The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administration (hereinafter referred to as NMPA).

At present, the upstream raw materials of biochemical reagents mainly rely on imports. For the long-term development of the industry, the preparation technology of raw materials must be mastered.

The reform of the distribution enterprises is imperative in the industrial chain, and the enterprises gradually begin to extend to service-oriented ones.

Building a complete biochemical testing system is the future development trend in the biochemical industry.

As an important reference for clinical diagnosis and treatment, high sensitivities and accuracies are very important for the control over the error of test results.

In terms of the pharmaceutical macro-political environment, the biomedical industry policies such as medical insurance cost control and target quantity procurement, are gradually implementing.

In 2019, the State Council successively promulgated three policy documents closely related to the biochemical analysis instruments and reagents, which laid an important policy foundation for the development of biochemical analysis instruments and reagents.

As companies developed with biochemical reagents, BSBE, Leadman, Medicalsystem, Maccura, Dirui, and Zybio are still flourishing in the biochemistry field; they are also developing new products and expanding into other areas based on the biochemical diagnosis while maintaining the existing biochemical product lines.

Zybio obtained the registration certificate and patent for the Lp-PLA2 assay kit (rate method) in 2015. The performance of the kit can reach the international leading level by using an innovative substrate design and reagent formula.

​Maccura obtained the registration certificate of this product and was granted the invention patent in 2018. It is the first creatinine assay kit for anti-drug interference.