Dong-A ST, which aims to become a global bio company, plans to participate in the 2023 BIO International Convention, to be held in Boston, U.S. ,from June 5 to 8.

Dong-A ST's R&D Center in Songdo, Incheon.
Dong-A ST's R&D Center in Songdo, Incheon.

During the convention, the company will showcase its significant R&D pipeline.

As one of Korea's leading pharmaceutical and biotechnology companies, Dong-A ST has been focusing on discovering and building new growth engines in the R&D sector and strengthening its R&D capabilities in the mid-and long-term since the appointment of Park Jae-hong as president of R&D last year. 

Previously, he led the development of innovative new drugs as a translational research expert at global pharmaceutical companies such as Janssen, Takeda, and Boehringer Ingelheim.

In the short term, Dong-A ST plans to focus on developing products for the growth of prescription drugs, and new drugs in the mid-to-long-term.

To prepare for the cost of developing new drugs, the company is to introduce new prescription drugs centered on treating endocrine, diabetes, digestive, and musculoskeletal systems. The company aims to create a virtuous cycle of investing in new drug development and licensing out such new drugs to secure funding.

Dong-A ST has already gained R&D competitiveness in the endocrine and diabetes fields by developing Suganon, a diabetes treatment.

The company is also conducting R&D in all areas except insulin and is preparing to launch products in the global market.

In the field of the digestive system, the company plans to continue its growth in the Korean market by introducing new products on top of its existing products, such as natural substance products styrene and motiliton, and liquid anti-ulcer drug Gaster.

In the musculoskeletal area, the company plans to develop the growth hormone growtropin into a long-acting injection and introduce additional musculoskeletal products.

The company's plan comes after the musculoskeletal market is expected to grow in Korea due to the population aging.

The company's mid-to-long-term goal is to develop new drugs for cancer, autoimmune and degenerative diseases.

Dong-A ST is developing targeted anticancer drug candidates after licensing-in an anticancer drug substance with PROTAC technology, a protein degradation platform technology jointly developed by the Korea Research Institute of Chemistry Technology and the Korea Research Institute of Bioscience and Biotechnology, in 2021.

In addition, the company is jointly developing an immunotherapy related to immune regulation after licensing-in a drug candidate with a double fusion antibody mechanism from Kanaph Therapeutics.

The substance is an antibody and cytokine fusion protein that delivers cytokines with antitumor effects to the tumor and activates immune cells only around the tumor.

 

Dong-A ST's R&D investments lead to results

The results of Dong-A ST's R&D are also becoming visible.

A representative product is DMB-3115, a biosimilar referencing Stelara that Dong-A ST has been developing to target the global market.

Stelara is an interleukin (IL)-12 and 23 inhibitor class autoimmune disease treatment developed by Janssen and is a blockbuster product with global sales of $9.34 billion in 2021.

Dong-A ST completed the global phase 3 clinical trial for DMB-3115 in November last year and confirmed its therapeutic equivalence and safety compared to the original in January 2023.

In July 2021, Dong-A ST signed a global license-out contract for DMB-3115 with Intas Pharmaceutical, a global pharmaceutical company. Under the contract, it transferred exclusive rights to Intas regarding permits and sales in global regions, excluding Korea and Japan.

Intas plans to commercialize DMB-3115 through its affiliates around the world, including Accord Biopharma in the U.S. and Accord Healthcare in Europe, the U.K., and Canada.

Notably, Intas expects to apply for marketing authorization in the U.S. and Europe in the first half of this year.

Dong-A ST has also confirmed the efficacy and safety of DA-8010, an overactive bladder treatment in a domestic phase 2 trial, and started Phase 3 in March 2022 with 595 patients.

With superior bladder contraction inhibition efficacy and improved bladder selectivity compared to existing antimuscarinic drugs, the company expects that the candidate will show excellent efficacy and improve the side effects of existing therapies, such as dry mouth and constipation.

The company plans to develop DA-8010 as a best-in-class treatment that can be taken once daily.

 

Establishment of global R&D forward base

In December last year, Dong-A ST established a global R&D base by incorporating U.S.-based Neurobo Pharmaceuticals as a subsidiary.

With the geographical advantage of being located in Boston, U.S., and the advantages of being a Nasdaq-listed company, the company expects that the acquisition will make it easier for the company to obtain financing, strengthen cooperation with global pharmaceutical companies and biotechs, and accelerate the global development and commercialization of its new drug pipeline.

Through Neurobo Pharmaceuticals, Dong-A ST plans to develop treatments for type 2 diabetes, obesity, and non-alcoholic steatohepatitis (NASH).

DA-1241, which is being developed as a treatment for type 2 diabetes and NASH, is a GPR119 agonist, which activates GPR119 present in the cell membrane of the intestine and pancreas to enhance blood glucose, protect pancreatic beta cells, and improve lipid metabolism.

The candidate has demonstrated superior glucose control in a U.S. phase 1b clinical trial, and the company has received the go-ahead for the global phase 2 clinical trial.

DA-1726, which is being developed for the treatment of obesity and NASH, is also going through an investigational new drug (IND) application process for a global phase 1 clinical trial.

DA-1726 acts simultaneously on GLP-1 receptors and glucagon receptors to suppress appetite, stimulate insulin secretion, and increase peripheral basal metabolism, ultimately leading to weight loss.

In addition to its weight loss benefits, nonclinical studies have shown potential for development as a treatment for NASH.

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