November 28, 2025, Lianyungang — The National Health Commission officially approved on November 27 the application of "Magnafolate" (Crystalline Form C 6S-5-methyltetrahydrofolate calcium), developed by Lianyungang Jinkang Hexin Pharmaceutical Co., Ltd., as a food nutrient fortifier in wheat flour. This breakthrough signifies a major advancement for China's active folate technology in the field of staple food fortification, providing consumers with a safer and more efficient folate supplementation solution.

Major Breakthrough in Application: Magnafolate Expands from Specific Populations to Mass Staple Food

Jinkang Hexin initiated the application process for using 6S-5-methyltetrahydrofolate calcium in wheat flour in March 2025. After eight months of rigorous review, formal approval was granted by the National Health Commission on November 19, 2025, and announced publicly on November 27 via the "Announcement on 14 'Three New Foods' Including Venetian Fusarium Protein (2025, No. 7)."

This approval marks a significant upgrade in Magnafolate's application scope. Building upon its 2021 approval for nutritional supplementation in pregnant and lactating women, it has now successfully expanded to wheat flour—a staple food consumed by the general population. This represents a strategic shift from targeted supplementation for specific groups to nationwide nutritional fortification, opening a new chapter for staple food nutrition in China.

Technical Breakthrough: Patented Crystalline Form C Magnafolate Sets New Industry Benchmark

Jinkang Hexin's "Magnafolate" utilizes proprietary patented Crystalline Form C technology, achieving comprehensive breakthroughs in stability, bioavailability, and safety, providing a technologically advanced solution for flour nutrition fortification.

1. Crystalline Stability Advantage: The Crystalline Form C structure demonstrates excellent thermal and chemical stability. It maintains over 98% activity under the high-temperature conditions of flour processing, effectively preventing nutrient loss due to heat and light exposure during production, ensuring stable folate levels in the final product.
2. Bioavailability Advantage: As the direct active form of folate, it can be absorbed and utilized directly by the body without the complex MTHFR enzyme metabolic pathway required by folic acid. Its bioavailability is significantly higher than ordinary folic acid. This is particularly beneficial for the 78.4% of the Chinese population estimated to have folate metabolism impairments, offering a more efficient and safer folate supplementation option.
3. Product Purity Advantage: Utilizing globally patented technology, Jinkang Hexin ensures the purity of the Crystalline Form C product exceeds 99.8%. The control limit for the key harmful impurity JK12A is only one-tenth of the United States Pharmacopeia standard. Authoritative testing by the Shanghai Center for Disease Control and Prevention certifies Magnafolate as practically non-toxic, providing reliable safety assurance for food applications.

According to the draft "National Food Safety Standard for the Use of Food Nutrition Fortifiers" issued by the National Health Commission, wheat flour is identified as a key carrier for mass food fortification, with a recommended folate addition level of 1000-3000 μg/kg. The inclusion of "Magnafolate" will provide flour producers with a superior choice for nutritional enhancement.

Broad Market Prospects: Trillion-RMB Staple Food Market Embraces New Nutrition Upgrade Opportunity

Industry data indicates China's annual wheat flour consumption reached 81 million tons in 2024, representing a vast and steadily growing market. With rising consumer health awareness, nutritionally fortified wheat flour is entering a period of rapid development.

As a mainstream government-promoted fortification strategy, the "7+1" nutrient fortification formula is widely implemented across China. The integration of Magnafolate represents a technological upgrade. Its superior stability and high bioavailability can significantly enhance the actual nutritional effectiveness of fortified flour, offering flour producers more competitive product differentiation options and driving the industry towards more efficient and precise nutritional fortification.

Significant Social Value: Staple Food Fortification Supports the "Healthy China" Strategy

Folate, a crucial B vitamin, plays an irreplaceable role in preventing neonatal neural tube defects and reducing the risk of cardiovascular diseases. Fortifying wheat flour, a daily staple food, with folate enables low-cost, wide-coverage nutritional intervention. This approach particularly benefits special populations like women of childbearing age and the elderly, effectively improving the overall health level of the nation.

A representative from Jinkang Hexin emphasized: "The approval of Magnafolate for wheat flour application is a concrete action by our company in implementing the 'Healthy China' strategy. From raw material R&D to the application process, we consistently adhere to the highest quality standards. The breakthrough in Crystalline Form C technology not only enhances product performance but also establishes a new technical benchmark for the industry. We will continue to innovate and contribute more technological achievements to national nutrition and health."

This innovative application will propel staple food nutrition fortification into a new phase, providing crucial technical support for achieving universal health coverage.

About Jinkang Hexin: A Leader in Active Folate Technology

Lianyungang Jinkang Hexin Pharmaceutical Co., Ltd., a pioneer and benchmark in China's active folate technology, has focused on the research, development, and industrialization of naturalized folate for 18 years. The company has built the world's largest patent portfolio for active folate technology, holding 42 global invention patents, and has established a comprehensive intellectual property protection system.

Since successfully promoting "Magnafolate" as a new folate fortification source in 2017, Jinkang Hexin has continuously led industry technological upgrades, facilitating the application of active folate in key areas such as foods for special medical purposes, maternal and infant formula, and special dietary foods. The company has built a full industrial chain technology platform encompassing core raw material R&D, process innovation, and application solutions, providing the food industry with high-quality nutritional fortification options that meet regulatory requirements.

With 18 years of dedicated technological development, Jinkang Hexin has become a technical authority and standard-setting participant in China's active folate field, continuously contributing to the "Healthy China" strategy through technological innovation and promoting the improvement of national nutrition and health levels.

References:

[1] National Health Commission of the People's Republic of China. Announcement on 14 "Three New Foods" Including Venetian Fusarium Protein (2025, No. 7).

[2] Lian, Z., Liu, K., Gu, J., Cheng, Y., et al. Biological Characteristics and Applications of Folate and 5-Methyltetrahydrofolate. China Food Additives, 2022, (2).

[3] Ma, W., Xue, J., Tu, H., Liu, K., Cheng, Y., Lian, Z., et al. Edible Safety Evaluation of 6S-5-Methyltetrahydrofolate Calcium. Frontiers of Medicine, 2022, 12(15).

[4] Xu, T., Wang, K., Zhang, J., et al. Study on the Characterization of 6S-5-Methyltetrahydrofolate Calcium Salt Crystal Form C and its Stability Improvement by Ascorbic Acid and Cysteine. LWT - Food Science and Technology, 2024, 198: 115984.

[5] Wang, Y., Lian, Z., Gu, R., et al. Oxidation Product of 5-Methyltetrahydrofolate: Structure Elucidation, Synthesis, and Biological Safety Evaluation. Journal of Molecular Structure, 2024, 1316: 138909.

[6] Lian, Z., Chen, H., Liu, K., et al. Improved Stability of a Stable Crystal Form C of 6S-5-Methyltetrahydrofolate Calcium Salt, Method Development and Validation of an LC–MS/MS Method for Rat Pharmacokinetic Comparison. Molecules, 2021, 26, 6011