Inbiose achieves full regulatory approval in China for its human milk olichosaccharide 2'FL

Ghent Belgium – 12 December, 2023

Inbiose, a leading biotech company active in the development of Human Milk Oligosaccharides

(HMOs), is pleased to announce that it has received full regulatory approval for its 2’‐fucosyllactose (2’‐FL) in China by the ministries of health and agriculture. 2’‐FL is the main HMO in mother’s milk and has been approved for use in four food categories: infant formula, formula for elder infants and young children, infant formula for special medical purposes, and formulated milk powder at a usage level from 0.7 to 2.4 g/L.

Human milk oligosaccharides protect babies from infection and inflammation, promotes the development of immunity, promotes healthy bacteria in the gut and positively affects brain development. It is estimated that more than 100 different HMO structures are present in human milk. Recently Inbiose obtained also clearance for 6 HMOs in the US as one of the few companies in the world.

“We are very excited about this big milestone for Inbiose. I am very proud of our team that has allowed us to achieve this breakthrough into the Chinese market. It will help Inbiose to grow even faster and to bring our innovative Human Milk Oligosaccharides also to the Asian market” said Prof. Wim Soetaert, executive chairman of Inbiose.

Inbiose has been developing a wide range of Human Milk Oligosaccharides that are structurally identical to the ones from human milk and can be industrially produced by sustainable fermentation processes at low cost. Inbiose is currently developing its next generation HMOs that will permit infant formula milk with an HMO composition that is close to breast milk. HMOs are the newest ingredients for premium infant formula and industry watchers expect the HMO market to reach €500m by 2025 with an annual growth of 20 to 30%, growing further to well over € 1bn. The markets for HMOs go beyond infant nutrition as recent scientific studies have demonstrated that HMOs may play an important role as bio‐active health ingredients for improved immunity, gut and brain health of the general population.

About Inbiose

Inbiose is a Belgium‐based biotech company focused on the research, development and commercialization of specialty carbohydrates, including human milk oligosaccharides (HMOs). Inbiose’s unique proprietary technology platform “GlycoActives^®” enables cost‐effective manufacturing of a wide range of specialty carbohydrates by sustainable fermentation processes. Since its establishment in 2013, Inbiose has grown to a dedicated team of over 50 people, unlocking the vast potential of specialty carbohydrates for a wide range of human and animal health applications.

For more information, please visit www.inbiose.com or send an e‐mail to busdev@inbiose.com