Recently, Guangzhou Enzyme Products Biotechnology Co., Ltd. (hereinafter referred to as Enzyme Products) has achieved another major breakthrough in the field of peptide biopharmaceuticals—its biosynthesized smegglutinin has successfully passed the Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA) (DMF Number Assigned: 039791). This achievement marks a new stage in Enzyme Products’ research and development in the field of peptide biopharmaceuticals, representing another milestone.
The finished enzyme product fully leverages the company’s comprehensive advantages in synthetic biology, artificial intelligence, engineering technology, separation technology, and green chemistry. Combined with the company’s globally leading “green bio-manufacturing platform,” it has achieved major technological breakthroughs in many areas, including novel gene editing technology, specific enzyme modification technology, strain modification technology, high-density fermentation technology, bio-conjugation technology, and the application of novel purification technologies . This series of technological innovations has not only enabled the production capacity and efficiency of semaglutide API to achieve orders-of-magnitude breakthroughs, but also ensured its stable and controllable quality and significantly improved product economics.
With over 20 years of research and industrial expertise, the team behind the enzyme product has established outstanding R&D capabilities in peptides, proteins, oligosaccharides, and oligonucleotides. The company focuses on the creation and production of high-quality active ingredients, committed to assisting global clients in efficiently developing “green active ingredients .” The successful FDA DMF filing for the enzyme product Smegglutinin not only demonstrates the company’s unwavering pursuit of technological innovation, industrialization practices, quality systems, and global compliance, but also reflects the full recognition of the enzyme product’s R&D innovation, quality system, and product quality by authoritative global regulatory bodies.
Currently, the company has successfully achieved mass production of hundreds of kilograms of semaglutide raw material and maintained a stable market supply, winning unanimous praise from customers of oral and injectable formulations. Furthermore, the company’s industrial park with an annual production capacity of 20 tons of GLP-1RA active pharmaceutical ingredients is currently in the design and site selection phase. Upon completion, it will be the world’s largest GLP-1RA raw material production base. Looking to the future, the company will continue to adhere to independent innovation, relying on its globally leading “Green Bio-manufacturing Platform” and driven by synthetic biology technology, to comprehensively empower the development of the entire “green active raw material” industry chain. It is committed to providing global consumers with more diverse and cost-effective health options, contributing MCPBiotechnology’s strength to human health!
Regarding Smeglucopyrithione
Semaglutide, also known as semaglutide, is a leading representative of second-generation long-acting GLP-1 receptor agonists (GLP-1RAs), exhibiting significant blood sugar-lowering and weight-loss effects. In 2023, its global sales reached US$21.2 billion . In December 2023, GLP-1RA drugs topped Science magazine’s list of the top ten scientific breakthroughs of the year. Since its launch in the US in 2017, semaglutide has gained widespread recognition for its remarkable efficacy and successfully entered the Chinese market in April 2021. Currently, semaglutide has received marketing approval for multiple indications, including long-term weight control in adults with type 2 diabetes, overweight or obesity, and adjuvant therapy for cardiovascular disease and prevention of major cardiovascular events in overweight or obese patients. Nearly 20 other indications are in different stages of clinical research. Notably, it is the only FDA-approved anti-obesity drug for adolescents, further demonstrating its leading position in the anti-obesity field. Given its broad application prospects and solid research data, semaglutide has become one of the most watched peptide drugs. Market demand continues to grow, and the global market is experiencing a supply shortage; it has been included in the FDA’s List of Drugs in Shortage.
Regarding FDA DMF
A Drug Master File (DMF) is a comprehensive compilation of drug information submitted to the FDA by the drug manufacturer or supplier. It aims to fully demonstrate key aspects of the product’s manufacturing process, raw material selection, chemical characterization analysis, quality control methods, and stability data, thereby ensuring that the drug meets the FDA’s stringent standards and laying a solid foundation for the drug’s quality, safety, and efficacy.
Regarding enzyme products
Enzyme Products is committed to becoming a global leader in next-generation green active ingredients, employing next-generation synthetic biology technology to focus on the green production of active ingredients such as peptides, proteins, sugars, and nucleic acids. Leveraging over 20 years of research and industry experience from its founding team, the company has successfully built a leading multidisciplinary technology platform in China. It has now achieved mass production of dozens of green active ingredients, including Smeglucopyranoside, Telboropeptide, S -Pros-Xylane, collagen peptides, ergothioneine, NMN, copper peptides, NAD + , ectoine, carnosine series, glutathione series, and various peptides. It has cumulatively provided high-quality green active ingredients to nearly a thousand well-known companies in the fields of biomedicine, functional skincare, and nutritional health.
After seven years of rapid development, the company’s enzyme products have ranked among the top domestic enterprises in terms of R&D investment, company scale, and output. It has applied for over 100 invention patents and has received numerous national and local honors, including National Specialized and Innovative Small Giant Enterprise, National High-tech Enterprise, Shenzhen Specialized and Innovative Small and Medium-sized Enterprise , Shenzhen Potential Unicorn Enterprise, Shenzhen Postdoctoral Innovation Practice Base, Shenzhen Top 30 Medical and Health Innovation Enterprises, Zhuhai Innovation and Entrepreneurship Team, and Gansu Specialized and Innovative Small and Medium-sized Enterprise. Furthermore, in 2022, the company was listed among Shenzhen’s Top 100 High-Growth Enterprises (ranked first among unlisted biotech companies), and in 2023, it was selected as a Harvard Business Review High-Energy Innovation Team, demonstrating its outstanding strength and innovative potential in the industry.