Takeda Pharmaceutical’s Teduglutide Filed for Marketing Approval in China

The Center for Drug Evaluation (CDE) website in China indicates that Japan-based Takeda Pharmaceutical Co., Ltd’s best-in-class injectable therapy teduglutide has been filed for marketing approval. This marks a significant step for the drug in the Chinese market.

Drug Background
Teduglutide, the first and only natural glucagon-like peptide-2 (GLP-2) drug approved in Europe and the US in 2012, received approval in Japan for treating short bowel syndrome (SBS) in 2021. It is designed to help patients with SBS improve nutrient absorption and reduce the need for parenteral nutrition.

Mechanism and Efficacy
SBS is caused by the partial or complete surgical removal of the small and/or large intestine, leading to poor absorption of fluids and nutrients. Teduglutide aids in enhancing the absorptive capacity of the remaining intestinal tract, decreasing the frequency and volume of parenteral nutrition required. With a half-life of over one hour and complete renal metabolism, efficacy studies in adults and children have demonstrated that teduglutide increases fluid absorption in the gut.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry