Kang Stem Biotech announced on December 5 that the Ministry of Food and Drug Safety of South Korea approved the initiation of the third phase of the clinical trial of Furestem-AD, the world’s first stem cell-based atopic dermatitis drug it is currently working on.
Regarded as a highly innovative new drug, Furestem-AD proved its efficacy in more than half of patients in the previous clinical trials. Kang Stem Biotech is planning to start the third phase soon with approximately 200 patients in seven hospitals in South Korea and complete the process within one year before asking for a license to sell it.
According to market research firm Global Data, the number of atopic dermatitis patients is estimated to reach 138 million worldwide in 2022. Under the circumstances, more and more pharmaceutical companies are working on drugs for such patients. For example, Novartis recently began to develop one after acquiring Ziarco late last year. Pfizer acquired Anacor for US$5.2 billion in May this year and obtained an approval from the U.S. Food and Drug Administration for the sale of Eucrisa. In March this year, Sanofi released Dupixent in the United States.
Qurient, a South Korean venture firm, recently finished the second phase of its clinical trial for Q301 in the United States and is currently preparing to export the technology. JW Pharmaceutical’s FR-1345 has been selected as an item of South Korea’s national new drug development team. Developed by C&C Research Laboratories, FR-1345 enters the first phase of its clinical trial next year. C&C Research Laboratories is a joint venture of JW Pharmaceutical and Chugai Pharmaceuticals, which is a Japanese company.
“Existing atopic dermatitis drugs are not free from side effects and their efficacy has been limited to symptom alleviation,” the Korea Biotechnology Industry Organization explained, adding, “However, stem cell-based products are expected to remove the fundamental cause of the disease once put to commercial use.”