Recently, the semaglutide side chain synthesized by the enzyme product successfully passed the Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA). This is another important milestone achieved by the enzyme product in the field of peptide biopharmaceuticals, following the completion of the filing of its semaglutide API and main chain. It fully demonstrates the company’s technical strength and compliance capabilities in the entire semaglutide industry chain, marking the continuous progress and important breakthrough of the enzyme product in the global pharmaceutical field.
The Drug Master File (DMF) filing with the U.S. Food and Drug Administration ( FDA ) is a formal document used in the pharmaceutical industry to submit information about drug ingredients, manufacturing processes, quality control, and other related information . It aims to comprehensively demonstrate key aspects of a product’s manufacturing process, raw material selection, chemical characterization analysis, quality control methods, and stability data, ensuring that the drug meets the FDA ‘s stringent standards and laying a solid foundation for the drug’s quality, safety, and efficacy.
1. Continuously explore the field of drug peptides
Currently, the biosynthetic semaglutide API, main chain, and side chain of the enzyme product have all been registered. The semaglutide series of products have achieved a breakthrough in production capacity and efficiency, with high quality stability and economic efficiency. The enzyme product is continuously exploring the field of drug peptides, and based on its experience in peptide industry research and commercial application, it is using synthetic biotechnology to achieve large-scale green production of drug peptides.
Through the deep application of synthetic biotechnology, enzyme products have not only promoted the green innovation of drug peptide production, but also demonstrated a dual breakthrough in improving product quality stability and economic efficiency, with smegglutinin as a benchmark, providing efficient and sustainable active raw material support for the global biopharmaceutical industry chain.
2. Regarding finished enzyme products
Enzyme Products is committed to becoming a global leader in green active ingredients . Utilizing next-generation synthetic biology technology, Enzyme Products focuses on the green production of bioactive ingredients such as peptides, proteins, sugars, nucleic acids, and lipids. Leveraging over 20 years of research and industry experience from its founding team, the company has established a leading multidisciplinary technology platform in China. It has achieved large-scale production of dozens of green active ingredients, including Smegglutinin, S-Pros-Xylane, Ergothioneine, Ectoin, Collagen Tripeptide, Human Milk Oligosaccharides, Ceramides, NAD+, NMN, Copper Peptide, Carnosine, Glutathione, and Rhodiola Rosea glycoside. The company has cumulatively provided high-quality green active ingredients to over 2,000 well-known companies in the fields of functional skincare, biomedicine, nutrition and health, and animal nutrition .
The company ranks among the top international companies in terms of R&D investment, scale, and output value. It has undertaken multiple key provincial and municipal R&D projects, applied for more than 200 invention patents, and received more than ten national and local titles, including National Specialized, Refined, and Innovative Small Giant Enterprise, National High-tech Enterprise, Guangdong Provincial Engineering Center, Guangdong Provincial Postdoctoral Innovation Practice Base, Shenzhen Overseas High-level Talent Team, Shenzhen Potential Unicorn Enterprise, Zhuhai Innovation and Entrepreneurship Team, and Gansu Provincial Specialized, Refined, and Innovative Small and Medium-sized Enterprise. It has also been recognized as one of the Top 100 Future Unicorns in China in 2025, one of Deloitte China’s Top 50 High-Tech and High-Growth Enterprises in 2024, one of Deloitte Shenzhen’s Top 20 High-Tech and High-Growth Enterprises in 2024, the Harvard Business Review High-Energy Innovation Team Award in 2023, and one of Shenzhen’s Top 100 High-Growth Enterprises in 2022.