not only in the domestic diabetes market, but also through aggressive global expansion, aiming to become the best-in-class product in this drug class.

Daewoong Pharmaceutical plans to actively promote the unique features of its self-developed Envlo drug to domestic medical professionals. In addition to hosting a two-month-long relay symposium every week following the product launch, the company plans to provide information on the drug's excellent efficacy and effects through various channels such as attending international endocrinology conferences and society events.

Daewoong Pharmaceutical also plans to quickly release Envlo in the global market. 

Prior to its launch in Korea earlier this year, the company entered the diabetes markets of Brazil and Mexico, both worth a total of 2 trillion won. Through a export contract with its local partner M8 (Moksh8, CEO Joel Barlan), the company plans to target 70% of the diabetes market in these two countries, which accounts for the entire diabetes market in Central and South America. 

The contract is worth 108.2 billion won, including technology transfer fees, and aims to obtain local approval quickly and release the drug in the second half of next year. 

Additionally, as a first step towards entering the ASEAN market worth a total of 170 billion won based on 2021 Global IMS data, the company has already applied for Envlo's product approval in Indonesia, Thailand, and the Philippines.

In addition, Daewoong Pharmaceutical is currently discussing additional technology export contracts and is accelerating its overseas expansion into China, Saudi Arabia, Russia, and other countries. The company plans to cultivate its domestic best-in-class diabetes drug status by entering 15 countries by 2025 and 50 countries by 2030.

The company is also working on securing additional indications and developing combination therapies. A phase 3 clinical trial for insulin combination therapy is currently being conducted in multiple countries as an additional indication for diabetes. The company plans to speed up the development of metformin combination therapy, aiming for its release in the second half of this year, and plans to conduct various studies to secure additional indications for diabetes, as well as for heart, kidney, and obesity.

According to market research firm UBIST, the domestic market size of type 2 diabetes has grown at an average annual rate of 8% over the past five years, reaching around KRW 1.5 trillion last year. In particular, the prescription of single and combination SGLT-2 inhibitors showed the highest growth rate among all diabetes treatments, increasing by KRW 32.6 billion(22% growth) from KRW 150 billion in 2021 to KRW 182.6 billion in 2022.

CEO Lee Chang-jae from Daewoong Pharmaceutical said, "Even before its release, Envlo has been published in international SCIE journals and has already received international recognition for its efficacy and safety, garnering high expectations from both academia and the industry." He added, "As a leading domestic pharmaceutical company, we take pride in our differentiated four-stage verification strategy and sales operations principles to grow Envlo into the best-in-class new drug in the diabetes treatment drug market. We aim to achieve accumulated sales of KRW 100 billion within three years to enable K-Pharmaceutical to grow into a global product."