Daewoong Pharmaceutical(Daewoong), Korea's first SGLT-2 inhibitor diabetes drug 'Envlo (Enavogliflozin)' was recognized for its excellent efficacy and safety and passed the Pharmaceutical Affairs Committee review at 40 major general hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Asan Medical Center, and Severance Hospital. recently announced that it did.
Daewoong plans to expand Envlo's prescriptions to hospitals nationwide and expects sales to grow in earnest from the fourth quarter of this year. Daewoong is also actively seeking to advance into the global diabetes market.
According to 'RENUB Research', the global diabetes market is expected to grow to USD 82.92 billion (approximately KRW 108.5 trillion) by 2027. Accordingly, Daewoong submitted NDAs to Indonesia, the Philippines, Thailand, and Vietnam to advance into the global market.
Daewoong plans to advance into 15 countries by 2025 and 50 countries by 2030 to develop it into the best-in-class diabetes drug market.
Envlo showed equal or better efficacy with just 0.3 mg, which is 1/30 of the previously released SGLT-2 inhibitor. In phase 3 clinical trials conducted for type 2 diabetic patients, Envlo demonstrated superior glycated hemoglobin (HbA1c) and fasting blood sugar lowering effects and safety compared to existing commercially available drugs. The proportion of patients whose glycated hemoglobin decreased by more than 0.5 percentage points compared to before treatment also recorded a maximum of 82.9%. The rate of decrease in the same class of drugs was 40-60% compared to Enblo.
In particular, Envlo showed effects of reducing weight, reducing blood pressure, improving lipid profile, and improving insulin resistance in licensed clinical studies, and showed superior blood sugar lowering effects and proteinuria improvement effects compared to drugs of the same class in type 2 diabetic patients with reduced renal function.
Daewoong CEO Lee Chang-jae said, "Daewoong Pharmaceutical will achieve cumulative sales of KRW 100 billion by 2026 based on its accumulated R&D capabilities and sales capabilities in the endocrinology market."
By_BK Min, KDFN kdf@kdfnews.com
The summary of this article in Korean is as follows.
■대웅제약, 당뇨병 신약 ‘엔블로’ 4대 종합병원 입성
대웅제약은 SGLT-2 억제제 당뇨병 신약 ‘엔블로(이나보글리플로진)’가 삼성서울병원과 서울대병원, 서울아산병원, 세브란스병원 등 주요 종합병원의 약사위원회를 연이어 통과했다고 10일 밝혔다.
엔블로는 출시 3개월 만에 서울 주요병원을 비롯해 전국 주요 대학병원과 종합병원 등 40개가 넘는 병원의 약사위원회에 통과했다. 대웅제약은 엔블로 처방처를 전국 병원으로 더욱 넓힐 계획이다.
대웅제약은 글로벌 당뇨병 시장에도 적극적으로 진출하고 있다. 올해 상반기에만 인도네시아와 필리핀, 태국, 베트남 등에 품목허가신청서(NDA)를 제출했다. 오는 2025년까지 15개국, 2030년까지 50개국에 진출해 국산 최고 당뇨병 신약으로 육성시킬 계획이다.
엔블로는 기존 출시된 SGLT-2 억제제의 30분의 1 이하에 불과한 0.3mg만으로 동등 이상의 약효를 보였으며, 제2형 당뇨병 환자를 대상으로 진행한 임상 3상을 통해 기존 시판약물 대비 뛰어난 당화혈색소·공복혈당 강하효과∙안전성을 입증했다.
이창재 대웅제약 대표는 “대웅제약이 쌓아온 R&D 역량과 내분비내과 시장에서 구축해온 강력한 영업력을 바탕으로 출시 3년 차인 2026년 엔블로의 누적 매출 1천억원을 달성해낼 것”이라고 말했다.
사진 대웅제약
박성재 기자 kdf@kdfnews.com
