Semaglutide is a GLP-1 receptor agonist peptide drug active pharmaceutical ingredient (API), mainly used to treat type 2 diabetes and obesity in adults. Regarding its raw materials and production process, the main technical routes and production forms on the market are as follows:
1. Core Production Process
The production of semaglutide API mainly follows two technical routes:
Total Synthesis (SPPS): This is solid-phase peptide synthesis, starting from the carboxyl end of the peptide and cyclically coupling amino acids on a solid-phase support according to the peptide sequence. This method is convenient for automated operation, but material consumption is high, costs are higher, and long fatty acid chains can cause steric hindrance, affecting yields.
Recombinant and Semi-synthetic Method: This involves fermenting the peptide backbone (the 29-peptide intermediate) using engineered strains like E. coli, followed by two chemical reactions (such as side-chain coupling and deprotection) to obtain the final product. This semi-synthetic/recombinant route has advantages such as high crude purity, high final product yield, and simple steps, making it very suitable for industrial production.
2. Key Intermediate: Semaglutide 29-Peptide
The semaglutide 29-peptide intermediate (also known as the semaglutide backbone, GLP-1(9-37)) is a crucial starting material for synthesizing this API. It is usually expressed through recombinant E. coli, then purified via enzymatic cleavage, chromatography, and freeze-drying. At present, this intermediate has achieved commercial-scale supply, with domestic companies such as Jibai Kang offering high-purity products.
3. Major Domestic Suppliers and Market Status
Representative companies: Fujian Genor Biopharma is the world's first company to have registered DMFs for both "recombinant" and "total synthesis" API manufacturing processes. Other domestic companies involved in GLP-1 API supply include Sainuo Biotech, WuXi AppTec, Notai Biotech, Hanyu Pharma, and Puli Pharma (successfully developed via synthetic biology).
Keywords: Semaglutide manufacturer
