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New Chinese review step achieved for Novonesis HMOs

Mrz 07. 2024 12:24 GTM

All five single HMOs of Novonesis’ (previously Chr. Hansen) clinically documented 5 mix solution, passed the biosafety review by the Chinese Ministry of Agriculture and Rural Affairs (MARA).   

Novonesis, the new company following the merger between Chr. Hansen and Novozymes on January 29, 2024, is pleased to announce the passing of the biosafety review by MARA, of its GMM dossiers for the two HMOs, 3 '- SL and 6' - SL

As announced in September 2023, the other 3 HMOs (2’-FL, LNT, 3-FL) of the clinical documented MyOli® 5 HMO mix from Novonesis reached this step previously. These 3 HMOs are already in the last stage, the nutrition fortifier approval. 

Therefore, now all five MyOli® HMOs (2’-FL, LNT, 3-FL, 3’-SL and 6’- SL) are in a good path to readiness for Chinese infant formula applications, and this allows infant formula players present in China to accelerate their formula innovation to a higher degree, of 5 HMOs. 

“Passing the biosafety review, also for 3'-SL and 6'-SL is an important step forward towards bringing the Novonesis HMO blend of 5 HMOs into infant formula products in China. Some of their documented benefits show a support of the development of the immune system and shaping the gut microbiome” says Anna Przewozna, Head of Commercial at Novonesis HMO division. 

“The 3-FL, part of those HMOs, is particularly interesting for Chinese consumers as empirical studies of Chinese mothers’ breastmilk have shown a 3-FL concentration increase in the first months and hereafter maintaining a high level during the period of lactation.” explains Dr. Yannik Schönknecht, Scientific Advisor at Novonesis HMO division.   


What are HMOs? 
Human milk oligosaccharides (HMOs) are a major component of human milk, associated with multiple health benefits. This includes shaping a healthy infant gut microbiome, possibly supporting brain development reducing the risk of bacterial imbalance, and contributing to maintenance of the immune system, and integrity of the intestine. 


What are the benefits of 3'-SL and 6'-SL? 

  • 3'-SL: 3'-sialyllactose (3'-SL) is a major sialylated HMO. Scientifically, it is of interest because of its lactation role. 3'-SL concentrations in human milk were shown to be mostly stable over the course of lactation, whereas that of most other HMOs declines (Thum et al. 2021). Along with other HMOs, 3'-SL is involved in the development of the brain, cognitive functions, and immunity (Fan et al. 2023, Triantis et al. 2018).  

  • 6'-SL: 6'-sialyllactose represents a sialylated HMO, which contains sialic acid as a building block. Sialic acid is a building block for brain and nerve cells, being especially relevant in early life for proper brain development. 6'-SL is of special interest as it represents the most abundant sialylated HMO structure in human milk (Wang et al. 2012).  

Find a more exhaustive overview of Novonesis’ HMO portfolio

Novonesis supports the recommendation of the World Health Organization (WHO) towards breastfeeding exclusively for the first six months, followed by continued breastfeeding together with complementary foods.


About Novonesis 

Novonesis is a global company leading the era of biosolutions. By leveraging the power of microbiology with science, we transform the way the world produces, consumes and lives. In more than 30 industries, our biosolutions are already creating value for thousands of customers and benefiting the planet. Our 10,000 people worldwide work closely with our partners and customers to transform business with biology.



Let’s better our world with biology.


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