Major Debut | Leading Medical’s Comprehensive Diabetes Solution Makes Its Mark at an Industry Conference, Achieving Another Breakthrough in End-to-End Domestic Substitution

On March 20, the offline launch forum for the “2026 China In Vitro Diagnostics Industry Development Report” was held. Zhang Yujie, General Manager of Nanjing Leading Medical, was invited to deliver a keynote speech and officially unveil the report. Liding’s Comprehensive Diabetes Management Solution , leveraging end-to-end, independently controllable technological achievements to deliver a Chinese solution for diabetes diagnostics to the industry.

Deeply rooted in the IVD sector, we fortify our proprietary R&D foundation through innovation.

Founded in 2019, Leading Medical is a national high-tech enterprise and a specialized, refined, distinctive, and innovative SME in Jiangsu Province. It has established end-to-end IVD industry-chain capabilities under a “one core, two wings” group structure:

The parent company, Leading Medical, focuses on the development of core raw materials and methodologies; Ningpu Medical has deepened its expertise in infectious disease quality control reagents and established the Ningpu Sub‑Repository of the Jiangsu Provincial Center for the Conservation and Innovative Utilization of Agricultural Microbial Resources, thereby acquiring a rare and valuable microbial resource bank. Pengpu Medical offers innovative CDMO services to research institutions, medical consortia, and distributors, helping clients achieve a seamless transition from “concept” to “finished product.” ；
Total operating area: 12,000㎡, with a 3,000㎡ GMP-compliant workshop and a BSL-2 biosafety laboratory, all ISO‑certified. 13485, ISO 9001 authoritative certification;
The company places great emphasis on innovation and intellectual property. Approximately 10 new invention patents are granted each year. , with a cumulative total of 83 patent applications (50 invention patents, 38 granted), participation in the publication of 3 first‑quartile SCI articles, and involvement in one national key project on major infectious diseases;
In collaboration with more than ten universities, including Hunan University, Southeast University, and Jiangsu University, the company has established a industry–university–research collaborative framework. The company’s founder, Zhang Yujie, has been appointed as an industry mentor at both Hunan University and Jiangsu University.

Panoramic solution unveiled, with six major platforms strategically positioned to address industry pain points.

Founder Zhang Yujie emphasized in his speech that, with respect to diabetes testing services, Leading has adopted a forward-looking strategic approach. Biochemical turbidimetry, enzymatic assays, specific protein analysis, HPLC, POCT fluorescence chromatography, and boronic acid affinity chromatography—six major mainstream testing platforms. It has consistently focused on domestic substitution for critical raw materials, developing a comprehensive, end-to-end solution that covers the entire diabetes care continuum.

The solution’s core technological breakthrough directly addresses the industry’s most pressing pain points:

Core reagents: third-generation iteration leads the industry. : As the core component of the assay, the turbidimetric reagent has undergone three generations of technological upgrades, culminating in the launch of a globally exclusive monoclonal antibody–oligomer dual-reagent system. In‑run precision, expressed as CV, is as low as 0.37%, and its correlation with the HPLC gold standard reaches R² = 0.9905, with performance that comprehensively surpasses that of imported products.
Domestic breakthrough achieved in critical bottleneck materials. : A proprietary blue dye specifically designed for boronic acid affinity chromatography, with a single-batch yield exceeding 60 g, has broken the international monopoly and been integrated into the supply chains of leading European companies.
Calibration and quality control materials pave the way for a breakthrough in the industry. Addressing a longstanding industry challenge in the calibration and quality‑control of glycated hemoglobin assays: Previously, the market offered only two primary sources—imported products and clinical samples. The former is costly, suffers from limited production capacity, and faces stringent regulatory hurdles, while the latter poses biosafety risks and suffers from poor batch‑to‑batch consistency. After years of R&D, Leading has achieved key breakthroughs, developing proprietary calibration and quality‑control materials as well as linear reference substances that have undergone rigorous validation by leading domestic IVD manufacturers. These innovations position Leading to become the first domestically developed, compliant, mass‑produced alternative to imported reagents.
Deep adaptation across the entire lifecycle and all scenarios It covers diabetes‑related testing indicators across the entire life cycle—risk prediction, diagnosis, and treatment monitoring—and provides end-to-end support, from raw materials and reagents to customized services.

Hardcore expertise, building core competitiveness for domestic substitution.

Leading Medical with Flexible and diversified collaboration models, a full‑chain compliance‑driven quality system, and continuous technological iteration capabilities. Three core strengths, combined Stable and sustainable business performance, with end-to-end intellectual property protection across the entire value chain. Two robust safeguards ensure that global customers receive stable, compliant, and cost-effective products and services.

Looking ahead, Leading Medical will continue to deepen its expertise in the diabetes‑testing field, leveraging technological innovation to break international monopolies, further refine its end-to-end diabetes management solutions, and collaborate with industry partners to drive high‑quality development of China’s IVD sector, thereby safeguarding public health.

About Leading Medical

Nanjing Leading Medical Technology Co., Ltd. specializes in critical raw materials for in vitro diagnostics and comprehensive customized reagent solutions. Its products are available in nearly 40 countries and regions worldwide, making it a key player in China’s IVD diabetes‑testing sector as a domestic alternative to imported technologies.

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