Regulatory achievement: Gnosis’ Quatrefolic fortification substance authorized in China

08 Nov 2017 --- Biotechnology company Gnosis’ Quatrefolic compound has been publicly authorized in China as a Food Nutritional Fortification Substance. The compound now has a specific monograph that describes its quality (physical, chemical and microbiological) requirements.

Gnosis reports that thanks to an official notification (2017, No. 8) issued on October 20, 2017 by the National Health and Family Planning Commission of the People’s Republic of China (the former Ministry of Health of the People’s Republic of China), Quatrefolic is now recognized as complying with the country’s Food Safety Law.

The first positive assessment was made by the China National Center for Food Safety Risk assessment (CFSA) in early 2016. Quatrefolic is now a nutritional fortification substance in China.

The published monograph defines dosage and intended use of Quatrefolic, the 5-MTHF glucosamine salt, as a new active ingredient, introducing the option of the innovative folate instead of the already well-known folic acid. The official publication can be found here.

Quatrefolic is a metabolically active folate that is not affected by the common impairments of folate metabolism since it does not require the complex absorption, metabolic and enzymatic steps that are required by folic acid, Gnosis notes. Contrary to folic acid, Quatrefolic – being the metabolically active form of folic acid – is not influenced by the polymorphism of the MTHFR (methyltetrahydrofolate reductase) enzyme, a genetic defect with a high level of incidence in the Chinese population.

In these parts of the population, folic acid is not effectively converted to the biologically active form 5-MTHF (methylfolate) due to reduced enzymatic activity. The beneficial effect of folic acid supplementation is therefore not guaranteed in those with folate deficiencies, a group which includes many in China.

Focus on Chinese incidence of MTHFR polymorphism
In recent years, Gnosis has observed that a multitude of clinical studies have investigated the incidence of this polymorphism in China. Of particular relevance, the very recent meta-analysis published in 2016 by Wang et al. – where 66 studies were identified with a total of 92,277 study participants in 23 provinces in Mainland China – is cited by the company.

The meta-analysis revealed that the frequencies of the MTHFR C677T allele and the 677TT genotype increased from lower values (5 percent and 17 percent, respectively) in Guangxi in the South, to intermediate values (12 percent and 32 percent, respectively) in Anhui in the East, to higher values (39 percent and 62 percent, respectively) in Shandong in the East.

The frequency of the 1298C allele was found to be the lowest in Northern China (around 18 percent), intermediate in Central China and highest in southern China (around 28 percent). The mean frequency of the 1298C allele was around 20 percent.

The study, “Geographical and Ethnic Distributions of the MTHFR C677T, A1298C and MTRR A66G Gene Polymorphisms in Chinese Populations: A Meta-Analysis,” can be found here.