[IPO] DT&CRO "Aiming to be a Global CRO Integrating BT and IT"

[Asia Economy Reporter Jang Hyowon] Full-service CRO company DT&CRO is knocking on the door of KOSDAQ. After listing, DT&CRO plans to expand its efficacy center and non-clinical center to increase production capacity.

In November, CEO Park Chaekyu of DT&CRO held a press conference in Yeouido, Seoul, to introduce the business content, core competitiveness, and post-listing plans.

DT&CRO is the only domestic clinical research organization (CRO) capable of providing full-service from non-clinical trials including efficacy and toxicity tests to Phase 1 clinical trials. It has clinical centers, efficacy centers, non-clinical centers, and analysis centers in Seoul and Yongin, securing specialized personnel and infrastructure across all CRO areas, providing connected services at every stage of clinical trials. This helps shorten the clinical and new drug development period.

DT&CRO has been steadily growing in clinical, non-clinical, and analytical CRO business sectors, setting record-high performance every year. In the first half of this year alone, it recorded sales of 23 billion KRW and operating profit of 3.6 billion KRW, representing a significant growth of 64% in sales and 260% in operating profit compared to the same period last year. The compound annual growth rate (CAGR) over the past three years reached 76%.

First, efficacy tests, which evaluate the efficacy of development substances for indications during non-clinical trials, are the most important and essential elements in the early stages of new drug development. As requests to specialized institutions increase, the market size is expected to grow close to 20% by 2023. DT&CRO provides services in various fields including pharmaceuticals, health functional foods, and cosmetics through its efficacy center, and expects to lead sales growth in 2023 through expansion investments made in 2022.

Toxicity (safety) tests serve as preliminary tests for clinical trials and require GLP certification, an OECD mutual recognition standard, for the performing institution. Notably, DT&CRO has developed its own automation programs such as MoPS, LIMS, and CIMS to improve efficiency, and has completed the world's first development of SEND, an electronic document for FDA submissions, providing this service.

In Phase 1 clinical trials, where drug application to humans officially begins, DT&CRO is expanding its market share by providing highly accurate and efficient services using the smart clinical platform STC.

DT&CRO possesses differentiated processes enabled by the combination of biotechnology (BT) and information technology (IT). Representative examples include its proprietary IT platforms such as the ‘SEND Solution’ and ‘STC platform’.

SEND (Standard for Exchange of Nonclinical Data) is an electronic format for submitting non-clinical data to the U.S. FDA when applying for Investigational New Drug (IND) or New Drug Application (NDA). Through the SEND Solution developed by DT&CRO, domestic non-clinical data can be easily and quickly delivered by continuous verification and review until FDA approval is completed, securing a leading position in the domestic market.

STC is the world's first smart clinical platform (Smart Trial Center) applying AI and blockchain technology. Developed in-house to enhance accuracy and efficiency in clinical execution by utilizing biotechnology, IT, and data technology, it has been implemented at Gwangmyeong Hospital Clinical Center to provide highly accurate and efficient clinical services.

With the proceeds from the public offering, DT&CRO plans to significantly expand production capacity by enlarging the currently under-construction efficacy center and non-clinical center. Once the efficacy center is fully operational, it is expected to serve as a cash cow, aiming to become the number one in domestic sales in this field.

To diversify sales, the company plans to invest in PK (pharmacokinetics) and PD (pharmacodynamics) tests, essential in the early stages of new drug development. These will be used as important data for subsequent clinical trials, further strengthening business connectivity.

DT&CRO also aims to expand the application of the smart clinical platform STC, with a vision to set IT standards for clinical trials. Currently applied in Phase 1 clinical trials, it plans to advance the platform and extend it to Phase 2 and Phase 3 clinical trial institutions by 2024.

CEO Park Chaekyu of DT&CRO stated, “With the funds secured through the IPO, we will focus on expanding toxicity, efficacy, and PK/PD tests, and especially make bold investments in the bioanalysis field. Through this, we aim to absorb more than 70% of the protein analysis test demand currently leaking overseas and continue to expand our performance.”

Meanwhile, DT&CRO is conducting a public offering of a total of 1.4 million shares through Kiwoom Securities as the lead manager. The offering price will be determined through demand forecasting on November 26-27, followed by a general subscription from November 2-3 next week. The expected listing date is November 11, with an anticipated market capitalization of approximately 138.9 billion to 157.9 billion KRW after listing.

This content was produced with the assistance of AI translation services.