DAEWOONGRX

Our focus is on completing the preclinical and CMC for supergenerics and 505(b)(2) products, bringing these assets to the clinical stage for co-development or transfer to partners prior to bioequivalence and/or other applicable studies. This strategy streamlines early-stage drug development, reducing risks and costs, and offers clinically prepared products to our partners. Crucially, our commitment extends beyond the transfer or co-development agreement, ensuring we provide continued support and collaboration to facilitate successful market entry and approval in their regions of interest. The following is a list of currently available programs for co-development or regional licensing.

Code name

Indication

Preclinical/CMC

Clinical Trials

Approval

DWRX1004

Gastric ulcer, GERD

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DWRX1010

Colon endoscopy preparation

NDA submitted (KR) / Expected Approval in 1H of ‘25)

Colonoscopy is a test method for diagnosing inflammation, polyps, tumors, etc. in the large intestine by observing the large intestine by inserting an endoscope through the anus. Colonoscopy is not only for the purpose of examination, but also for biopsies of abnormal areas, direct removal of polyps, and hemostasis in case of bleeding, so it can be performed for therapeutic purposes as well.
Taking the prescribed enema according to the examination schedule and emptying the intestines is essential for an accurate examination, and PEG-based formulations, SPMC formulations, and sulfate-type laxatives are largely used.
Existing formulations show very low medication compliance due to unpleasant taste and smell, excessive water or solid dosage, etc.
DWRX1010 tablets are a new colon cleanser that shows the world's highest level of drug compliance/bowel cleansing, and aims to start clinical trials in 23 and launch in 24 by securing excellent animal efficacy.
We signed a technology transfer contract with Daewoong Pharmaceutical, which has the nation's best clinical development and marketing capabilities for digestive medicine.

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DWRX2008

Diabetic retinopathy