Market Landscape

Since 2022, the volume-based procurement (VBP) program has been steadily reshaping China’s biochemical diagnostic reagent market:

• Liver function reagents: Initiated in 2022, selected in 2023, implemented across 23 provinces.
• Renal function & myocardial enzyme reagents: Launched in 2023, with 14 provinces already in execution.
• Glucose metabolism reagents: Started in 2024, involving 32 biochemical assay products, currently in public review.

Over the past three years, VBP has covered almost the entire biochemical testing sector, creating intense cost pressures for manufacturers. Against this backdrop, domestic substitution and technological independence have become an urgent priority.

Hzymes Biotech has achieved a historic milestone by developing the first China-made alpha-amylase assay substrate — Ethyliden-4-nitrophenyl-α-D-maltoheptaosid (EPS-G7). This innovation ends long-standing foreign monopoly and marks the first domestic breakthrough in this “bottleneck” technology.

Clinical Significance of α-Amylase Detection

Acute pancreatitis (AP) is one of the most common emergencies in gastroenterology, with an annual incidence of 0.71% in China. Nearly 20% of cases progress to moderate or severe AP, with mortality rates as high as 30%.

Alpha-amylase (α-AMY) is a key biomarker for the diagnosis of acute pancreatitis.

The International Federation of Clinical Chemistry (IFCC) recommends EPS-G7 as the chromogenic substrate for alpha-amylase assay development.

Reaction principle:

• EPS-G7 is hydrolyzed by α-amylase to release p-nitrophenyl oligosaccharides.
• These are further hydrolyzed by α-glucosidase (included in the kit) into p-nitrophenol (pNP).
• The absorbance of pNP at 400 nm is linearly correlated with its concentration, enabling quantitative measurement of α-amylase activity.

Fig. 1 Principle of quantitative detection of α-amylase activity using EPS-G7

Breaking Global Monopoly with Innovative Synthesis

EPS-G7 is a highly complex glycoside compound, notoriously difficult to synthesize. For decades, only one multinational company held the industrial know-how, protecting its process as a trade secret and thereby monopolizing the global EPS-G7 supply. This resulted in:

• Tight supply chain dependence
• Extremely high prices
• Limited access for domestic IVD reagent manufacturers

Fig. 2 Chemical synthesis process of EPS-G7

Hzymes has overcome this world-class challenge, pioneering a combined chemical–enzymatic synthesis process and achieving kilogram-scale industrial production of EPS-G7 — the first domestic substitution breakthrough.

Technology Highlights

• Novel biosynthetic route: Abandoned conventional glycosyltransferase strategies; innovatively adopted a cyclodextrin hydrolase glycosyl-transfer pathway.
• AI-driven enzyme engineering: Leveraged directed evolution and AI-assisted design to optimize enzyme variants.
• Performance leap:
• Reduced isomer ratio from 40% to <1%
• Increased transglycosylation yield from 51 g/L to 153 g/L
• Intellectual property: Patents have been filed with the China National Intellectual Property Administration (CNIPA) and a PCT international application is in progress.

Product Performance Advantages

Hzymes’ EPS-G7 offers higher purity, lower impurities, superior stability, and better compatibility compared with imported substrates:

• Purity: ≥95% (vs. ≥90% for leading foreign brands)
• Impurity control: pNP ≤0.01%, pNPG7 ≤0.1%

• Stability:
• Heat-stability for 15 days, deviation <2%
• Open-vial stability for 25 days, deviation <3.5%
• Batch-to-batch consistency: Deviation ≤5% across clinical linear ranges

Comparison test with imported substrates on clinical samples shows excellent correlation, with an average deviation of <2.5%

• Excellent stability

After 15 days of heat stability testing, the variation in clinical sample results was less than 2%

After 25 days of open-vial stability, the variation in clinical sample results was less than 3.5%

• Assay compatibility: Seamless replacement for imported substrates, correlation bias <2.5%
• Strict quality control, large production capacity, dual control, reducing batch-to-batch variation

Randomly select three batches of reagents and compare them using clinical samples covering the linear range; the average batch-to-batch variation does not exceed 5.0%.

Market Potential

With the rapid expansion of the biochemical diagnostics market and nationwide VBP implementation, high-performance domestic assay substrates are in strong demand.

EPS-G7 localization by Hzymes:

• Reduces reagent development and replacement barriers
• Strengthens supply chain security and cost efficiency
• Enhances China’s IVD raw materials independence

Moving forward, Hzymes Biotech will continue to focus on innovative biochemical assay substrates and enzyme-based raw materials, delivering high-quality, reliable, and scalable solutions for global diagnostic manufacturers.

Conclusion

The successful domestic development of EPS-G7 for alpha-amylase detection is not just a product milestone — it is a strategic breakthrough for China’s IVD industry.

It eliminates foreign dependence, ensures supply chain resilience, and paves the way for cost-effective diagnostic innovation.

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