Last month, Hong Kong-headquartered H&H Group launched its first HMO infant formula in Mainland China following the implementation of China’s new national (Guobiao or GB) standards.
Launched under its baby nutrition brand Biostime, the product made in France contains six HMOs, including 2′-fucosyllactose (2′-FL) at a higher dose of 1620mg per 100g, 3′-galactosyllactose (3′-GL), 4′-GL, 6′-GL, 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL).
The company’s infant formula sales in Mainland China jumped 74.4% in Q1 this year. Including other regions, revenue for H&H Group’s infant formula business was RMB$1.55bn (US$226.5m), up 71.8% from the same period last year.
The company said in its 2026 Q1 results that it expected the HMO innovation to be a key long-term growth driver for Biostime, especially in the super-premium category.
Mike Peng, baby nutrition and care CEO for China at H&H Group, said that HMOs, unlike other functional ingredients, have become the core in infant formula innovation. This is because HMOs are the third-most abundant solid component in breast milk and recent regulatory approvals have increased their use in infant nutrition.
“In recent years, with the release of China’s new GB standards, the era of ‘comprehensive breastfeeding’ for infant milk formula has begun. As the key active ingredient in breast milk, HMO is also the third-most abundant solid component in breast milk; it has become the core of formula innovation, which is different from OPO and other functional ingredients that focus on absorption and digestion,” Peng said in response to NutraIngredients’ queries.
Three HMOs are approved for use in infant formulas in Mainland China so far, namely 2′-FL, lacto-N-neotetraose (LNnT) and 3’-SL, which was only approved in February this year.
Regulatory approvals of HMOs have been the driver of new launches in infant nutrition products, said Annette Lau – Global Regulatory Affairs Senior Manager ELN & MN at dsm-firmenich.
She pointed out that in 2024, regulatory approvals of HMOs have accounted for up to 28% of new formulas entering the global market.
“In China specifically, with the inaugural approval of 2’-FL and LNnT in October 2023, there has been a remarkable uptick in HMO suppliers, and the development of competitive HMO-containing products has become a premiumization and expansion lever in the market,” she said.
HMO infant formulas are also moving from single or dual-HMO to using three or more HMOs in the formulation. In Vietnam, for example, local dairy giant Vinamilk launched the country’s first six-HMO infant formula last year.
“The sequential approvals have also enabled a global shift towards better representation of the complex composition of breastmilk, from single HMO novelties to increasing penetration of five- to seven-HMO recipes that better recapitulate the structural and functional diversity of HMOs in human milk,” said Lau.
Aside from Mainland China, HMO approvals were also granted in Malaysia and Thailand recently.
Malaysian authorities, for example, have approved four HMOs from dsm-firmenich as optional ingredients in infant formula, follow-on formula, and formulated milk powder for children in January this year. They include the 3’-SL sodium salt, as well as 2FL/DFL, Lacto-N-Tetraose (LNT) and 6’-SL sodium salt.
In Thailand, dsm-firmenich also secured approvals for 2’-FL/difucosyllactose (DFL), LNT, 3’-SL, and 6’-SL last year.
Moving beyond premium categories
As the number of HMOs approved for use in infant nutrition increases, Lau believes that HMO-containing infant formulas would become more affordable.
“Today, HMOs are still predominantly found in premium formula segments, but as regulatory frameworks mature and production scales, there is a clear expectation that HMO fortification will move into mid‑tier and more affordable segments," she said.
This shift, she said, would be supported by rising parental awareness of HMOs, particularly in Asian markets, where caregivers increasingly associate HMOs with gut health, immunity and overall developmental benefits.
Formulation, not just addition
At the same time, Peng emphasized that competition in the infant milk formula space is not simply about the use of HMOs alone, but the overall formulation.
“H&H believes that competition in infant milk formula has never been about the comparison of ‘single ingredient’, but rather about ‘ingredient formulation’,” he said. “Other ingredients like OPO play an important role in optimizing nutrient absorption and protecting intestinal health, while HMOs focus on regulating intestinal flora, enhancing immune function and supporting overall development, forming a complementary synergy with other ingredients,” he said.
Lau added that there has been growing research into the nutritional benefits of increasingly complex blends of HMOs, which could, in turn, fuel further interest in HMOs among regulators.
“This has enabled dialogue with regulators and deep dives into the incremental and biologically distinct roles of the different structural classes of HMOs and the mechanisms of action that better demonstrate why combinations of HMOs play an important supportive function in the infant gut microbiome and immune development, among other outcomes.”
