Approval of Alzheimer's Drug ‘Donanemab’ Brings Positive Outlook for Duchembio

The FDA approval of Eli Lilly's 'Donanemab' (marketed as Kisunla), the third Alzheimer's treatment globally, is anticipated to create a positive ripple effect for radiopharmaceutical companies involved in Alzheimer's diagnostics.

Donanemab operates similarly to 'Lecanemab' (marketed as Leqembi), jointly developed by Biogen and Eisai. Both therapies are targeted treatments designed to prevent the accumulation of the toxic protein beta-amyloid in the brain. Beta-amyloid buildup is known to accelerate the progression of Alzheimer's disease due to its neurotoxic effects.

To use treatments like Lecanemab or Donanemab, it is crucial to conduct brain imaging to measure the amount of beta-amyloid in the patient's brain tissue before starting treatment. The most commonly used method for this is positron emission tomography (PET) scanning.

PET scans work by injecting radiopharmaceuticals that emit positrons into the bloodstream and visualizing their distribution within the body. The quality of these radiopharmaceuticals is critical, and the global approval of beta-amyloid-targeted therapies has highlighted their importance.

In South Korea, Duchembio, a subsidiary of GeoYoung, leads this market. According to the Ministry of Food and Drug Safety's integrated drug information system, Duchembio holds over 90% of the domestic market for beta-amyloid PET diagnostic agents.

With the successive approvals and anticipated domestic launches of Lecanemab and Donanemab, Duchembio expects a significant increase in demand for PET diagnostic agents. Lecanemab is likely to be released domestically within the year, and Duchembio has been supplying PET diagnostic agents for Donanemab's bridging clinical trials since December last year. These trials are expected to continue until the first half of 2027.

Once these treatments begin actual prescriptions in Korea, the demand for PET scans is projected to increase dramatically, as each treatment requires multiple PET scans (four for Lecanemab and five for Donanemab). Additionally, the domestic release of these drugs may inspire Korean companies to develop similar treatments.

Kim Sang-woo, CEO of Duchembio, stated, “In 2023, approximately 3.38 million people in Korea are estimated to have mild cognitive impairment or early dementia. Based on this, the market size for PET radiopharmaceutical diagnostic agents is estimated to be around 1.6 trillion KRW(1.216 billion USD). As a company supplying diagnostic agents for clinical trials, we are committed to ensuring the smooth domestic supply of new drugs with a sense of responsibility and mission.”