[Edaily Reporter YU JIN-HEE ] “Once our independently developed eco-friendly quantum dot (QD) diagnostic platform gains a foothold in the global market, we can achieve sales of over 80 billion won from this single product line alone, and ultimately reach the 100 billion won range. Building on our new in vitro diagnostic technology and solid profitability, we will list on the KOSDAQ market and usher in an era of annual sales exceeding 200 billion won.”

Oh Se-mun, CEO of SG BioScience (formerly SG Medical, hereinafter SG Bio), recently met with E-Daily to present the company’s mid- to long-term growth strategy and roadmap for its IPO.

Full-Scale Entry into Global Markets: Regulatory Approval Process Underway

SG Bio, a company specializing in in vitro diagnostics, previously officially unveiled its next-generation multiplex point-of-care testing (POCT) platform, “InstaQ,” and its dedicated reader, “InstaRead M,” at the Seegene Art Hall in the Seegene Medical Tower in Dongdaemun-gu, Seoul. This marks the first tangible result of consolidating the company’s core research and development (R&D) capabilities accumulated over several years.

CEO Oh expressed confidence in a strong rebound in earnings following the launch of the new products. InstaQ is a fluorescent immunoassay (FIA) medical device that detects four major respiratory pathogens from nasopharyngeal samples in just 20 minutes. It has received product approval from the Ministry of Food and Drug Safety (MFDS), validating its reliability.

“We can generate over 30 billion won in sales within two years of the new product’s launch,” he said, adding, “Once we are fully established in the market, sales from this product alone are expected to grow to 100 billion won.”

The company plans to focus on the global market rather than the domestic market to achieve results. In fact, the process of obtaining country-specific approvals for global market entry is already well underway. Official applications have already been submitted to emerging markets such as Vietnam and Uzbekistan, where the MFDS approval is recognized. Preparations for entering the massive European market are also proceeding smoothly.

CEO Oh explained, “We have signed a contract with Italy’s MD Healthcare to conduct clinical trials in Europe,” adding, “We expect to obtain authorization under the European In Vitro Diagnostic Medical Devices Regulation (IVDR) around next fall.”

Securing IVDR certification will open up distribution channels across Europe. The company is also undergoing the approval process with the Thai Food and Drug Administration (TFDA), a key medical hub in Southeast Asia. The company is pursuing entry into the U.S. market with a completely revised strategy. The U.S. is a key market with a market size reaching the trillions. The company has learned from its past experiences during the COVID-19 pandemic, when it suffered two setbacks while attempting to secure approval directly in the U.S. market.

CEO Oh stated, “We plan to partner with global in vitro diagnostics companies or local distributors through an Original Design Manufacturer (ODM) model,” adding, “Development is already complete, and we will soon send formal proposals to overseas partners.” Under this model, the partner company will directly obtain approval from the U.S. Food and Drug Administration (FDA), while the company will handle manufacturing and be granted exclusive distribution rights for the U.S. and South America.

Breaking Free from the “Seegene Captive” Label… Aiming for KOSDAQ Listing on the Back of a Rebound in Earnings

The core competitive advantage of the new product lies in its proprietary, non-toxic indium phosphide quantum dot (QD) material. Quantum dots (QDs)—ultra-fine semiconductor nanoparticles with a diameter of 10 nanometers (nm) or less—are a cutting-edge new material that garnered attention following the 2023 Nobel Prize in Chemistry. Compared to gold particles or organic fluorescent substances used in existing rapid diagnostic kits, they offer superior light stability and a stronger luminescent signal.

They have also completely eliminated cadmium, which was a limitation of early QD materials due to its toxicity. By independently synthesizing a non-toxic indium phosphide (InP)-based material, the company has overcome barriers related to environmental regulations and human health risks. In comparative clinical trials at major university hospitals, including Gangnam Severance Hospital, the test recorded a sensitivity of 92.9–97.1% and a specificity of 99.8–100% for the detection of respiratory viruses. It also demonstrated excellent detection performance even in early-stage infection samples with low viral load.

The dedicated reader, InstaRead M, also overcomes the limitations of visual interpretation in rapid diagnostic kits. It quantifies minute fluorescent signals to produce consistent results regardless of the tester’s skill level. Measurement data is automatically synchronized with the hospital’s Laboratory Information System (LIS), reducing administrative burdens and errors. When used with a reaction chamber device, continuous reading is possible within one minute, making it particularly effective in large hospital emergency rooms or screening clinics.

CEO Oh emphasized the unlimited scalability of the quantum dot diagnostic platform. The company is preparing a pipeline of six diagnostic kits, expanding from the current four respiratory disease kits to include adenovirus and others. It is also broadening its product lineup into the cardiovascular disease sector, including tests for sexually transmitted infections (STIs) and biomarkers for myocardial infarction. Myocardial infarction is an area where the platform’s utility can be maximized, as rapid on-site results are essential for determining the need for emergency surgery. In the long term, the company plans to expand its lineup to include cancer biomarkers and tests for hormonal disorders.

The company is also rapidly reducing its reliance on the Seegene Medical Foundation, an affiliate of its largest shareholder. During the COVID-19 pandemic, the Seegene Medical Foundation’s share of revenue soared to the high 70s percent as demand for diagnostic reagents and viral transport media (VTM) surged. As earnings volatility increased following the transition to an endemic phase, the company focused on reducing internal transactions and diversifying its business.

CEO Oh stated, “As of the first half of this year, the Seegene Medical Foundation’s share of total revenue has dropped to around 50 percent,” adding, “Once sales of new products gain momentum, we plan to achieve a ‘7:3 golden ratio’—with 70 percent external revenue and 30 percent internal revenue—within three years, after first reaching a 6:4 ratio.”

Thanks to management efficiency improvements and business restructuring, a rebound in performance has become visible. After divesting unprofitable businesses last year and reorganizing the company around core technologies, the company successfully returned to profitability, recording annual revenue of 120.6 billion won and an operating profit of 2.4 billion won. Expanding the exclusive domestic distribution network for Hitachi’s automated analyzers to major university hospitals also played a key role. This year, the company is expected to achieve annual revenue of over 130 billion won, and by expanding the proportion of high-value-added in-house production, it is projected to generate annual operating profit of over 5 billion won.

Having restored financial soundness and reduced the proportion of related-party transactions, SG Bio is accelerating preparations for a KOSDAQ listing, targeting next year. To meet the Korea Exchange’s strict criteria for related-party transactions, the company has firmly established business independence and diversified its client base.

CEO Oh emphasized, “Although we had met the size requirements, we had postponed our listing efforts because we judged that our proprietary technology and business independence were not yet sufficient,” adding, “Now that we have established a solid foundation—including a stable profit trend and the commercialization of our proprietary QD platform—we will complete our KOSDAQ listing next year through a straightforward approach.”

He continued, “We will transcend the confines of the Seegene network and secure a fair valuation on the global in vitro diagnostics stage through our unrivaled technological capabilities,” adding, “By successfully launching new products, we will leap forward as a strong, agile biotech company that will soon surpass 200 billion won in consolidated revenue.”