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

• The ultra-small 1cm² patch, which only needs to be applied once a week, dramatically increases user convenience
• Daewoong Therapeutics employs the 'CLOPAM' platform to develop 'advanced formulations,' with plans for commercialization by 2028
• CEO Seung-Ho Jeon states, "By developing the GLP-1 analogue patch-type formulation, we aim to meet the unmet needs of patients and medical professionals."

SEOUL, South Korea, Nov. 7, 2023 /PRNewswire/ -- Daewoong Pharmaceutical (CEOs Seng-Ho Jeon and Chang-Jae Lee) announced on the 6^th that it will commence full-scale development of an obesity treatment utilizing a microneedle patch loaded with GLP-1 (Glucagon-like peptide-1) analogues. The microneedle technology, which involves applying an ultra-small 1cm² patch to the arm or abdomen, represents an advanced formulation that significantly enhances user convenience over traditional obesity treatments. Daewoong Pharmaceutical is set to initiate Phase 1 clinical trials early next year, with the goal of commercializing the product by 2028.

The company is developing an innovative, painless microneedle obesity treatment that can be applied weekly to the arms or abdomen, delivering medication directly through the microvasculature, offering a convenient alternative to traditional, injectable GLP-1 analogue therapies. It maintains the efficacy of existing injectables and offers the significant benefit of room temperature storage, eliminating the need for a cold storage system. This is a marked improvement over oral obesity treatments, which suffer from low absorption rates of about 1% bioavailability and often cause unpleasant side effects such as vomiting, nausea, and diarrhea.

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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