In today's rapidly developing pharmaceutical industry, reference reagents are playing an unprecedentedly important role as key benchmarks for drug development, quality control, and clinical trials. Recently, a series of innovative achievements and industry changes related to reference reagents are reshaping the pattern of pharmaceutical research and development, attracting widespread attention.

The demand for high-quality reference reagents continues to rise among many internationally renowned pharmaceutical companies in the development of complex innovative drugs. According to data from Yaozhi, the total sales revenue of the biopharmaceutical market in 2023 exceeded 160 billion yuan, with a year-on-year growth of 11.86%. It includes 368 varieties from 280 enterprises, with an average sales revenue of about 450 million yuan per variety. In the development process of biosimilar drugs, reference reagents not only ensure drug efficacy and safety, but also become a core element to accelerate the research and development process and reduce research and development costs. For example, the Neupogen biosimilar drug from American company Amgen used high-quality reference reagents in the research and development process, successfully shortening the research and development cycle by about 20% and saving research and development costs by about 15%. The development and application of new reference reagents, such as high stability reference reagents based on new materials, provide more accurate and reliable solutions for drug quality control, effectively addressing the challenges of complex drug component analysis and quality standard formulation.

Domestic pharmaceutical companies have deepened their dependence on reference reagents in the promotion of generic drug consistency evaluation. With the increasing competitiveness of the generic drug market, companies are paying more attention to the selection and use of reference reagents to ensure that product quality is highly consistent with the original drug. According to data from MiNet, the number of drugs in China that have passed the consistency evaluation of generic drugs will increase by 30% year-on-year in 2023, with the quality and applicability of reference reagents becoming key factors. For example, Jiangsu Hengrui Pharmaceutical selected high-quality reference reagents in the consistency evaluation of a certain anti-tumor generic drug, which enabled the product to pass the evaluation smoothly and increased its market share to 35%. The cooperation mode between reference reagent suppliers and pharmaceutical companies continues to innovate, shifting from simple product supply to technical cooperation and customized services, helping pharmaceutical companies optimize their research and development processes and enhance market competitiveness.

With the advancement of analytical technology and the improvement of quality standards, the role of reference reagents in the entire life cycle of drug development will become more critical. The reference reagent industry is developing towards higher purity, stability, and accuracy. Our company will continue to monitor changes in regulations and policies, technological innovation trends, and strengthen industry university research cooperation to jointly promote the high-quality development of the reference reagent industry and provide solid support for global pharmaceutical research and development.