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Daewoong Therapeutics
Pipeline


Daewoong Therapeutics New Drug Pipeline

Pipeline

Supergenerics & 505(b)(2) Products
Pipeline

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
Modality
Indication
Preclinical/CMC
Clinical Trials
Approval

DWRX1004

Rabeprazole sodium
bicarbonate mix Gastric ulcer, GERD

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DWRX1010

Oral sulfate mix Colon endoscopy preparation

  • 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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DWRX1011

Anti-platelet

DWRX1012

Undisclosed Ulcerative colitis

  • The global ulcerative colitis treatment market is currently about 6 trillion won, and sales of 5-ASA-related drugs, the first-line treatment, account for about 30%

  • 5-ASA preparations are known to be relatively safe compared to other immunosuppressants, but their main purpose is to relieve symptoms

  • As the disease progresses, potent anti-inflammatory/immunosuppressive agents in addition to 5-ASA agents are being used

  • Therefore, as a treatment for ulcerative colitis, there is a great unmet need for a new mechanism, especially a treatment that can heal mucous membranes without immunosuppression

  • DWRX1012 treats the disease by topically applying the drug to the entire large intestine where the main lesions of ulcerative colitis occur

  • DWRX1012 showed a more excellent effect than 5-ASA, the first-line treatment, in the DSS-induced ulcerative colitis model, and showed superior histopathological improvement

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DWRX1013

Pancreatin sodium
bicarbonate mix Exocrine pancreatic insufficiency


 


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