However, FeliAIM is still a drug in the development stage and has not yet been approved even in Japan. Given that specific results from the clinical trials required for approval have not been disclosed, and considering the policy of prioritizing supply in Japan, it is expected to take more time for the drug to be developed or introduced in Korea.
“30-Year Lifespan” Is an Expectation… Numerous Variables Remain for Domestic CommercializationAccording to the pharmaceutical and biotech industry on the 26th, Japan’s IAM CAT applied to the Ministry of Agriculture, Forestry and Fisheries last April for approval to manufacture and sell “FeliAIM,” a treatment for feline chronic kidney disease (CKD), as a veterinary drug. Pelieim is a treatment currently being developed by a research team led by Toru Miyazaki, director of the AIM Research Institute and a former professor at the University of Tokyo. IAM CAT was established to conduct clinical trials and commercialize AIM’s treatments.
The phrase “a cat’s lifespan of 30 years” became widely known through Director Miyazaki’s 2021 book, *The Day Cats Live to Be 30*. The concept suggests that while the average lifespan of a cat is approximately 15 years, preventing and treating CKD could potentially nearly double that duration.
CKD is a disease in which kidney tissue is damaged over a long period, leading to a gradual decline in the excretion of waste products and the regulation of water and electrolytes. It has a particularly high incidence rate in cats, and since kidney function is difficult to restore once damaged, it is considered a major cause of reduced lifespan. According to the International Society of Feline Medicine (ISFM), 30–40% of cats aged 10 years or older are affected by CKD.
Pelieim is a therapeutic agent that administers the AIM protein—which is not sufficiently activated within a cat’s body—externally in the form of a recombinant protein. AIM promotes the removal of necrotic cells and waste products accumulated in the renal tubules. However, unlike in other mammals, feline AIM does not separate well from immunoglobulin M (IgM) in the blood, preventing it from moving sufficiently into the tubules even when kidney damage occurs. Director Miyazaki’s research team explains that this delays recovery from kidney damage and may increase susceptibility to the progression of chronic kidney disease.
IAM CAT began a clinical trial for Pelie-AIM approval last May at 26 veterinary hospitals in Japan. In a presentation at Interpet Osaka in June, Director Miyazaki reported that 60 cats with kidney disease participated in the trial and that their survival rates improved significantly.
However, the specific design of the trial, as well as details regarding survival rates, statistical significance, safety, and adverse reactions, have not yet been disclosed. The currently available clinical evidence consists of exploratory and non-confirmatory studies conducted separately from the Peli-AIM regulatory clinical trial. In these studies, only 11 cats actually received the recombinant AIM.
Nevertheless, Director Miyazaki explained in a recent interview that he plans to hold an initial review meeting with the Ministry of Agriculture, Forestry and Fisheries in early July, noting that the review is proceeding quickly because the number of questions received in advance was fewer than expected. When he stated that, based on this, the product’s launch was imminent, speculation arose that the review was proceeding relatively smoothly, leading to the spread of related information within South Korea as well.
Since Director Miyazaki has stated a policy of prioritizing supply to Japan, even if efforts are made to introduce the product in Korea after it receives marketing authorization in Japan, there is a high likelihood of a significant time lag before its launch. IAM CAT plans to first meet domestic demand in Japan before supplying overseas, taking into account the possibility of limited initial supply volumes.
Domestic Development in Its Infancy… Market Viability Remains a Challenge
in South Korea. The company leading the way is curacle co., ltd.(365270). curacle co., ltd. is developing “CP01-R01,” an endothelial dysfunction inhibitor, as a treatment for chronic kidney disease in dogs.
Unlike dialysis, which removes waste products accumulated in the kidneys, CP01-R01 is a candidate drug that normalizes impaired vascular endothelial function and suppresses inflammation. After receiving approval for its Phase 3 clinical trial plan from the Animal and Plant Quarantine Agency in February of last year, the company is currently conducting a clinical trial involving 60 dogs with CKD. However, the Phase 3 indication is for dogs, not cats. To develop it as a treatment for cats, additional verification of dosage, pharmacokinetics, and safety—taking species differences into account—is required.
Last May, in a shareholder letter marking its 10th anniversary, curacle co., ltd. stated, “Chronic kidney disease is a condition with a high prevalence not only in dogs but also in cats,” adding, “We are preparing additional research targeting cats through collaboration with government agencies.”
Domestic new drug development specifically targeting cats is still in its early stages, having just begun as part of a government-funded project. A consortium led by Cha University of Science and Technology, with participation from Matica Bio Labs, GC Biopharma Corp., and Anicom Medical Center, launched the government-funded project “Development of Advanced Biopharmaceuticals for Feline Kidney Failure Based on Stem Cells” in April of this year. The research period runs through December 2031. The goal is to verify the anti-inflammatory, immunomodulatory, and tissue-protective potential of stem cells and to advance the project through clinical trials, regulatory approval, manufacturing, and commercialization.
In addition, companies such as Anibiome and Graycot Research are also pursuing products and diagnostic and management services related to feline kidney disease; however, their efforts are reportedly focused on therapeutic adjuvants, precision nutrition, and genetic analysis rather than new drug development.
Market viability issues underlie the slow pace of domestic development. According to the Korea Animal Pharmaceutical Association, the domestic market for companion animal pharmaceuticals is valued at 289.6 billion won in 2024. While growth potential is high, the market is still considered too small to recoup the costs of new drug development and investments in clinical trials and production facilities.
The fact that veterinary clinics can purchase and use prescription human medications for treatment purposes is also cited as a factor that reduces the incentive to develop drugs specifically for pets. In fact, according to data submitted by the Ministry of Health and Welfare to Rep. Seo Young-seok of the Democratic Party of Korea (Bucheon-gap, Gyeonggi Province), a member of the National Assembly’s Health and Welfare Committee, 5,603 veterinary clinics received human medications in 2024—a 64.2% increase from 2020. The explanation is that, given the availability of treatments using existing human medications—such as blood pressure medications, antiemetics, and intravenous fluids—it is difficult for new drugs specifically developed for companion animals to secure price competitiveness.
An official in the biotech industry stated, “Although cats have a high prevalence of kidney disease due to factors such as their tendency not to drink enough water, there are virtually no facilities in Korea conducting clinical trials specifically on cats. Currently, human medications, such as blood pressure drugs, are often prescribed to animals,” the official said. “Although the pet industry is considered a future high-value-added sector, the domestic market for pet-specific medications remains small. Given the market size and the burden of clinical trials, it is difficult for companies to invest in new drug development over the long term.”
