Big news! Chenyu Taikang has successfully obtained the production license for Class II reagents and established an integrated solution for precise diagnosis

Big news! Chenyu Taikang has successfully obtained the production license for Class II reagents and established an integrated solution for precise diagnosis

This marks that the company has officially acquired the capacity for large-scale production of diagnostic reagents and achieved a dual-wheel drive strategic layout of "instruments + reagents";

On November 14, 2025, Chenyu Jiakang Biology, a subsidiary of Chenyu Taikang Group, officially obtained the "Medical Device Production License" issued by the Jilin Provincial Drug Administration. The production scope covers Class II: 6840- in vitro diagnostic reagents. This heavy license is not only a high-level certification of the company's quality management system and production capacity, but also marks that the company has successfully bridged the "last mile" from research and development to industrialization, officially entering the field of in vitro diagnostic (IVD) reagent production, and setting another important milestone in the company's development history.

Break through the barriers of high requirements and consolidate the foundation of industrialization

In vitro diagnostic reagents, as an important basis for disease prevention, diagnosis and treatment, their quality directly concerns the life safety of patients. According to the "Regulations on the Supervision and Administration of Medical Devices"; of the state, Class II medical devices have medium risks and need to be strictly controlled and managed. The acquisition of its production qualifications sets extremely high thresholds for the enterprise's quality system, production environment, equipment, process flow and personnel capabilities. This successful certification indicates that the company has established a mature and stable quality management system that fully complies with the "Good Manufacturing Practice for Medical Devices" (GMP for Medical Devices). From raw material procurement, production processes to product inspection, release and storage, every link has been standardized, refined and traceable, ensuring that all reagent products leaving the factory in the future can maintain excellent stability and accuracy.

         

Accurately layout new tracks and strengthen collaborative competitiveness

This certification has completed a crucial piece of the puzzle in the company's product portfolio. The first batch of approved and soon-to-mass-produced prothrombin time assay kits (coagulation method) - PT and activated partial thromboplastin time assay kits (coagulation method) - APTT and other series of products will precisely serve the vast market including clinical emergency departments, icus, primary medical institutions and health check-ups.

Most importantly, these self-produced reagents will form a powerful "instrument + reagent" closed-loop ecosystem with the company's core product line - coagulation analyzer equipment. This not only provides customers with a more complete and economical integrated solution, greatly enhancing customer stickiness, but also builds a core competitive barrier that is difficult for the company to replicate, achieving a strategic upgrade from an equipment provider to a comprehensive diagnostic solution partner.

Steady progress leads to a long-term vision, safeguarding life and health with "Made in China";

This production license is not only an acknowledgement but also a heavy responsibility, marking a new chapter for the company. In the future, the company will take this as a foundation. On the one hand, it will strictly adhere to the relevant quality standards and requirements to ensure that every reagent is accurate and reliable. On the other hand, we will further accelerate the industrialization process of our diagnostic reagent research and development projects, continuously enrich our product menu, and be committed to providing more high-quality ";Made in China" diagnostic products for people's health and well-being, contributing our strength to the "Healthy China" strategy.