When it comes to cancer, except for blood cancer, it is generally diagnosed by biopsy. However, there is a way to diagnose cancer without a biopsy. Radiopharmaceuticals are the answer.

The frontrunner in the Korean radiopharmaceutical market is DuoChemBio. Although a latecomer, it covers a full range of business from development to manufacture, transport, and supply, to account for 80 percent of the fludeoxyglucose (FDG) 18F Injection market.

Currently, the company is strengthening its competitiveness based on five products. They are three products for diagnosing brain diseases -- FP-CIT for Parkinson’s disease, F-DOPA for a brain tumor, and VIZAMYL for Alzheimer’s disease – and FES for breast cancer and FACBC for pancreatic cancer, according to DuChemBio’s website.

DuChemBio’s growth potential does not stop here. On Jan. 11, it won the U.S. Food and Drug Administration’s fast-track approval for Alzheimer’s treatment Leqembi (lecanemab), for which the company participated in clinical trials for five years, drawing the industry’s attention along with developers, Eisai and Biogen. If lecanemab is commercialized, the demand for VIZAMYL, which can measure amyloid beta density, will likely increase, too.

Korea Biomedical Review met with CEO Kim Jong-woo to learn how DuChemBio has come to lead the domestic radiopharmaceutical market and stand shoulder-to-shoulder with global companies.

Question: How did DuChemBio jump into the radiopharmaceutical market?

Answer: Some 30 or 40 years ago, the domestic pharmaceutical market was led by generic drugs instead of developing new drugs. In 2002, we had our first contact with radiopharmaceutical products while conducting a health-functional food distribution business. We found it a unique business with many advantages, although with high entry barriers. We were also convinced that it was the only industry where we could compete equally with global companies. So we jumped into the business by acquiring a manufacturing facility for radiopharmaceutical products in 2007.

Q: We heard DuChemBio is the frontrunner in the radiopharmaceutical market with a market share of 80 percent. How many radiopharmaceutical companies are in Korea now, and how could you emerge as a market leader as a latecomer?

A: In the radioactive drug market, possessing radioisotope manufacturing plants determines competitiveness. This is because radioactive isotopes have a very short expiration period (eight to 10 hours) compared to general medicine products. So, first, we tried to establish manufacturing plants that could supply radiopharmaceuticals to nearby institutions, such as hospitals. In addition, DuChemBio’s manufacturing plants focused on receiving GMP (good manufacturing practice) certification, a global condition that guarantees drug stability and effectiveness. It currently operates 12 manufacturing plants, including six with certifications. As a result, its FDG-based cancer diagnosis products account for 80 percent of the domestic radiopharmaceutical market.

We also could become the market leader, although we were a latecomer, thanks to our intensive investment into developing new drugs instead of remaining complacent with existing products.

As a result of actively developing excellent radiopharmaceutical products in collaboration with Korean and foreign organizations and drugmakers, we could have products diagnosing Parkinson’s disease (FP-CIT), Alzheimer’s (VIZAMYL), brain tumor (F-DOPA), pancreatic cancer (FACBC), and breast cancer (FES). In addition, we participated in the domestic clinical trial of Alzheimer’s treatment developed by multinational companies, making DuChemBio’s name known abroad.

Thanks to such efforts, we had become one of only three radiopharmaceutical companies, along with FutureChem KaiBioTech, although there were six when we jumped into the market.

Q: Can you select three or four of your hit items?

A: The most representative and basic radiopharmaceutical product is FDG. It is used to diagnose systemic cancer. Using FDG, a glucose analog, we can diagnose tumors with faster metabolism and growth than normal cells. Therefore, it is a meaningful product that a radioactive drug company must have.

Besides, I can pick FP-CIT, diagnosing Parkinson's disease, and VIZAMYL diagnosing Alzheimer's dementia. FP-CIT is the world's first new drug to diagnose brain function related to Parkinson's disease with images by determining the density of dopamine carriers in the brain's striatum and identifying Parkinson's disease. We plan to conduct a phase 3 clinical trial in China.

VIZAMYL is the only radiopharmaceutical product that allows the brain of dementia patients to be read with color images. It can diagnose amyloid beta density in dementia patients. VIZAMYL is the radiopharmaceutical product for diagnosing Alzheimer’s used in the clinical trial of dementia treatment lecanemab developed by Biogen and Eisai and approved by the FDA after a fast-track review.

There is also a new drug called F-DOPA, the world's first new drug for diagnosing brain tumors applied by neutralization. It diagnoses tumors that cannot be diagnosed by existing FDG and have received health insurance benefits since July last year. In addition to brain tumors, it also has indications for Parkinson's disease.

In addition, there is FACBC, which diagnoses prostate cancer. FACBC is Korea's first radiopharmaceutical product for prostate cancer diagnosis. It is used for the positron emission tomography-computer tomography (PET-CT) of patients suspected of recurrence due to elevated prostate-specific antigen in the blood after prostate cancer treatment. It is being sold in Europe and the U.S. and was launched in Korea last November.

Q: After dementia treatment, lecanemab won fast-track approval, and DuChemBio also seems to have received attention. If lecanemab is commercialized, what influence will it exert on DeChemBio?

A: While conducting lecanemab’s clinical trial in Korea, our Alzheimer diagnosis radiopharmaceutical product VIZAMYL was used on about 200 patients for five years. However, its introduction to Korea will likely take some time due to procedures, including approval from the Ministry of Food and Drug Safety. We expect it will be the earliest second half of next year. As the growth of dementia diagnosis technology is rapid, we expect the release of lecanemab to contribute to the sales growth of DuChemBio greatly.

Q: Do you have products under development now?

A: We are expanding pipelines by establishing global networks, such as joint research with radiopharmaceutical companies from many countries worldwide. For example, we have two – breast cancer diagnoses, 18F-FES and prostate cancer diagnosis 68Ga-PSMA-11 – approved and evaluated for new medical technologies through phase 3 clinical trials. In addition, there are three types of products in the clinical stage -- dementia diagnosis Cerveau MK-6240, progressive nuclear paralysis dementia diagnosis LMIPI-2620, and human immunotherapy diagnosis Zr-89 Crefimirlimab Berdoxam – targeted at commercialization in three to five years.

Q: What are your plans to advance to overseas markets?

A: It seems a long way off for us to go abroad directly. Rather, like the lecanemab case, we will continue strengthening cooperation with multinational pharmaceutical companies to develop therapeutic radiopharmaceutical products.

Therapeutic radiopharmaceutical products have a longer expiration date than diagnostic products so that they can be traded internationally. We will try to establish DuChemBio as a hub company in the Asian market so that multinational pharmaceutical companies can choose us when they expand their markets to the Asian region.