PeopleBio's 'AlzOn' to Enter Japanese Market

PeopleBio's Alzheimer's Disease Blood Test Kit 'AlzOn'
[Photo by PeopleBio]

[Asia Economy Reporter Chunhee Lee] PeopleBio is entering the Japanese Alzheimer's disease blood diagnostic market.

On the 10th, PeopleBio announced that it signed a business agreement with CMIC Holdings, a Japanese contract research organization (CRO) service company, for clinical trials, approval, and sales of PeopleBio's Alzheimer's disease blood test kit, 'AlzOn,' in Japan.

According to this agreement, CMIC Holdings will handle local distribution and sales of AlzOn, as well as the related procedures with the Japanese Ministry of Health, Labour and Welfare (PDMA) and insurance registration. The strategy is to conduct a pilot Alzheimer's disease screening project in one city in Japan during the second quarter of this year, then expand it to other cities, and enter the market after the approval process starting next year. A company official explained, "Considering that product registration with the Ministry of Health, Labour and Welfare typically takes 1 to 1.5 years after the pilot project ends, sales of AlzOn in Japan are expected to be possible around 2025."

Established in 1992, CMIC Holdings is the largest CRO company in Japan, providing clinical trial outsourcing, regulatory approval registration, new drug development and manufacturing, and market solution services in 27 countries including the United States, Europe, Australia, and Southeast Asia.

PeopleBio plans to actively target advanced markets through this agreement. Japan is a super-aged society where about 30% of the total population, approximately 36 million people, are aged 65 or older, and it is expected that by 2025, one in five people aged 65 will suffer from dementia. PeopleBio has also started preparations this year to obtain approval from the U.S. Food and Drug Administration (FDA) for AlzOn, aiming to enter the U.S. market within 2 to 3 years through approval.