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New Breakthrough in Nattokinase Research: A Leap from Laboratory to Clinical Application

2025-10-24

Global Scientific Forces Focus on New Pathways for Cardiovascular and Cerebrovascular Disease Prevention and Control

 

October 23, 2025, Beijing (Xi'an)

As the global burden of cardiovascular and cerebrovascular diseases continues to increase, the scientific research value of nattokinase as a natural thrombolytic substance is becoming increasingly prominent. Recently, multiple authoritative institutions worldwide have propelled the application of nattokinase in disease prevention and health management into a new stage through basic research, clinical validation, and technological innovation.

Clinical Studies Confirm Dual Efficacy in Thrombolysis and Blood Pressure Reduction

A long-term clinical study conducted by the Japan Bio Science Institute and St. Marianna University School of Medicine showed that NSKSD nattokinase can significantly inhibit platelet aggregation and reduce the risk of thrombosis. Since its initial publication in 2003, these findings have been validated through over twenty human clinical trials, with its safety and efficacy gaining international recognition. Further research discovered that nattokinase exhibits potential in combating vascular inflammation by enhancing NK cell activity and improving microcirculation.

Validation in Chinese Population: Clinical trials at Hangzhou First People's Hospital showed that a daily dose of 8000 FU could improve cerebral blood supply in high-risk populations for cardiovascular and cerebrovascular diseases, with 46.7% of subjects showing regression of carotid artery plaques. A 6-year study (3,471 cases) at Barcelona Hospital in Spain further confirmed that nattokinase combined with lifestyle interventions could lead to the regression of carotid artery plaques in 8% of cases.

Technological Innovation Overcomes Stability Challenges

Addressing the stability issues of nattokinase in the gastrointestinal environment, Professor Du Ming's team at Dalian Polytechnic University developed functional delivery carriers based on polysaccharides and proteins. Using a double-embedding technology, this carrier significantly extends the half-life of nattokinase and effectively preserves its core thrombolytic activity. The research points out that nattokinase, as an alkaline serine protease, has advantages such as small molecular weight, high specificity, and low risk of causing bleeding, providing new ideas for the development of oral thrombolytic products.

Technological Breakthroughs:

Primary Embedding: Small molecule protein peptides protect the enzyme's active center from gastric acid destruction.

Secondary Embedding: Cellulose enhances heat resistance, with activity retention rate >95% at 60°C.

Application Effects: Enteric-coated tablets retained 95% activity after 2 years of storage at room temperature; colon-specific sustained-release capsules achieved targeted release.

Typical Cases:

Microencapsulation Process: Using nano-scale protective capsules increased bioavailability by 40%.

Combined Intervention Scheme: Nattokinase combined with Vitamin K2 synergistically inhibits vascular calcification and reverses arteriosclerosis.

 Market Dynamics: Global Scale and Regional Growth

According to the latest industry report, the global nattokinase market size is projected to reach $1.23 billion in 2025, with a compound annual growth rate (CAGR) of 10.2%. The main drivers of market growth include:

Increasing Burden of Cardiovascular Diseases: Over 500 million patients globally with cardiovascular and cerebrovascular diseases drive demand for preventive health products.

Asian Market Boom: Countries like China, Japan, and South Korea, due to aging populations and rising health awareness, are the fastest-growing regions.

Accelerated Industrial Innovation: Companies are expanding application scenarios through technological upgrades (e.g., nano-delivery systems) and developing combined formulations (e.g., nattokinase + Vitamin K2).

Competitive Landscape:

Japanese Companies Dominate: Brands like NSKSD nattokinase hold over 60% of the global market share.

Rise of Chinese Companies: Domestic companies are accelerating international layout through technological innovation (e.g., microencapsulation) and cost advantages.

Policy Support: China has included nattokinase in the "Healthy China 2030" plan, promoting industrial standardization.

Future Prospects: Precision Nutrition and Global Collaboration

In September 2025, the 17th National Congress of Nutritional Sciences, themed "Nutritional Innovation Promotes High-Quality Development of National Health," listed nattokinase research as a key direction. Experts pointed out that future efforts need to deepen research on the synergistic mechanisms of nattokinase and Vitamin K2 and establish internationally unified efficacy evaluation standards. With the advancement of the "Healthy China" strategy, nattokinase is expected to become an important option for the primary prevention of cardiovascular and cerebrovascular diseases.

 

Remarks:

Clinical study by Japan Bio Science Institute and St. Marianna University School of Medicine (2003-2025)

Research on functional delivery carriers by Professor Du Ming's team at Dalian Polytechnic University (2024)

Clinical data from Hangzhou First People's Hospital (2023-2025)

Nattokinase Sub-forum at the 17th National Congress of Nutritional Sciences (2025)

Global nattokinase market size and growth data (2025-2031)

 

 

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