Teduglutide

Short bowel syndrome, a chronic consumptive disease caused by insufficient intestinal absorption area, has long relied on parenteral nutrition support to sustain patients' survival. Complications such as accompanying infections and liver function injury severely reduce patients' quality of life. Teduglutide is a glucagon-like peptide-2 (GLP-2) analog. By activating GLP-2 receptors on intestinal epithelial cells, it promotes the proliferation of intestinal mucosal cells, inhibits apoptosis, increases intestinal villus height and crypt depth, and thus improves the intestinal nutrient absorption capacity. It is mainly used for the treatment of short bowel syndrome in people aged one year and above, and can help patients reduce or even get rid of dependence on parenteral nutrition.

The global number of patients with short bowel syndrome exceeds 100,000, among which about 40% require long-term parenteral nutrition support. Driven by the improvement of patient diagnosis and treatment rate and the popularization of specialized treatment awareness, the global market size of teduglutide has maintained steady growth in recent years. It exceeded USD 1.3 billion in 2023, with a compound annual growth rate of around 12%. At present, the market is still dominated by the original research product, with Europe and the United States as the core consumer markets. There is no approved generic drug in China at present, and there is a large unmet space for clinical demand, making it a popular layout variety in the field of rare disease drugs.

The original research enterprise of teduglutide is Takeda Pharmaceutical, with the trade name Gattex. Its US compound patent expires in 2027, and the core European patent expires in 2028. The dosage form approved for the original research product is injection, with two specifications of 0.88mg/1.5ml and 3.8mg/5ml. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Chinese List of Chemical Drugs*. Up to now, there is no teduglutide preparation approved for marketing in China, and there is no public registration number in A status or I status on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO currently provides a full set of impurity reference standards for teduglutide API. Most products are in stock. In-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple national regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the diversified needs of pharmaceutical enterprises in the stages of drug research and development, quality research and registration.