Chr. Hansen achieves first step Chinese approvals of 3 HMOs

Next in line is to pass the final nutrition fortifier approval process before market access is in place.

“This first Chinese regulatory approval of three of our HMOs is an important milestone in our quest to bring infant formula closer to breastmilk in China and our aim to market our HMOs to the world’s largest infant formula market. The approvals put us in a positive position to secure the final regulatory wins,” says Jesper Sig Mathiasen, senior vice president, Chr. Hansen HMO.

The 3-FL HMO 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.

The MARA approvals cover the technology to produce each of the three HMOs and it enables Chr. Hansen to apply for final approval of the 3 HMOs with Chinese authorities.

Chr. Hansen will also apply for Chinese approval of the remaining 2 HMOs in the clinically documented MyOliTM 5 HMO mix. The 5 HMOs in MyOli are already approved in the US and EU amongst others.

What are HMOs?
Human milk oligosaccharides (HMOs) are a major component of human milk, associated with multiple health benefits including shaping a healthy infant gut microbiome, possibly supporting brain development and the maintenance of a well-balanced immune system, reducing the risk of bacterial imbalance and maturing and maintaining the integrity of the intestine. Read more here.

What are the benefits of 2’-FL, LNT and 3-FL?
HMOs have been associated with a number of health benefits, including the 2’-FL, LNT and 3-FL:

  • 2’-FL: 2′-Fucosyllactose is the most abundant HMO in breast milk (Thum et al., 2021). It is known for its beneficial effect in immune development (Goehring et al., 2016), supporting a balanced microbiome composition (Hill et al., 2021) and positively associated with neurodevelopment (Berger et al., 2020).
  • LNT: Lacto-N-Tetraose, one of the most abundant HMOs in breast milk representing the group of basic neutral HMOs, contributes to the benefits of breastfeeding for infants and a well-balanced gut microbiome by helping to limit the growth of undesired microorganisms (Hill et al., 2021)
  • 3-FL: 3-Fucosyllactose increases in concentration over the course of lactation (Thum et al., 2021), and thereby becomes the most abundant HMO in human breast milk over time (Samuel et al., 2019; Thum et al., 2021).

For a more exhaustive overview see here.

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