Daewoong Pharmaceutical to Initiate Clinical Trials Early Next Year for Innovative 'GLP-1 Obesity Treatment' with Advanced Microneedle Technology for Sustained Weekly Efficacy

Daewoong Therapeutics (CEO Bokki Kang), a subsidiary of Daewoong Pharmaceutical, has completed preclinical studies and compiled data for a microneedle patch within the Semaglutide series, a GLP-1 analogue, using its proprietary 'CLOPAM' (Closed-Packed Aeroperssured Microneedle) platform. This platform is secured by 6 international (Patent Cooperation Treaty, PCT) and 23 domestic patents, of which 5 are registered, encompassing various aspects of manufacturing and packaging. The technology addresses previous challenges, significantly enhancing drug uniformity, preventing contamination, and ensuring stability. The microneedle manufacturing technology preserves the integrity of the biodegradable needles, which are sensitive to moisture and impact, until they are used. These soluble microneedles release the drug into the body as they dissolve.

Daewoong Therapeutics (CEO Bokki Kang), a subsidiary of Daewoong Pharmaceutical, has completed preclinical studies and compiled data for a microneedle patch within the Semaglutide series, a GLP-1 analogue, using its proprietary 'CLOPAM' (Closed-Packed Aeroperssured Microneedle) platform. This platform is secured by 6 international (Patent Cooperation Treaty, PCT) and 23 domestic patents, of which 5 are registered, encompassing various aspects of manufacturing and packaging. The technology addresses previous challenges, significantly enhancing drug uniformity, preventing contamination, and ensuring stability. The microneedle manufacturing technology preserves the integrity of the biodegradable needles, which are sensitive to moisture and impact, until they are used. These soluble microneedles release the drug into the body as they dissolve.

Morgan Stanley forecasts a substantial expansion in the global obesity treatment market, with expectations to reach 104 trillion won by 2030. Daewoong Pharmaceutical is poised to enter this market with its innovative microneedle obesity treatment by 2028, aiming to revolutionize the sector by addressing the limitations of current therapies, especially in improving treatment adherence—a significant challenge highlighted by Eli Lilly's CSO, Dr. Dan Skovronsky. This novel treatment, nearing Phase 1 clinical trials, could help prevent weight regain post-GLP-1 analogue use by mimicking the incretin hormone to suppress appetite and regulate blood sugar, thus aiding in the management of obesity and diabetes.

Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, remarked, "Last year, Daewoong Pharmaceutical declared the '2030 Global Formulation No.1' vision and has since been dedicated to new administration route technology, specifically microneedles. We aim to fulfill the unmet needs of medical professionals and patients by developing a patch-type formulation of GLP-1 analogues, which are garnering global attention."

About Daewoong Therapeutics

Daewoong Therapeutics, a member of the Daewoong Group since February 2019, specializes in R&D for medical and pharmaceutical breakthroughs. Its primary focus areas include microneedle drug delivery systems, treatments for eye diseases, and small molecule drugs for cancer. The company recently received Phase 1 IND approval for the first eye drop treatment for diabetic retinopathy, utilizing Enavogliflozin from Daewoong Pharmaceutical's Envlo.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials.

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