Synaura's 2'-FL (2'-fucosyllactose) received approval from the National Health Commission this October, making it among the first domestically produced HMOs to gain authorisation in China. Multiple media outlets have hailed it as ‘China's dark horse that has resolved the bottleneck caused by Western technology’.

In fact, as early as 2022, Synaura had already begun expandingoverseas markets. This June, it conducted a self-GRAS scientific evaluation in accordance with the U.S. FDA's Generally Recognised as Safe (GRAS) guidelines and received expert approval.

Synaura Biotech ExpandsInternational Markets

Synaura Biotech has secured U.S. self-GRAS market access approval, formally entering the international market.

Synaura's 2'-FL successfully obtained US FDA self-GRAS market access approval on 1 June 2023, marking a milestone achievement as the first instance of a Chinese enterprise securing global market access in the HMO sector through proprietary intellectual property. Concurrently, the company's independently developed 2'-FL (2'-fucosyllactose) has submitted safety certification applications to regulatory authorities across multiple countries worldwide. The attainment of self-GRAS safety certification signifies Synaura's HMOs have entered the international arena, establishing them as a globally recognised emblem of Chinese manufacturing.

Awarded multiple titles as ‘China's Local Market Leader’

Synaura, as a homegrown emerging raw materials enterprise in China, has claimed multiple ‘firsts’ in the domestic market, emerging as a formidable new force with remarkable momentum and garnering significant attention for its capabilities. Its core product, HMO, has secured numerous top accolades, propelling its unstoppable rise.

The Scientific Consensus on Human Milk Oligosaccharides (HMOs) was formally published in the Chinese Journal of Food Science, with Synaura becoming the first Chinese HMO raw material enterprise to participate in this authoritative release.

As the leading domestic HMO enterprise in China, Synaura possesses formidable development potential while also bearing the significant responsibility and commitment to spearhead innovation as a local company.

Synaura HMO Exceptional Performance

Scientifically validated, Synaura Biotech's HMO products exhibit identical structural composition to human milk oligosaccharides extracted from Chinese mothers' breast milk. HMO (human milk oligosaccharides) delivers significant benefits across three key areas: maintaining gut health, enhancing the immune system, and boosting cognitive development.

In maintaining gut health, HMOs can repair the intestinal barrier, improve the gut microbiota micro-ecology, and alleviate intestinal disorders;

In enhancing the immune system, HMOs promote immune system maturation, resist pathogen invasion, and mitigate allergic reactions;

In boosting cognitive abilities, HMOs have demonstrated remarkable efficacy in promoting brain development and enhancing learning and memory capacities.

Clinical studies indicate that HMO supplementation increases bifidobacteria levels in infant gut flora, reduces the incidence of lower respiratory tract infections and otitis media, and decreases reliance on antipyretics and antibiotics. For adults, HMOs demonstrate efficacy in alleviating symptoms of irritable bowel syndrome and ulcerative colitis.

Synaura's 2'-FL has achieved dual certification as self-GRAS in the U.S. and by China's National Health Commission, marking a groundbreaking milestone in HMO research and application. Moving forward, the company will continue to deepen innovative researchbioactive components such as human milk oligosaccharides, actively expanding the boundaries of scientific research categories while strategically positioning itself in other health sectors. This approach aims to achieve the organic integration of scientific research with industrialisation of outcomes.

Synaura Biotech is committed to championing domestic innovation, driving the vigorous advancement of indigenous biosynthetic technologies, and propelling China to become a flagship leader in the Fourth Industrial Revolution.