'36th Domestic New Drug' Diabetes Treatment
"Also Pursuing Indications for Obesity, Heart, Kidney, Liver, Brain, and Ophthalmology"
[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical's new diabetes drug, Enblo Tablets (active ingredient: Inavogliflozin), has won the Grand Prize in the New Drug Development category at the 24th Korea New Drug Development Award (KNDA). Notably, Daewoong Pharmaceutical also received the same award at the previous 23rd KNDA for its new drug for gastroesophageal reflux disease, Pexuclu Tablets, marking the honor of winning two years in a row.
Daewoong Pharmaceutical announced on the 22nd that it received the Grand Prize in the New Drug Development category at the 24th KNDA, organized by the Korea New Drug Development Association and sponsored by the Ministry of Science and ICT, the Ministry of Health and Welfare, and the Ministry of Trade, Industry and Energy, in recognition of its development of Enblo Tablets. The award ceremony will be held on the 24th at the Samjung Hotel in Gangnam-gu, Seoul.
KNDA was established in 1999 to promote the development of Korea's bio-health industry and the motivation for new drug research and development (R&D), and to commemorate the achievements of companies that have succeeded in developing high value-added new drugs and those that have created new technologies or exported technologies. The awardees are selected through objective and rigorous evaluations over three rounds based on eligibility criteria, novelty, technological level, added value, technology and market competitiveness, and contribution to public health improvement. The award categories are new drug development and technology export.
Daewoong Pharmaceutical's diabetes treatment 'Enblo (active ingredient: Inavogliflozin)' logo [Photo by Daewoong Pharmaceutical]
Enblo Tablets work by selectively inhibiting the sodium-glucose co-transporter 2 (SGLT-2) located in the proximal tubules of the kidney, which is involved in glucose reabsorption, thereby directly excreting glucose through urine and reducing blood sugar levels. The company explained, "Clinical trials have demonstrated superior blood sugar and glycated hemoglobin (HbA1C) lowering effects and safety compared to existing marketed drugs." Additionally, the proportion of patients achieving global standards for diabetes control was over 20% better than existing SGLT-2 inhibitors, and the proportion of patients with a reduction in HbA1C exceeding 0.5% compared to before treatment reached up to 82.9%, significantly higher than the 40-60% level seen with drugs in the same class, further proving its excellent HbA1C reduction effect. It also showed effects in weight loss, blood pressure reduction, lipid profile improvement, and insulin resistance improvement, with infection-related side effects observed to be very low compared to other drugs in the same class.
Daewoong Pharmaceutical began developing Enblo Tablets in 2016, obtained marketing authorization from the Korean Ministry of Food and Drug Safety in November last year, and aims to launch domestically in the first half of this year. Clinical trials are also underway for entry into major global markets such as China and Japan. Daewoong Pharmaceutical plans to submit approvals in 10 countries annually and expand to 50 countries globally by 2030 to develop Enblo Tablets into a global blockbuster.
With this, Daewoong Pharmaceutical has earned its fifth award at KNDA. It previously won the Excellence Award at the 4th KNDA (EasyGF External Solution), the Technology Export Award at the 15th KNDA (Nabota), and the Technology Award at the 16th KNDA (Ollosta Tablets), and received the Grand Prize in the New Drug Development category at the 23rd KNDA for Pexuclu Tablets. This year, it has again won the Grand Prize for two consecutive years with Enblo Tablets.
Seungho Jeon, CEO of Daewoong Pharmaceutical, said, "Winning the Grand Prize in the New Drug Development category for two consecutive years demonstrates Daewoong's R&D capabilities," adding, "Based on Enblo's excellent efficacy, we will expand various indications beyond diabetes treatment to obesity, heart disease, kidney disease, liver disease, brain disease, and ophthalmic disease areas, nurturing it as the best new drug in its class."
Meanwhile, at the 3rd Bio Industry Merit Awards ceremony, which will be held alongside the KNDA awards, Jisoo Choi, team leader at Daewoong Pharmaceutical who played a pivotal role in the development of Enblo Tablets, will be recognized for her contributions to the advancement of Korea's bio industry and receive a commendation from the Minister of Science and ICT. Team Leader Choi led the development and manufacturing approval acquisition of Enblo Tablets and played a key role in securing superior efficacy and tolerability compared to existing drugs through non-clinical and clinical trials.
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