Bifido Strain Registration in China Underway... "Expect Completion by 2022"

[Asia Economy Reporter Hyunseok Yoo] Bifido announced on the 28th that since last year, it has been in the process of registering the Bifidobacterium bifidum BGN4 strain with the Chinese National Health Commission and is currently undergoing toxicological evaluation.

Based on the immunomodulatory effects of the Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI strains it holds, Bifido is conducting research and development on treatments for rheumatoid arthritis and various autoimmune diseases using strains that exhibit excellent inflammatory immune regulation activity through dendritic cells.

In June of last year, Bifido became the first domestic microbiome company and the sixth worldwide to receive GRAS certification from the U.S. Food and Drug Administration (FDA). GRAS certification is a system where FDA experts evaluate the safety of a substance under its intended conditions of use and certify it as safe. It applies to highly safe foods and food chemicals and is internationally recognized, not only in the U.S., making it a certification that many pharmaceutical and bio companies seek to obtain, according to the company.

Based on the GRAS certification proving safety from the FDA, Bifido has been registering the Bifidobacterium bifidum BGN4 strain with the Chinese National Health Commission since 2019 to enter the probiotics market for infants and young children in China. The process takes a total of three years, and toxicological evaluation is currently underway. The company expects the registration with the Health Commission to be completed by the first half of 2022.

A company representative stated, “The safety of the BGN4 and BORI strains held by Bifido has been recognized by the U.S. FDA, and the effects of these strains on immune balancing within the human body continue to be revealed through various research papers. Through these effects, we are researching and developing treatments for various autoimmune diseases, and we expect the ongoing strain registration with the Chinese National Health Commission to proceed smoothly and be successfully completed.”