Japanese Ministry of Health, Labour and Welfare (Ministry of Health, Labour and Welfare) approve PreemieFort® as an enteral solution prescription NICU medical care

Duarte, California, February 19, 2026 /PRNewswire/ — Prolacta Bioscience® Japan’s Ministry of Health, Labor and Welfare (MHLW) today announced that it has approved Preemie Fort® Enteral Solution, a 100% human milk-based fortifier, for prescription for very low birth weight infants, infants with congenital gastrointestinal disease or congenital heart disease, and infants recovering from gastrointestinal surgery. This regulatory milestone was achieved in partnership with Clinigen Group, which acts as marketing authorization holder and distributor in Japan. PreemieFort is currently sold under the brand name “Humavant” outside of the United States, Canada, and Japan.

This landmark regulatory decision validates the critical role of Prolacta’s 100% human milk-based fortifier for the most vulnerable infants and sets a strong precedent for neonatal intensive care units (NICUs) around the world.

“Prime Fort’s approval as a prescription drug in Japan reflects the strength of our clinical evidence and pharmaceutical-grade processing, which withstands Japan’s stringent regulatory and quality requirements,” said Scott Elster, CEO of Prolacta Biosciences. “This pivotal Japanese clinical study adds to the extensive body of evidence supporting the benefits of Prolacta’s unique human milk-based diet for critically ill and vulnerable premature infants.”

Clinical evidence obtained in Japan from the JASMINE trial (“Randomized Controlled Study to Evaluate Growth and Safety of Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants”) influenced Japan’s world-class Pharmaceuticals and Medical Devices Agency (PMDA) review. A Japanese-led, phase III, randomized, controlled, open-label, multicenter trial evaluated the growth and safety associated with Prolacta’s 100% human milk-based fortifier and demonstrated significantly better growth in VLBW infants, with no change in morbidity or mortality.

Japan is recognized as a world leader in neonatal care, with one of the highest early survival rates and one of the lowest rates of necrotizing enterocolitis (NEC).^1,2 A life-threatening intestinal disease that primarily affects premature infants. By granting PreemieFort regulatory approval, Japan confirms that Prolacta’s milk-free breast milk-based fortifier is not just a nutritional option, but an Rx drug in the NICU.

Japanese approval includes three Prolacta products — Primy Fort Enteral Liquid 6, Primy Fort Enteral Liquid 8 (Humavant +6 and Humanavant +8 breast milk-based fortifiers outside the US, Canada, and Japan), and Primy Fort Enteral Solution CF (Humavant CR Breastmilk Calorie Fortifier, outside the US, Canada, Japan) – Provides intensive nutrition that supports growth by providing essential calories and nutrients while maintaining the highest levels of human milk bioactivity.

This approval demonstrates clinical confidence in the benefits and safety of PreemieFort breast milk-based fortifier for a wide range of vulnerable infants with complex nutritional needs.

“In the NICU, what you give to the smallest patient can have an impact on that patient’s entire life,” said Kate Tauber, MD, professor of pediatrics and director of the lactation program at Bernard Millie Duker Children’s Hospital. “Breast-based fortifiers have the same expectations as any other treatment: they must be consistent, tightly controlled, and safe. Prolacta’s commitment to pharmaceutical-quality manufacturing requirements will help protect vulnerable infants and support better outcomes.”

Prolacta maintains the industry’s most stringent quality and safety standards for screening, testing and processing donor milk. This standard extends to the manufacture of pharmaceutical grade products. These controls have resulted in prescription drug approval in Japan, one of the highest regulatory benchmarks in the world.

About Prolacta Bioscience
Prolacta Bioscience® is a world leader in human milk-based nutrition and is dedicated to improving the health of critically ill and premature infants. The company’s 100% human milk-based fortifiers and formulas are used by more than 125,000 vulnerable premature infants worldwide.³ In a world first, Japan has granted Prolacta PreemieFort® fortifier prescription drug status in late 2025 for very low birth weight infants, infants with congenital gastrointestinal disease or congenital heart disease, and infants recovering from gastrointestinal surgery. Prolacta operates a pharmaceutical-grade human milk processing facility and maintains the most stringent quality and safety standards in the industry, including more than 20 tests to screen donor milk and the use of vat pasteurization to inactivate pathogens and ensure safety. Vat pasteurization also preserves the biologically active components of breast milk that support immune protection, gastrointestinal development, and growth. This is an especially important benefit for premature and medically fragile infants.^4-6 Vat pasteurization brings breast milk closer to its natural state than other processing methods, while ensuring safety. Prolacta has built a safe, independent donor milk supply chain backed by long-term partnerships with thousands of rigorously vetted donors to ensure sufficient supply to meet NICU demands. Prolacta’s products have been evaluated in more than 30 peer-reviewed clinical studies, demonstrating the short- and long-term health benefits of its patented breast milk-based fortifiers and formulas. learn more online or in ×, Instagram, facebook, TikTokand linkedin.

Media contact:
Lauren Cosmont
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310-721-9444

References

1. Kusuda S, Bennett MV, Gould JB et al. Comparative analysis of necrotizing enterocolitis in preterm infants born in Japan and preterm infants born to mothers of Japanese ancestry in California. Sci Rep. 2025;15:9943. doi:10.1038/s41598-025-92393-y
2. Isayama T. Clinical management and outcomes of very preterm infants in Japan: past, present, and future. Translation Pediatrics. 2019;8(3):199-211. doi:10.21037/tp.2019.07.10
3. Data on file. Estimated number of premature infants given Prolacta products from January 2007 to May 2025.
4. Ozturk G, Paviani B, Rai R et al. Investigating the structure, size, and function of milk fat globules after heat treatment and homogenization of human milk. food. 2024;13(8):1242. doi:10.3390/food13081242
5. Liang N, Koh J, Kim BJ et al. Changes in structure and function of bioactive proteins in donor human milk processed by vat sterilization, retort sterilization, ultra-high temperature sterilization, freeze-thaw and homogenization. front nut. Published online on September 15, 2022. doi:10.3389/fnut.2022.926814
6. Meredith-Dennis L, Xu G, Goonatileke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and changes in macronutrients, immune proteins, and human milk oligosaccharides in human milk from non-commercial and commercial milk banks. J. Ham Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635

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Source Prolacta Bioscience