R&D focus sets Dong-A ST apart in biosimilars

Dong-A ST headquarters in Seoul [DONG-A ST]

Dong-A ST’s consistent focus on research and development (R&D), ranging from biosimilars to anti-obesity drugs, has enabled the pharmaceutical company to make significant strides with new offerings such as the Stelara biosimilar DMB-3115.

One of Korea’s major first-generation bio-medication development corporations, Dong-A ST has a track record of successful drug developments dating back to the 1990s.

The company is responsible for the development of Interferon alpha, G-CSF, a treatment for neutropenia, and Human Growth Hormone (HGH), EPO, a remedy for anemia, and the Follicle-Stimulating Hormone (FSH).

The company is now targeting the global market with its new DMB-3115.

In 2021, the DMB-3115 entered a global phase-3 clinical trial involving 605 patients from nine countries, including the United States. Top-line results have already confirmed its equivalence and safety in January of this year.

In the clinical trials conducted in Europe, the biosimilar demonstrated superior performance, showcasing its properties in just eight weeks — four weeks earlier than its competing product.

Dong-A ST is preparing for its commercialization through a partnership with Intas Pharmaceuticals, a company with sales networks in over 90 countries and experience in commercializing more than 10 types of biosimilars.

The company is also focusing on DA-1726, a candidate substance for anti-obesity drugs, and DA-1241, a treatment for MASH (Metabolic Dysfunction-Associated Steatohepatitis).

DA-1726 is a candidate substance being developed as an anti-obesity drug belonging to the Oxyntomodulin, a hormone found in the colon, category.

Its mechanism induces weight loss and regulates blood sugar by simultaneously affecting GLP-1 and glucagon acceptors, triggering appetite suppression, insulin release and an increased basal metabolism rate.

NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, will initiate global phase-1 clinical trial of the substance in the first half of this year and complete the procedure by the first half of 2025.

Preclinical studies suggested that DA-1726 showed excellent weight loss properties in obese animal models despite consuming diets similar to semaglutide, a GLP-1 analog. The data also indicated that the substance exhibited comparable weight loss efficacy to GLP-1 and Tirzepatide, a dual action drug of GIP, despite increased food intake.

DA-1241 is currently undergoing a global phase-2 clinical trial.
NeuroBo Pharmaceuticals received authorization for phase one of the clinical trial from the U.S. Food and Drug Administration in May last year and issued the first prescription to a patient in September.

A representative of Dong-A ST said, “Through consistent research and development, we will remain faithful to our fundamental role as a pharmaceutical company and strive to improve the quality of life for patients.”

BY JEONG SEONWU [jeong.seonwu@joongang.co.kr]

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