Breaking News! The Fatty Liver Duo (CK18-M30/M65) Included in the "Standard for MAFLD Tiered Diagnosis and Treatment & Standardized Management Center Construction" — Hotgen Biotech Helps Bring the Standard to Practice

To implement the Healthy China strategy and address the pain points in the prevention and treatment of metabolic dysfunction-associated fatty liver disease (MAFLD/MASLD), the "MAFLD Tiered Diagnosis and Treatment & Standardized Management Center Construction Project" — guided by the Fatty Liver and Alcoholic Liver Disease Group of the Hepatology Branch of the Chinese Medical Association, and jointly initiated by the China Liver Health Promotion Center and the Hangzhou Aiyeqiao Medical Assistance Foundation — was officially launched yesterday at the Beijing Guoce International Conference and Exhibition Center. The conference brought together top hepatology experts from across the country for in-depth discussions on tiered diagnosis and treatment pathways, standardized center construction, clinical database integration, and multidisciplinary co-management strategies, marking a new stage of standardized and normalized fatty liver disease prevention and treatment in China. (Embedded photo in the original web page: the launch meeting)

■ Authoritative Standard Released: Building the "Four Pillars and Eight Beams" of Tiered Diagnosis and Treatment

At the launch meeting, Professor Rao Huiying of Peking University People's Hospital provided an in-depth interpretation of the "Standard for the Construction of MAFLD Tiered Diagnosis and Treatment and Standardized Management Centers." Developed jointly by authoritative hepatology experts in China, the standard defines a full-process closed loop of "primary-level screening — precise assessment at higher-level hospitals — tiered intervention and follow-up," and specifies the construction standards, multidisciplinary collaboration model, and quality control system for standardized management centers, providing a practical and replicable construction pathway for medical institutions at all levels nationwide.

 (Embedded photo in the original web page: Professor Rao Huiying, Peking University People's Hospital)

Notably, CK18 fragment testing has been written into this construction standard. The standard states: patients with suspected MAFLD/MASLD should undergo routine testing of serum alanine aminotransferase (ALT) and CK18 fragments (CK18-M30 and M65) to assess hepatocyte damage and apoptosis in steatohepatitis; for patients with clinically highly suspected steatohepatitis (MASH) complicated by metabolic syndrome/type 2 diabetes and with persistently elevated ALT or CK18 levels, hepatoprotective drugs may be considered to halt disease progression.

■ Multi-Stakeholder Collaboration to Tackle the Three Major Challenges in Fatty Liver Disease Prevention and Treatment

China's prevalence of metabolic dysfunction-associated fatty liver disease has exceeded 30%, making it the leading chronic liver disease. However, problems such as an underdeveloped diagnosis and treatment system, weak primary-level capacity, and fragmented data have long constrained prevention and treatment outcomes. This project launch proposes targeted solutions:

Standardized management center construction: building a nationwide specialty management network for fatty liver disease, promoting the tiered diagnosis and treatment model led by tertiary hospitals with collaboration from primary-level medical institutions, and achieving full-cycle patient management.

Digital platform empowerment: concurrently launching the construction of a national fatty liver clinical database platform, integrating multi-center diagnosis and treatment data to break down data silos and provide support for improving treatment quality and scientific innovation.

Multidisciplinary co-management system: promoting collaboration across gastroenterology, endocrinology, nutrition, cardiovascular, and other disciplines to resolve the clinical dilemma of systematic management of fatty liver comorbidities, achieving "co-treatment of heart and liver, co-management of metabolism."

■ Industry Innovation as an Enabler: Bringing Non-Invasive Diagnostic Technology Down to the Grassroots

Hotgen Biotech's CK18-M30/M65 chemiluminescence testing product is the first CK18 product in China to be assayed on a fully automated chemiluminescence platform. Leveraging its high sensitivity and high specificity, it provides a convenient and precise non-invasive assessment solution for steatohepatitis to medical institutions at all levels.

The release of this standard will promote the establishment of a unified national fatty liver disease prevention and treatment standard system, achieving full-process standardization of "prevention, screening, diagnosis, treatment, and management," and providing a solid safeguard for reducing the risk of fatty liver disease progressing to cirrhosis and liver cancer.